Bringing light into darkness: A multiple baseline mixed methods case series evaluation of Augmented Depression Therapy (ADepT)

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The sample were aged between 20 and 70, predominantly female, mostly not employed, all of White British ethnic origin, and none declared a disability.

“The sample were aged between 20 and 70, were predominantly female, were mostly not employed, and all were of White British ethnic origin.None declared themselves as having a disability.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Mean depression severity was in the moderately severe range, mean anxiety severity was in the moderate range, and mean WSAS severity was in the severe range.

“Mean depression severity was in the moderately severe range, mean anxiety severity was in the moderate range, and mean WSAS severity was in the severe range.”

May combine two claims.

Mean WEMWBS score was well below general population averages, mean SHAPS score was well above general population averages, and mean PANAS positive affect was well below and negative affect was well above general population averages.

“Mean WEMWBS score was well below general population averages”

• Also stated in: § 3.1. Recruitment, data completeness and demographic characteristics · boosted

  “mean SHAPS score was well above general population averages”

• Also stated in: § 3.1. Recruitment, data completeness and demographic characteristics · boosted

  “mean PANAS PA was well below, and PANAS NA was well above, general population averages”

• cites Franken et al., 2007 sourceNot checked yet

  Not checked in the free run.

• cites Crawford et al., 2009Not checked yet

  Not checked in the free run.

May combine two claims.

Barriers to engagement included negative previous experiences of talking therapy, depression reducing motivation, and practical life issues.

“Barriers to engagement included negative previous experiences of talking therapy, depression reducing motivation, and practical life issues.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The sample predominantly had recurrent depression (mean of 8 episodes, mean age of first onset in their twenties), with three participants having attempted suicide in the past at least once.

“The sample predominantly had recurrent depression (mean of 8 episodes, with mean age of first onset in their twenties), with three participants having attempted suicide in the past at least once.”

May combine two claims.

There was no significant change in fear of positive emotions on the ACS-P or amplifying appraisals on the RPA.

“There was no significant change in fear of positive emotions on the ACS-P, or amplifying appraisals on the RPA.”

May combine two claims.

Clients viewed the establishment of a positive, caring therapeutic relationship; identifying and living according to values; building self-care; engaging with simple everyday pleasures; socially reconnecting; having clear goals; and having a practical focus as particularly helpful aspects of ADepT.

“Aspects of ADepT that were viewed as particularly helpful included: the establishment of a positive, caring therapeutic relationship; identifying and living according to their values; building self-care; engaging with simple everyday pleasures; socially reconnecting; having clear goals; and having a practical focus.”

May combine two claims.

For the PHQ-9, reliable change was observed for eight out of eleven participants (73%) and reliable and clinically significant change for seven out of eleven participants (64%) at posttreatment.

“For the PHQ-9, RC was observed for eight out of eleven participants (73%) and R + CSC was observed for seven out of eleven participants (64%) at the posttreatment assessment point.”

May combine two claims.

The three clients whose depression had not remitted during acute treatment all gave positive feedback about the treatment, identifying clear behavioural gains despite only partial or no symptomatic relief.

“The three clients whose depression had not remitted during acute treatment all gave positive feedback about the treatment, identifying clear behavioural gains they had made despite only partial or no symptomatic relief.”

May combine two claims.

Qualitative interviews indicated ADepT was feasible and acceptable.

“Qualitative interviews indicated ADepT was feasible and acceptable.”

• AssumptionRests on an assumption: The qualitative interviews and analysis were not biased by the first author and intervention developer conducting the qualitative analysis.

May combine two claims.

Handouts and exercises were viewed as constructive, although the volume of homework felt overwhelming to some clients (in clients where English was not the first language or who had dyslexia).

“The handouts and exercises were viewed as constructive, although the volume of homework felt overwhelming to some clients (in clients where English was not the first language or who had dyslexia).”

May combine two claims.

Clients found the future-oriented wellbeing focus of ADepT unexpected but beneficial and leading to improvements in depression.

“Nine out of eleven clients perceived ADepT to have been very helpful, finding the future-oriented wellbeing focus unexpected but beneficial and leading to improvements in depression.”

May combine two claims.

For the WEMWBS, reliable change was seen for seven out of eleven participants (64%) and reliable and clinically significant improvement for six out of eleven participants (55%) at post-treatment.

“For the WEMWBS, RC was seen for seven out eleven participants (64%) and R + CSC improvement was seen for six out of eleven participants (55%) at the post-treatment assessment point.”

May combine two claims.

Four participants were extremely satisfied and five were very satisfied with ADepT.

“Indicating ADepT was acceptable to clients, four were extremely satisfied and five were very satisfied with treatment.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The two participants excluded on the basis of recovering during baseline were both in recovery for depression and anxiety at the end of treatment.

“They were both in recovery for depression and anxiety at the end of treatment.”

May combine two claims.

Autocorrelation between time measures (phase lag of one) varied between -.07 and .71 for PHQ-9 and between 0.08 and 0.87 for WEMWBS.

“Autocorrelation between time measures (using a phase lag of one) varied between -.07 and .71for PHQ-9 and between 0.08 and 0.87 for WEMWBS.”

May combine two claims.

