Moderators and mediators of emotion regulation therapy for psychologically distressed caregivers of cancer patients: secondary analyses from a randomized controlled trial.

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

In an RCT of 20-session ERT versus an attention control for generalized anxiety disorder with or without depression, all four proposed mediators showed indirect effects on all primary outcomes.

“In an RCT investigating the efficacy of 20 sessions of ERT compared with an attention control condition in the treatment of generalized anxiety disorder with and without depression, all four proposed mediators (mindfulness, emotion dysregulation, decentering, and cognitive reappraisal) showed an indirect effect on all primary outcomes [14].”

• cites [14] sourceSupported

May combine two claims.

In a prior randomized controlled trial, Emotion Regulation Therapy for caregivers reduced psychological distress, worry, and perceived caregiver burden in psychologically distressed informal caregivers of cancer patients.

“We have recently, in a randomized controlled trial (RCT), demonstrated efficacy of Emotion Regulation Therapy for caregivers (ERT-C), evidenced as lower levels of psychological distress.”

• Also stated in: § Background · plain

  “In the RCT, we randomized 81 psychologically distressed ICs to ERT-C or a waitlist. ICs in the ERT-C group experienced significant reductions in psychological distress, worry, and perceived caregiver burden (Hedges’ g: 0.53-0.96) following the course of 8 sessions [12].”

• Also stated in: § Conclusions · plain

  “ERT-C has received empirical support for its efficacy in treating ICs of cancer patients.”

• cites [12] sourceSupported

Classified as probably not a substantial claim.

Participants were randomly allocated to ERT-C or a waitlist condition.

“Upon having provided written informed consent, ICs were randomly allocated to either the ERT-C or a waitlist condition as described in the previous publication establishing the efficacy of ERT-C (11).”

• cites [11] sourceCould not verify

  The Study Population section describes a random sample of Medicare couples, and Statistical analysis describes observational analyses of spousal hospitalization and mortality. Searches for ERT-C, a waitlist, and random allocation found no passage about the claimed intervention assignment. (LLM, conf=0.78)

  Experimental — accuracy not yet measured

May combine two claims.

In a meta-analysis of CBT trials, younger samples and samples with a larger proportion of women obtained larger treatment effects, with age and proportion of female participants significantly associated with effect magnitude.

“In the meta-analysis mentioned above [18], age (B=−0.02, p=0.046) and proportion of female participants (B=0.01, p=0.001) were significantly associated with the magnitude of the treatment effect. Specifically, younger samples and samples with a larger proportion of women obtained larger effects”

• cites [18] sourceSupported

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

Homework is an integral part of most contemporary CBTs, based on the premise that new skills are best acquired and consolidated through everyday practice.

“homework is an integral part of most contemporary CBTs, rooted in the premise that new skills are best acquired and consolidated through training in everyday life [20]”

• cites [20] sourceCould not verify

  The “CBT Principles and Processes That Promote Behavioral Adaptation” and “Context Engagement” sections discuss enacting new experiences and learning adaptive responses, but do not say that homework is integral to most CBTs or that everyday practice is how new skills are best acquired and consolidated. Searches for “homework” and for everyday practice and skill consolidation found no passage addressing that claim. (LLM, conf=0.70)

  Experimental — accuracy not yet measured

Classified as probably not a substantial claim.

Greater practice of regulatory skills following mindfulness treatment is associated with increases in decentering.

“a recent empirical study showing that greater practice of regulatory skills following mindfulness treatment was associated with increases in decentering”

• cites [21] sourcePartly supported

  The introduction (p. 2) reports that mindfulness-based cognitive therapy produced larger increases in decentering than treatment as usual. It does not report that greater practice of regulatory skills following treatment was associated with those increases; that practice–decentering association is unsupported. (LLM, conf=0.84)

  Experimental — accuracy not yet measured
• cites [22] sourcePartly supported

  The ‘Decentering and metacognitive awareness’ section (page unavailable) reports that increases in mindfulness during interventions were associated with increases in a decentering-related measure. It does not report that greater practice of regulatory skills following treatment was associated with increased decentering; it reviews other studies rather than presenting the described empirical study. (LLM, conf=0.86)

  Experimental — accuracy not yet measured

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

Treatment was delivered by twelve master's or doctorate level students with good manual fidelity.