Benchmarking analyses indicated effect sizes were at least comparable, and for some PVS outcomes superior, to existing treatments.

“Benchmarking analyses indicated these effect sizes were at least comparable (and for some PVS outcomes superior) to existing treatments.”

• AssumptionRests on an assumption: The external benchmark trials used for comparison are comparable to the current case series in sample, treatment context, and outcome measurement.

Probably not a substantial claim: may not pass S3 (load-bearing).

One client saw depression as a secondary consequence of fibromyalgia, which they did not feel the therapy had addressed.

“One client saw depression as a secondary consequence of fibromyalgia, which they did not feel the therapy had addressed.”

May combine two claims.

Reliable and clinically significant improvement was observed for 9/11 participants on at least one of wellbeing or depression outcomes, and also across a range of other PVS and NVS outcomes.

“Reliable and clinically significant improvement was observed for 9/11 participants on at least one of these outcomes (and also across a range of other PVS and NVS outcomes).”

• AssumptionRests on an assumption: The ADepT treatment delivered by the three therapists was delivered with sufficient fidelity to represent ADepT.

May combine two claims.

The other participant chose to stop treatment after eleven sessions, having made a full recovery (PHQ-9 = 0 and GAD-7 = 2 at final treatment session) and met their treatment goals.

“The other participant chose to stop treatment after eleven sessions, having made a full recovery (PHQ-9 = 0 and GAD-7 = 2 at final treatment session) and met their treatment goals.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Another client wanted concrete advice about a life issue and was disappointed the therapist explored this Socratically rather than providing answers.

“Another client wanted concrete advice about a life issue, and was disappointed the therapist explored this Socratically rather than providing answers.”

May combine two claims.

Eight of eleven individuals were taking anti-depressants; none reported a change in medication during baseline; three reported a change during acute treatment, with one switching medications and two reducing or stopping medications.

“Eight out of eleven individuals were taking anti-depressants, none of whom reported a change in medication during the baseline phase and three of whom reported a change during acute treatment.One individual switched medications and two individuals individualsreduced or stopped medications”

May combine two claims.

Clients identified areas to improve in the ADepT protocol: redrafting some handouts to be clearer, further emphasising social reconnection, and taking life stage into account more explicitly.

“Areas to improve in the ADepT protocol identified by clients included redrafting some handouts to be clearer, further emphasising social reconnection, and taking life stage into account more explicitly.”

May combine two claims.

Eight participants would be extremely likely to recommend ADepT and one would be likely to recommend ADepT.

“Eight participants would be extremely likely to recommend ADepT and one would be likely to recommend ADepT.”

May combine two claims.

Visual analysis of the time series data reached broadly similar conclusions to the SMA analysis, with the same seven participants appearing to improve on both outcomes.

“This visual analysis reached broadly similar conclusions to the SMA analysis, with the same seven participants appearing to improve on both outcomes.”

May combine two claims.

Eight out of eleven participants made use of the ADepT optional booster sessions, attending on average 2 sessions (SD = 1.94).

“Eight out of eleven participants made use of the ADepT optional booster sessions (attending on average 2 sessions, SD = 1.94).”

Probably not a substantial claim: may not pass S3 (load-bearing).

One participant initially accepted the offer of booster sessions but then withdrew prior to the first scheduled booster as they felt well and had no need of further sessions.

“One participant initially accepted the offer of booster sessions but then withdrew prior to the first scheduled booster as they felt they were well and had no need of further sessions.”

May combine two claims.

Booster sessions were seen as useful, even though not all clients felt the need to take them up.

“Booster sessions were seen as useful, even though not all clients felt the need to take them up.”

May combine two claims.

The pattern of change was not clearly linear, with significant variability over time within and between participants.

“However, the pattern of change was not clearly linear, with significant variability over time within and between participants.”

May combine two claims.

Four participants rated ADepT as extremely acceptable and five rated it as very acceptable.

“Four rated the treatment as extremely acceptable and five rated the treatment as very acceptable.”

May combine two claims.

The two participants excluded from case series analyses on the basis of recovering during baseline both completed a full dose of acute treatment and rated it as acceptable.

“The two participants (P1 and P2) who were excluded from the case series analyses on the basis of recovering during the baseline both completed a full dose of acute treatment and rated it as acceptable.”

May combine two claims.

Seven out of eleven participants (64%) met criteria for reliable improvement on the PHQ-9 and eight out of eleven (73%) met criteria for reliable improvement on the GAD-7.

“Seven out of eleven participants (64%) met criteria for reliable improvement on the PHQ-9 and eight out of eleven participants (73%) met criteria for reliable improvement on the GAD-7.”

May combine two claims.

For SHAPS and GAD-7, one-year follow-up levels were significantly improved relative to intake and pre-treatment and did not differ relative to post-treatment or two-month follow-up, except that symptom levels had further significantly improved from two-month follow-up to one-year follow-up (ps < .04).

“A similar pattern emerged for the SHAPS and GAD-7, with the exception that symptom levels had further significantly improved from two-month follow-up to one-year follow-up, ps < .04.”

May combine two claims.

There were gains for a majority of participants at all time points for WSAS functioning (RC ≥ 50%, R + CSC ≥ 40%) and PANAS positive and negative affect (RC ≥ 60%, R + CSC ≥ 50%).

“There were also gains for a majority of participants at all time points for WSAS functioning (RC ≥ 50%, R + CSC≥40%) and PANAS positive and negative affect (RC ≥ 60%, R + CSC≥50%).”

May combine two claims.

The qualitative interviews revealed that the wellbeing focus of ADepT was acceptable to and valued by clients, with no evidence that it was experienced as PollyAnna-ish.

“The qualitative interviews revealed that the wellbeing focus of ADepT was acceptable to and valued by clients, with no evidence that it was experienced as”

• cites Dunn, 2012Not checked yet

  Not checked in the free run.

May combine two claims.

There was no significant change from post to two-month follow-up for any measures (ps > .10), except further improvements in PANAS PA over that time period (p = .01).

“There was no significant change from post to two-month follow-up for any measures, ps > .10,with the exception further improvements in PANAS PA over that time period, p = .01(indicating benefits were sustained or extended during the follow-up period).”

May combine two claims.

Anxiety recovery criteria were met by five out of eleven (45%) at post-assessment, five out of ten (50%) at two-month follow-up, and five out of eight (63%) at one-year follow-up.

“Anxiety recovery criteria were met by five out of eleven (45%) participants at post-assessment, five out of ten (50%) participants at two-month follow-up, and five out of eight (63%) participants at one-year follow-up.”

May combine two claims.

Of the two participants who met diagnostic criteria during follow-up, both had scored above the PHQ-9 caseness cut-off immediately post treatment (PHQ-9 post-treatment was 14 for P3 and 25 for P5), indicating they had not fully responded to acute treatment.

“Of the two participants who had met diagnostic criteria during the follow-up period, both of these had scored above the PHQ-9 caseness cut-off immediately post treatment (PHQ-9 post-treatment was 14 for P3 and 25 for P5), indicating they had not fully responded to acute treatment.”

May combine two claims.

P3 was no longer in episode according to the SCID at one-year follow-up, although her PHQ-9 score was 10, just above the caseness cut-off.

“P3 was no longer in episode according to the SCID (although her PHQ-9 score was 10, so just above the caseness cut-off).”

May combine two claims.

At intake and pretreatment, all eleven participants (100%) reported clinically significant levels of depression and ten out of eleven (91%) reported clinically significant levels of anxiety.

“At intake and pretreatment, all eleven participants (100%) reported clinically significant levels of depression and ten out of eleven (91%) participants reported clinically significant levels of anxiety.”

May combine two claims.

There was little evidence of reliable deterioration except that P5 deteriorated on the WEMWBS at two-month follow-up and PANAS positive affect at two-month and one-year follow-up, and P7 deteriorated at one-year follow-up on PANAS negative affect.

“There was little evidence of reliable deterioration except that P5 deteriorated on the WEMWBS at two-month follow-up and PANAS positive affect at two-month and one-year follow-up.P7 also deteriorated at one-year follow-up on PANAS negative affect.”

May combine two claims.

The diagnostic interview at one-year revealed that six out of eight participants (75%) interviewed had not relapsed during follow-up and met criteria for sustained recovery.

“The diagnostic interview at one-year revealed that six out of eight participants [75%] interviewed had not relapsed during the follow-up period and therefore met criteria for sustained recovery.”

May combine two claims.

There was significant improvement from intake to post, intake to two-month follow-up, pre to post, and pre to two-month follow-up for most measures, with the exception that the pre to two-month follow-up comparison for PANAS PA was not significant (p = .16).

“There was also significant improvement intake to post, ps < .01,intake to two-month follow-up, ps < .03,pre to post, ps < .02,and pre to twomonth follow-up, ps < .05.The one exception was that the pre to twomonth follow-up comparison for PANAS PA was not significant, p = .16.”

May combine two claims.

The 95% confidence intervals of the effects were broad and crossed zero.

“Reflecting the sample size in the case series, the 95% confidence intervals of the effects were broad and crossed zero.”

May combine two claims.

Depression recovery criteria were met by eight out of eleven (73%) at post-assessment, five out of ten (50%) at two-month follow-up, and four out of eight (50%) at one-year follow-up.

“Depression recovery criteria were met by eight out of eleven (73%) participants at the post-assessment, five out of ten (50%) participants at two-month follow-up assessment, and four out of eight (50%) participants at one-year follow-up assessment.”

May combine two claims.

For PANAS NA, one-year follow-up levels were only trend lower than pre-treatment NA levels (p = .054), but otherwise the pattern was the same as for PHQ-9, WEMWBS, PANAS PA and WSAS.

“For PANAS NA, one-year follow-up levels were only trend lower than pre-treatment NA levels, p = .054,but otherwise the pattern was the same as for PHQ-9, WEMWBS, PANAS PA and WSAS.”

May combine two claims.

P5 met criteria for a current major depressive episode at one-year follow-up on the SCID and continued to score above the PHQ-9 cut-off.

“P5 met criteria for a current major depressive episode at one-year follow-up on the SCID and continued to score above the PHQ-9 cut-off.”

May combine two claims.

On the subset of eight individuals with complete data, one-year follow-up levels were significantly improved relative to intake and pre-treatment (ps < .03) but did not differ relative to post-treatment or two-month follow-up (ps > .13) for PHQ-9, WEMWBS, PANAS PA, and WSAS.