“Twelve master’s or doctorate level students delivered the treatment and showed good manual fidelity [see 12].”

• cites [12] sourceSupported

Classified as probably not a substantial claim.

In an open trial of ERT in young adults, changes in decentering and cognitive reappraisal temporally preceded changes in anxiety symptoms.

“In an open trial of ERT in a sample of young adults, changes in decentering and cognitive reappraisal were found to temporally precede changes in two and three measures of anxiety symptoms, respectively [26].”

• cites [26] sourceSupported

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

It has been theoretically argued and empirically documented that attention regulation change precedes metacognitive regulation change because decentering relies on attention and mindful awareness.

“it has been theoretically argued and empirically documented, that attention regulation change precedes metacognitive regulation change because decentering, for instance, inherently relies on the individual paying attention to and being mindfully aware of their experience [22,46].”

• cites [22] sourcePartly supported

  In “Decentering and metacognitive awareness” (page unavailable), the paper says decentering entails observing subjective experience and reports that increases in mindfulness were related to increases in disidentification. It presents the proposed relationship as a hypothesis that the studies begin to test; it does not document that attention-regulation change temporally precedes metacognitive-regulation change. (LLM, conf=0.86)

  Experimental — accuracy not yet measured
• cites [46]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

There was a bidirectional temporal relation between decentering and worry, partly replicating past ERT trial findings.

“We further tested the proposed mediators’ temporal relation to the outcomes and found a bidirectional relation between decentering and worry. Changes in decentering preceded changes in worry and vice versa, thus partly replicating past ERT trial findings [26].”

• Also stated in: § Conclusions · plain

  “In terms of timeline of change, changes in decentering preceded changes in worry and vice versa.”

• cites [26] sourceSupported

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

In the analyzed sample, the mean age was 47.9 years and most participants were female.

“The mean age of the IC sample was 47.9 years. Most ICs were female (75%) caring for male patients (73%), primarily with stage IV cancer (58%), diagnosed primarily with colon cancer (25%).”

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

Average homework completion during treatment was 3.4 on a 1-to-5 scale.

“During treatment, the average homework completion was 3.4 (scale from 1 to 5).”

May combine two claims.

Homework compliance did not significantly moderate worry or perceived burden, although both effects were in the same direction and small.

“This pattern of results was not the case for worry (F=2.0, p=.164, d=.17) or perceived burden (F=2.7, p=.099, d=.21), although both in the same direction and of a small magnitude.”

May combine two claims.

In a combined model for worry, only decentering remained significant, not mindfulness or emotion regulation.

“In a combined model, only decentering remained significant (Z=−2.52, p=.012, r=.31), not mindfulness (Z=−1.27, p=.204, r=.16) or emotion regulation (Z=−0.87, p=.382, r=.11).”

May combine two claims. The quote only partly states this claim.

Changes in worry temporally preceded changes in decentering, with a similar magnitude to the reverse direction.

“however, the reverse direction was also significant (Z=2.17, p=.030, r=.27) and of a similar magnitude.”

May combine two claims.

In a combined model for perceived burden, only emotion regulation remained significant, not mindfulness or decentering.

“In a combined model, only emotion regulation remained significant (Z=−2.72, p=.006, r=.34), not mindfulness (Z=−0.29, p=.863, r=.02) or decentering (Z=−0.67, p=.501, r=.08).”

Classified as probably not a substantial claim.

Meta-analyses have documented elevated anxiety and depression in informal caregivers of cancer patients.

“Meta-analyses have documented elevated levels of psychological distress expressed as anxiety and depression in ICs [2,3]”

• cites [2] sourceNot checked — no full text of the source
• cites [3] sourceNot checked — no full text of the source

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

Meta-analytic evidence shows that homework enhances overall treatment outcome in CBTs.

“meta-analytic evidence showing that homework enhances overall treatment outcome in CBTs [23,24]”

• cites [23] sourceNot checked — no full text of the source
• cites [24] sourceNot checked — no full text of the source

May combine two claims.