“As intended, one-year follow-up levels were significantly improved relative to intake and pre-treatment, ps < .03,but did not differ relative to post-treatment or two-month follow-up, ps > .13,for PHQ-9, WEMWBS, PANAS PA, and WSAS.”

May combine two claims.

A significant pre-post improvement for WEMWBS and PHQ-9 in time series analysis was shown for four out of five participants in the mild PHQ-9 range (10-14); for two of three participants in the moderately severe range (15-19); and for one out of three participants in the severe range (>19).

“A significant pre-post improvement for WEMWBS and PHQ-9 in time series analysis was shown for four out of five participants in the mild PHQ-9 range (10-14); for two of three participants in the moderately severe range PHQ-9 range (15-19); and for one out of three participants in the severe range (> 19).”

May combine two claims.

GAD-7 improvements at post and two-month follow-up were observed for a smaller proportion of participants (RC ≥ 30%; R + CSC ≥ 30%), but there were GAD-7 gains for a majority at one-year follow-up (RC = 75%; R + CSC = 75%).

“GAD-7 improvements at post and two-month follow-up assessment were observed for a smaller proportion of participants (RC ≥ 30%; R + CSC≥30%) but there were GAD-7 gains for a majority of participants at one-year follow-up (RC = 75%; R + CSC = 75%).”

May combine two claims.

The 95% confidence intervals of the effects were broad and crossed zero, reflecting the sample size in the case series.

“Reflecting the sample size in the case series, the 95% confidence intervals of the effects were broad and crossed zero.”

May combine two claims.

P5 failed to show reliable improvement for either primary outcome measure immediately post-treatment; despite attending all booster sessions, this client reported no further improvement in wellbeing or depression at subsequent follow-ups and showed deterioration on wellbeing at two-month follow-up.

“P5 also failed to show reliable improvement for either primary outcome measure immediately post-treatment.Despite attending all of the booster sessions, this client reported no further improvement in wellbeing or depression at subsequent follow-ups (and showed deterioration on wellbeing at two-month follow-up).”

May combine two claims.

Inspection of the individual items of the WEMWBS and PHQ-9 indicates there is substantial overlap in their content, although there is a clear difference in whether items are positively or negatively phrased.

“Inspection of the individual items of the WEMWBS and PHQ-9 indicates there is substantial overlap in their content (although clear difference in whether items are positively or negatively phrased).”

May combine two claims.

Nine out of eleven participants showed reliable improvement from pre to post treatment on the PHQ-9 and/or WEMWBS (82%; exceeding the 60% target).

“Nine out of eleven participants showed reliable improvement from pre to post treatment on the PHQ-9 and/or WEMWBS (82%; exceeding the 60% target).”

May combine two claims.

In qualitative interviews, some clients described improvements in values-consistent functioning that were not captured by either measure (for example, the two nonresponders both described behavioural gains they had made during treatment).

“Consistent with this position, in the qualitative interviews, some clients described improvements in values-consistent functioning that were not captured by either measure (for example, the two nonresponders both described behavioural gains they had made during treatment).”

May combine two claims.

P3 failed to show reliable improvement in depression and wellbeing immediately post-treatment, but engaged with some booster sessions and showed significant gains on both outcomes at one-year follow-up.

“P3 failed to show reliable improvement in depression and wellbeing immediately post-treatment, but did engage with some of the booster sessions and showed significant gains on both outcomes at oneyear-follow-up.”

May combine two claims.

Both P3 and P5 rated the treatment as acceptable and in qualitative interviews reported having made meaningful behavioural changes as a result of engaging in sessions.

“Despite these mixed outcomes, both clients rated the treatment as acceptable and in qualitative interviews reported having made meaningful behavioural changes as a result of engaging in sessions.”

May combine two claims.

The sample were predominantly cases of moderate to severe, treatment resistant depression, with comorbid anxiety, recruited from NHS waiting lists.

“The sample were predominantly cases of moderate to severe, treatment resistant depression, with comorbid anxiety, recruited from NHS waiting lists.”

May combine two claims.

Existing psychological treatments for depression have focused on the negative valence system (NVS) and neglected the positive valence system (PVS), which may contribute to sub-optimal outcomes.

“Existing psychological treatments have focused on the NVS and neglected the PVS, which may contribute to sub-optimal outcomes.”

• Also stated in: § 1. Introduction · plain

  “However, existing psychological treatments primarily focus on NVS elevations and neglect the PVS (Dunn, 2012;Dunn & Roberts, 2016).”

• cites Dunn, 2012Not checked yet

  Not checked in the free run.

• cites Dunn & Roberts, 2016Not checked yet

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Classified as probably not a substantial claim.

ADepT co-targets reduction of depression symptoms and enhancement of wellbeing/functioning.

“To help foster positive recovery, ADepT co-targets reduction of depression symptoms and enhancement of wellbeing/functioning.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The study followed guidelines in the design, analysis and reporting of case series to ensure the method was applied optimally.

“We followed guidelines in the design, analysis and reporting of case series to ensure the method was applied optimally”

• cites Kratochwill et al., 2013Not checked yet

  Not checked in the free run.

• cites Smith, 2012 sourceNot checked yet

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• cites Tate et al., 2016Not checked yet

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May combine two claims.

Sample size for intensive time series analysis was guided by the recommendation of a minimum of three replications of the intervention effect, and three therapists were asked to treat at least three cases each.

“However, guidelines recommend a minimum of three replications of the intervention effect (Kratochwill et al., 2010).To increase confidence in the generalisability of the findings, we asked three different therapists to deliver the treatment, aiming for each to treat at least three cases.”

• cites Kratochwill et al., 2010Not checked yet

  Not checked in the free run.

Classified as probably not a substantial claim. May combine two claims.

Participants were randomised to different baseline assessment lengths between three and eight weeks, with a random sequence generated by a computer-based package.

“Participants were randomised to different baseline assessment length (between three and eight weeks), with a random sequence generated by a computer-based package.”

May combine two claims.

The key element of recovery to clients is enhanced functioning in valued life domains and increased wellbeing.

“The key element of recovery to clients is enhanced functioning in valued life domains (i.e. a reduction in the disability burden of depression) and increased wellbeing (the capacity to experience pleasure, meaning and social connection in life; Keyes, 2005) (Demyttenaere et al., 2015;Zimmerman et al., 2006).”

• cites Demyttenaere et al., 2015Not checked yet

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• cites Zimmerman et al., 2006Not checked yet

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May combine two claims.

The mechanisms targeted by ADepT include elevated dampening appraisals when feeling positive, reduced attentional and mnemonic processing biases to positive information, reductions in experiential processing, and reductions in self-compassion and kindness.

“The mechanisms targeted included: elevated use of dampening appraisals when feeling positive (Burr, Javiad, Jell, Werner-Seidler, & Dunn, 2017;Dunn et al., 2018;Werner-Seidler, Banks, Dunn, & Moulds, 2013); reduced attentional and mnemonic processing biases to positive information”

• Also stated in: § 1. Introduction · plain

  “reductions in experiential processing (e.g., see Gadeikis, Bos, Schweizer, Murphy, & Dunn, 2017;Teasdale, 1999); and reductions in self-compassion and kindness (e.g.see Hofmann, Grossman, & Hinton, 2011).”

• cites Burr, Javiad, Jell, Werner-Seidler, & Dunn, 2017Not checked yet

  Not checked in the free run.

• cites Dunn et al., 2018Not checked yet

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• cites Werner-Seidler, Banks, Dunn, & Moulds, 2013 sourceNot checked yet

  Not checked in the free run.

Classified as probably not a substantial claim. May combine two claims.

Fourteen participants entered the case series but three were excluded: P1 and P2 recovered during baseline, and P14's primary presenting problem was a head injury.

“Fourteen participants entered the case series but three were excluded (P1 and P2 as they recovered during the baseline phase [PHQ-9 change > 6 points and scoring < 10 at pre-treatment]; P14 because it became apparent that their primary presenting problem was a head injury 3 ).”

May combine two claims.

PVS reductions predict acute symptom severity, poor treatment response, and a chronic, relapsing future course in depression.

“Whilst it has long been recognised that NVS elevations are prognostically important in depression, it is now increasingly acknowledged that PVS reductions also predict acute symptom severity, poor treatment response, and a chronic, relapsing future course (Spijker, Bijl, De Graaf, & Nolen, 2001;Uher et al., 2012, McMakin et al., 2012; see reviews by Dunn & Roberts, 2016;Dunn, in press).”

• cites Spijker, Bijl, De Graaf, & Nolen, 2001Not checked yet

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• cites Uher et al., 2012 sourceNot checked yet

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• cites Dunn & Roberts, 2016Not checked yet

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Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Eight of eleven participants were contactable after one year, all agreed to take part, and P4, P9, P13 could not be contacted, all of whom had shown reliable improvement on PHQ-9 during acute treatment.

“Eight out of eleven participants were contactable after one-year for the additional followup, all of whom agreed to take part.P4, P9, P13 could not be contacted at one-year follow-up, all of whom had showed reliable improvement on the PHQ-9 during acute treatment.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Nine of eleven participants took part in the post-treatment qualitative interview.

“Nine out of eleven participants took part in the post-treatment qualitative interview.”

May combine two claims.

The WEMWBS and PHQ-9 have been shown to be sensitive to change during treatment and had acceptable reliability in the current sample.

“Both measures have been shown to be sensitive to change during treatment (Kroenke, Spitzer, Williams, & Lowe, 2010;Maheswaran, Weich, Powell, & Stewart-Brown, 2012) and had acceptable reliability in the current sample”

• cites Kroenke, Spitzer, Williams, & Lowe, 2010 sourceNot checked yet

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• cites Maheswaran, Weich, Powell, & Stewart-Brown, 2012Not checked yet

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May combine two claims.

Participants were included in final analyses only if they remained above the clinical cut-off for depression at the end of baseline (PHQ-9≥10) and showed a stable pattern of depression and wellbeing during baseline, with instability defined as reliable change of ≥6 points on PHQ-9 or ≥7 points on wellbeing.

“We only included participants in the final analyses who remained above the clinical cut-off for depression at the end of the baseline phase (PHQ-9≥10) and showed a stable pattern of depression and wellbeing during the baseline phase.”