Twenty-nine informal caregivers (36%) dropped out, 23 during treatment; dropouts were significantly older and less worried at pretreatment than completers.

“Twenty-nine ICs (36%) dropped out, 23 during treatment. Treatment dropouts were statistically significantly older (mean age=52.7 years) than completers (mean=45.3years; p=.034) and worried less at pretreatment (p=.026).”

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

The study was pre-registered at Clinicaltrials.gov under identifier NCT02322905.

“The study was pre-registered at Clinicaltrials.gov (#NCT02322905).”

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

Missing observations averaged 11.5% across the eight time points.

“Missing observations for each of the time points averaged to 11.5%: Session 1=0%, session 2=0%, session 3=11%, session 4=15%, session 5=17%, session 6=18%, session 7=20%, session 8=11%.”

May combine two claims.

A majority of females in the sample and an uneven dropout rate by age limit the moderation analyses concerning gender and age.

“Finally, a majority of females in the included sample, and an uneven dropout rate in terms of age, limit the moderation analyses concerning gender and age.”

May combine two claims.

The relatively low number of participants threatens generalizability and statistical power, though the ability to detect small-to-medium effects as statistically significant partly alleviates the power concern.

“Second, the relatively low number of participants poses a threat both to generalizability and to the statistical power. Our ability to detect effect sizes of small to medium magnitudes as statistically significant partly alleviates the latter concern.”

May combine two claims.

The moderation analyses of age and gender revealed negligible to small effects, suggesting that females may experience a larger decrease in worry and younger participants may experience a larger decline in burden.

“The moderation analyses of age and gender revealed negligible to small effects, suggesting that females may experience a larger decrease in worry, and that younger participants may experience a larger decline in burden.”

May combine two claims.

The validity of the age and gender moderation analyses may be threatened by the majority of participants being female and by dropouts being older.

“However, the validity of the moderation analyses concerning age and gender may be threatened by the majority of participants included in the present study being female and by dropouts being of older age.”

Classified as probably not a substantial claim.

The high correlations between proposed mediators could point to between-measures overlap.

“which could point to between-measures overlap.”

May combine two claims.

The finding of a bidirectional temporal relation between decentering and worry needs replication but is an important step in understanding the causal pathway to lowering worry.

“This finding needs to be replicated but is an important step in understanding the causal pathway to lowering worry.”

May combine two claims.

Correlation-based mediation analyses generally supported the ERT model, with all proposed mediators except cognitive reappraisal consistently showing significant indirect effects on outcomes.

“Correlational mediation analyses generally supported the ERT model.”

• Also stated in: § Discussion · plain

  “All but cognitive reappraisal consistently showed significant indirect effects on outcomes, thus being in support of the underlying ERT model [16].”

• Also stated in: § Conclusions · plain

  “Correlation-based mediation analyses provided general support for the ERT model.”

• cites [16] Mennin DS, 2015Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Most analyses were correlational, preventing causal interpretation, and only one significant finding was detected in analyses taking the timeline of change into account.

“First, most analyses were based on a correlational approach (i.e., products-of-coefficients) preventing causal interpretation, and only one significant finding was detected in analyses taking the timeline of change into account.”

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

The results underscore the benefits to cancer patients of addressing informal caregiver distress and the necessity to consider caregivers as key members of treatment teams.

“Finally, our results underscore the benefits to cancer patients of addressing IC distress, and more broadly the necessity to consider caregivers as key members of treatment teams.”

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

The number of analyses conducted increased the risk of a type-I error, so the results should be replicated in future trials to ensure robustness.

“Given the number of analyses conducted, thereby increasing the risk of a type-I error, these results should be replicated in future trials to ensure their robustness.”

May combine two claims.

In the informal caregiver population, the temporal relation between decentering and worry may or may not be specific to ERT-C, but the results are promising in that they elucidate a potential causal pathway to lowering worry.

“In the IC population, this temporal relation between decentering and worry may or may not be specific to ERT-C, but the results are promising in that they elucidate a potential causal pathway to lowering worry.”