• Also stated in: § 2.2. Participants · plain

  “We used reliable change for the PHQ-9 (≥6 points) and wellbeing (≥7 points) as the cut-off to indicate the baseline was not stable.”

• cites Kratochwill et al., 2010Not checked yet

  Not checked in the free run.

May combine two claims.

Depression involves elevations in negative valence system (NVS) functioning and reductions in positive valence system (PVS) functioning.

“Two core features of depression are elevations in negative valence system (NVS) functioning and reductions in positive valence system (PVS) functioning.”

• Also stated in: § 1. Introduction · plain

  “These symptoms can be seen as emergent properties of disruptions to two underlying and partly dissociable neurobiological dimensions in depression (Carver & White, 1994;Gray, 1987;Insel et al., 2010;Paulus et al., 2017;Watson, Wiese, Vaidya, & Tellegen, 1999).”

• cites Carver & White, 1994 sourceNot checked yet

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• cites Gray, 1987Not checked yet

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• cites Insel et al., 2010 sourceNot checked yet

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Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

All remaining 11 participants had complete PHQ-9 and WEMWBS data for each weekly assessment, apart from P10 (no treatment week seven data) and P13 (no baseline week two data); these two missing values were substituted with the average of the two values either side.

“All remaining 11 participants had complete PHQ-9 and WEMWBS data for each weekly assessment, apart from P10 (no treatment week seven data) and P13 (no baseline week two data).We substituted these two missing values with the average of the two values either side of them.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The interviewer for diagnostic interviews was not blind to treatment phase.

“The interviewer was not blind to treatment phase.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Complete extended assessment data at pre, post and two-month follow-up were available for ten of eleven participants; P4's post-treatment PHQ-9 and WEMWBS scores were substituted with weekly measures taken at session 15.

“Complete extended assessment data at pre, post and two-month followup were available for ten out of eleven participants (P4 did not complete post-treatment and follow-up assessments).We substituted the post-treatment PHQ-9 and WEMWBS scores for P4 with weekly measures taken at session 15.”

Classified as probably not a substantial claim.

The study set a priori continuation rules for proceeding to pilot trial evaluation of ADepT.

“We set a priori continuation rules allowing us to proceed to pilot trial evaluation of ADepT only if:”

May combine two claims.

Secondary analyses of CPT2 and CPT3 found reductions in positive affect were more marked than elevations in negative affect prior to treatment, there was a smaller repair of positive affect relative to negative affect during treatment, and disturbances were greater in positive affect versus negative affect at the end of treatment.

“Secondary analyses revealed that reductions in PA were more marked than elevations in NA prior to treatment; there was a smaller repair of PA relative to NA during treatment; and disturbances were greater in PA versus NA at the end of treatment (Dunn et al., in press).”

• cites Dunn et al., in pressNot checked yet

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Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing). May combine two claims.

For secondary group level analyses, the study aimed to be powered to detect a large effect size and intended to recruit at least 13 participants.

“For the secondary group level analyses (used to generate effect sizes for benchmarking purposes), we aimed to be powered to detect a large effect size in the key pre-post analysis (based on the continuation rule that ADepT needed to demonstrate a large effect size on the primary outcome variables).We therefore intended to recruit at least 13 participants.”

May combine two claims.

Case series methods can assess treatment acceptability and feasibility, provide preliminary evidence of effectiveness and proof-of-concept, help refine and optimise the protocol, and establish if the treatment is likely to be implementable in the target context.

“Case series methods can: assess treatment acceptability and feasibility; provide preliminary evidence of effectiveness and proofof-concept; help refine and optimise the protocol; and establish if the treatment is likely to be implementable in the target context.”

• cites Kazdin, 2011Not checked yet

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• cites Morley, 2017Not checked yet

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May combine two claims.

The seven participants with significant slope change showed significant linear improvement over time on both depression and wellbeing.

“For both PHQ-9 and WEMWBS, the fit of the slope change model was significantly greater than would have been expected by chance for seven out of eleven participants (P4, P6, P7, P8, P9, P11, P13), indicating significant linear improvement over time.”

May combine two claims.

This analysis meets the case series criterion for an intervention effect, although it is only considered moderate evidence as it was not demonstrated for each individual case.

“This analysis meets this criterion, although is only considered moderate evidence as it was not demonstrated for each individual case.”

May combine two claims.

Given high dropout rates in individual CBT for depression (estimated >25%), the retention rates in the case series are encouraging.

“Given high dropout rates in individual CBT for depression (estimated to be greater than 25%; Hans & Hiller, 2013;Fernandez, Salem, Swift & Ramtahal, 2015), the retention rates in the case series are encouraging.”

• cites Hans & Hiller, 2013Not checked yet

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• cites Fernandez, Salem, Swift & Ramtahal, 2015 sourceNot checked yet

  Not checked in the free run.

May combine two claims.

Visual inspection of mean effect sizes tentatively suggests ADepT outcomes were comparable to existing trials for depression, anxiety, and NVS outcomes, but potentially superior to existing trials for wellbeing, anhedonia and PVS outcomes.

“Visual inspection of mean effect sizes tentatively suggests ADepT outcomes were comparable to existing trials for depression, anxiety, and NVS outcomes, but potentially superior to existing trials for wellbeing, anhedonia and PVS outcomes.”

• Also stated in: § 4. Discussion · hedged

  “Visual inspection of mean effect sizes tentatively suggests ADepT outcomes were comparable to existing trials for depression, anxiety, and NVS outcomes, but potentially superior to existing trials for wellbeing, anhedonia and PVS outcomes.”

• AssumptionRests on an assumption: The benchmarking datasets (existing trials and routine IAPT service outcomes) are comparable to the ADepT case series in relevant characteristics (e.g., population, measures, setting).

May combine two claims.

This suggests better responses at the less severe end of the sample in the current version of the protocol and that some adaptations to the protocol may be required for severely depressed clients.

“While further evaluation is required, this suggests better responses at the less severe end of the sample in the current version of the protocol and that some adaptations to the protocol may be required for severely depressed clients.”

May combine two claims.

According to recent meta-analyses, a PHQ-9 score of 10 has 85% sensitivity and 89% specificity for diagnosing major depressive disorder, and a GAD-7 score of 8 has 83% sensitivity and 84% specificity for diagnosing generalized anxiety disorder.

“According to recent meta-analyses, a PHQ-9 score of 10 has 85% sensitivity and 89% specificity for diagnosing major depressive disorder (Manea, Gilbody, & McMillan, 2012) and a GAD-7 score of 8 has 83% sensitivity and 84% specificity for diagnosing generalized anxiety disorder (Plummer, Manea, Trepel, & McMillan, 2016).”

• cites Manea, Gilbody, & McMillan, 2012 sourceNot checked yet

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• cites Plummer, Manea, Trepel, & McMillan, 2016 sourceNot checked yet

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May combine two claims.

The one-year follow-up outcomes were not included in the repeated measures ANOVAs because this assessment was a post-hoc amendment to the protocol and data were only available for eight participants; including them would have significantly reduced statistical power.

“We did not include the one-year follow-up outcomes in the repeated measures ANOVAs as this assessment was a post-hoc amendment to the protocol and data were only available for eight participants.Including the one-year follow-up data in the ANOVA would have significantly reduced statistical power.”

May combine two claims.

Benchmarking analyses indicated that depression and anxiety mean effect-sizes in the case series were broadly comparable to those observed in existing CBT and BA trials and were superior to routine IAPT care.

“Benchmarking analyses indicated that depression and anxiety mean effect-sizes in the case series were broadly comparable to those observed in existing CBT and BA trials (e.g., DeRubeis et al., 2005;Hollon et al., 2014;Richards et al., 2016) and were superior to routine IAPT care (e.g., Zahra et al., 2014).”

• cites DeRubeis et al., 2005 sourceNot checked yet

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• cites Hollon et al., 2014 sourceNot checked yet

  Not checked in the free run.

• cites Richards et al., 2016Not checked yet

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May combine two claims.

Mean effect sizes for ADepT for PVS outcomes (anhedonia and positive affect) were larger than those found in previous trials of BA and CBT, suggesting ADepT has potential to lead to step-wise improvements in the capacity to treat PVS deficits.

“Mean effect sizes for ADepT for PVS outcomes (anhedonia and positive affect) were larger than those found in previous trials of BA and CBT (DeRubeis et al., 2005;Hollon et al., 2014;Richards et al., 2016), suggesting ADepT has potential to lead to step-wise improvements in the capacity to treat PVS deficits.”

• cites DeRubeis et al., 2005 sourceNot checked yet

  Not checked in the free run.

• cites Hollon et al., 2014 sourceNot checked yet

  Not checked in the free run.

• cites Richards et al., 2016Not checked yet

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May combine two claims.

There was preliminary but promising evidence of clinical effectiveness on the primary outcome measures, with triangulation in findings across analytic methods.

“There was preliminary but nevertheless promising evidence of clinical effectiveness on the primary outcome measures, with triangulation in findings across analytic methods.”

May combine two claims.

161 out of a possible 165 acute treatment sessions offered across clients were attended (98%; exceeding the 60% target).

“161 out of a possible 165 acute treatment sessions offered across clients were attended (98%; exceeding the 60% target).”

May combine two claims.

The sample are representative of patients seen in routine NHS care and comparable to those treated in existing trials used for benchmarking.

“They are therefore representative of patients seen in routine NHS care (e.g.Zahra et al., 2014) and comparable to those treated in existing trials that we used for benchmarking purposes (Richards et al., 2016;DeRubeis et al., 2005;Hollon et al., 2014).”

• cites Zahra et al., 2014Not checked yet

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• cites Richards et al., 2016Not checked yet

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• cites DeRubeis et al., 2005 sourceNot checked yet

  Not checked in the free run.

May combine two claims.

The small sample means that the effect sizes have wide confidence intervals and are likely to be positively biased, although Hedges small sample correction was used to minimize this.

“Fourth, the small sample means that the effect sizes have wide confidence intervals and are likely to be positively biased (although Hedges small sample correction was used to minimize this).”

May combine two claims.

The group level analyses were under-powered (as the intended completer sample size of 13 was not recruited) and no correction for multiple comparisons was made.

“Fifth, the group level analyses were under-powered (as we did not recruit the intended completer sample size of 13) and we did not correct for multiple comparisons as a result (to balance the risk between type I and type II error).”

May combine two claims.

The case series met all the continuation rules, indicating ADepT is ready to proceed to more rigorous evaluation via randomized controlled trial methodology.

“The case series met all the continuation rules, indicating ADepT is ready to proceed to more rigorous evaluation via randomized controlled trial methodology.”

Probably not a substantial claim: may not pass S2 (checkable).

On this basis, it seems valid to proceed to further evaluation of ADepT.

“On this basis, it seems valid to proceed to further evaluation of ADepT.”

May combine two claims.

The lead author was treatment developer, supervisor and one of the therapists, meaning there is potential for allegiance biases.

“First, the lead author was treatment developer, supervisor and one of the therapists, meaning that there is potential for allegiance biases.”

May combine two claims.

The present case series results clearly exceeded the liberal continuation rules, suggesting ADepT has potential to meet more stringent continuation rules in later development phases.

“It is noteworthy that the present case series results clearly exceeded these liberal continuation rules, suggesting ADepT has potential to meet more stringent continuation rules in later development phases.”

May combine two claims.

We did not exclude any eligible participants on the basis of the bereavement criteria in DSM-IV, meaning that our diagnoses align with those that would have been reached under DSM-V.

“We did not exclude any eligible participants on the basis of the bereavement criteria in DSM-IV, meaning that our diagnoses align with those that would have been reached under DSM-V.”

May combine two claims.

In summary, this case series provides preliminary evidence that ADepT is an acceptable intervention that is likely to lead to improvements in PVS and NVS and by doing so lead to enhanced wellbeing and reduced depression symptoms.

“In summary, this case series provides preliminary evidence that ADepT is an acceptable intervention to clients that is likely to lead to improvements in PVS and NVS and by doing so lead to enhanced wellbeing and reduced depression symptoms.”

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing). May combine two claims.

It may be that the PHQ-9 and the WEMWBS are not ideal measures of symptoms and positive recovery respectively and there is a need to develop better tools to measure these constructs.

“It may be that the PHQ-9 and the WEMWBS are not ideal measures of symptoms and positive recovery respectively and there is a need to develop better tools to measure these constructs.”

May combine two claims.

The time series slope analyses fitted a linear model of change during treatment, although visual inspection suggested a non-linear, variable pattern of change; this non-linearity would go against experimental predictions and inflate type II rather than type I error.

“Third, the time series slope analyses fitted a linear model of change during treatment (followed SMA guidance; Borckardt, 2006), although visual inspection of the data suggested a non-linear, variable pattern of change.The effect of this non-linearity would go against our experimental predictions (of a significant intervention effect), so will have inflated type II rather than type I error.”

• cites Borckardt, 2006Not checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S3 (load-bearing).

Treatment fidelity was not assessed (as no fidelity tool currently exists).

“Second, treatment fidelity was not assessed (as no fidelity tool currently exists).”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The case series protocol was not pre-registered, although data on all outcome measures collected using a variety of analytic procedures are reported, minimising risk of p- or measure-hacking.

“Finally, we did not pre-register the case series protocol (although we report data on all outcome measures collected using a variety of analytic procedures, therefore minimising risk of p-or measure-hacking).”

Probably not a substantial claim: may not pass S3 (load-bearing).

We did not capture the additional specifiers.

“However, we did not capture the additional specifiers.”

May combine two claims.

Across the board the group level analyses were all clearly significant for key comparisons, meaning it is very unlikely that this pattern would have emerged solely due to random error or inflated type I error.

“It is noteworthy that across the board the group level analyses were all clearly significant for key comparisons, meaning it is very unlikely that this pattern would have emerged solely due to random error or inflated type I error.”

May combine two claims.

The time series analyses on the primary outcome measures were adequately powered and were systematically replicated across a number of participants.

“Further, the time series analyses on the primary outcome measures were adequately powered and were systematically replicated across a number of participants.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

While post treatment quantitative and qualitative data suggested ADepT was acceptable and feasible, participants' views of the approach after their first treatment session were not captured.

“Eighth, while the post treatment quantitative and qualitative data suggested ADepT was acceptable and feasible, we did not capture participants'views of the approach after their first treatment session (for example, using the Credibility/Expectancy Questionnaire; Devilly & Borkovec, 2000).”

• cites Devilly & Borkovec, 2000 sourceNot checked yet

  Not checked in the free run.

May combine two claims.

There were no obvious differences in outcomes between therapists, preliminarily suggesting effects are not carried by particular therapists and that the protocol is likely generalizable to different workforces.

“There were no obvious differences in outcomes between therapists, preliminarily suggesting effects are not carried by particular therapists and that the protocol is likely generalizable to different workforces.”

Probably not a substantial claim: may not pass S3 (load-bearing).

DSM-IV rather than DSM-V instrumentation was used to assess depression.

“Sixth, DSM-IV rather than DSM-V instrumentation was used to assess depression.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Alternatively, it may be that wellbeing and depression are better viewed as opposite ends of a single underlying bipolar dimension (running from depression to neutral to wellbeing).

“Alternatively, it may be that wellbeing and depression are better viewed as opposite ends of a single underlying bipolar dimension (running from depression to neutral to wellbeing).”