Unguided low intensity cognitive behaviour therapy for anxiety and depression during the COVID-19 pandemic: A randomised trial

The quote only partly states this claim.

In adults in Australia and the UK during the COVID-19 pandemic, unguided low intensity CBT produced a small significant reduction in anxiety compared with a waitlist control after one week, with d = 0.36 [0.18, 0.54].

“The intervention group demonstrated significant decreases in anxiety (d = 0.36 [0.18, 0.54]) and depression (d = 0.28 [0.11, 0.45]) compared to controls.”

• Also stated in: § Changes over time · plain

  “After accounting for pre-treatment levels, the control group had significantly higher anxiety on the GAD-7 following treatment compared to the intervention group, which was a small effect (d = 0.36 [0.18, 0.54]; see Table 5 for coefficients).”

• AssumptionRests on an assumption: Participants in the waitlist control group did not receive the intervention or other active mental health treatment during the one-week wait.

The quote only partly states this claim.

In adults in Australia and the UK during the COVID-19 pandemic, unguided low intensity CBT produced a small significant reduction in depressive symptoms compared with a waitlist control after one week, with d = 0.28 [0.11, 0.45].

“The intervention group demonstrated significant decreases in anxiety (d = 0.36 [0.18, 0.54]) and depression (d = 0.28 [0.11, 0.45]) compared to controls.”

• Also stated in: § Changes over time · plain

  “Similarly, after controlling for pre-treatment levels, the control group also had a significantly higher level of depressive symptoms following treatment compared to the intervention group, and this was a small effect (d = 0.28 [0.11, 0.45]; see Table 5 for coefficients).”

• AssumptionRests on an assumption: Participants in the waitlist control group did not receive the intervention or other active mental health treatment during the one-week wait.

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

Most participants agreed the guide was easy to read (83% in the abstract; 86% in the results).

“with 83% agreeing the intervention was easy to read”

• Also stated in: § Adherence to treatment and guide feedback · plain

  “Most of the sample (86%) either agreed or strongly agreed that the guide was easy to read”

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

When asked about preferred format, 46% of participants preferred a mobile app, 38% a paper copy, and 56% a website.

“When asked about their preferred format(s) for the intervention, 37 (46%) of participants would prefer to receive it as a mobile app, 31 (38%) as a paper copy, and 45 (56%) through a website online.”

May combine two claims.

The anxiety treatment effect was not moderated by pre-treatment anxiety or age.

“While pre-treatment levels of anxiety were significantly positively associated with post-treatment severity, there was no moderation on the treatment effect. There was also no direct or moderating relationship from age.”

May combine two claims.

Among intervention completers who provided feedback, 88% read 50% or more of the guide and 57% read the full guide.

“Of the participants who completed the intervention and provided feedback (n = 81), 71 (88%) indicated they had read 50% or more of the guide, with 46 (57%) reporting that they had read the full guide.”

May combine two claims.

The final sample was 225 participants (193 from Australia, 32 from the UK), with 112 randomly allocated to the intervention group and 113 to the waitlist group.

“The final sample was 225 participants (193 from Australia, 32 from the UK), of which 112 participants were randomly allocated to the intervention group, and 113 to the waitlist group.”

May combine two claims.

Most participants (62%) preferred no guidance, while 20% reported they would have liked guidance.

“When asked about if they would have benefited from receiving personal guidance, most participants (62%) said they preferred no guidance, with 20% reporting they would have liked guidance.”

May combine two claims.

At pre-treatment, about 35% of the intervention group and 36% of the control group had moderate to severe anxiety, and about 36% and 42% respectively had moderate to severe depressive symptoms.

“At pre-treatment, 34.8% of the intervention group and 36.3% of the control group had a GAD-7 score ≥10, indicating moderate to severe anxiety. Similarly, 35.7% of the intervention group and 41.6% of the control group presented with a PHQ-9 score ≥10, indicating moderate to severe depressive symptoms.”

May combine two claims.

Completers and non-completers did not differ significantly in baseline PHQ-9, GAD-7, or age; dropouts were all female, a significant gender difference.

“There were no significant differences in PHQ-9 (p = .232), GAD-7 (p = .090), or age (p = .896). There was a significant difference in gender (p = .037), with all participants who dropped out identifying as female.”

May combine two claims.

UK residence had no significant main or moderating effect on GAD-7 or PHQ-9 outcomes.

“Although UK residents had higher mean GAD-7 and PHQ-9 scores, there were no significant main or moderating effects of UK residence”

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

Of the 318 individuals who consented and were screened for suicide risk, 28% were not included in the trial due to moderate to high suicide risk.

“Of the 318 individuals who consented and were screened for suicide risk, 28% were not included in the trial due to moderate to high suicide risk.”

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

There was 23.11% loss to follow-up, with 25.00% in the intervention group and 21.24% in the control group.

“There was no missing data at baseline, and a 23.11% loss to follow-up (Intervention: 25.00%, Control: 21.24%).”

Classified as probably not a substantial claim.

Missing data were handled using full-information maximum-likelihood.

“Missing data were accounted for using full-information maximum-likelihood.”

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

Statistical analysis was performed by a statistician external to the trial who analysed the data blind to treatment condition.

“Statistical analysis was performed by a statistician external to the trial (AJ), who analysed the data blind to treatment condition.”

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

Randomisation was conducted using an embedded randomiser within the survey software.

“Randomisation was conducted using an embedded randomiser within the survey software.”

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

The trial was registered on the Australian New Zealand Clinical Trials Registry before it was conducted.

“The study was a randomised controlled trial and registered on the Australian New Zealand Clinical Trails Registry on 30 July 2020 (ACTRN12620000779976p).”

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

Low-intensity cognitive behaviour therapy is a scalable intervention that could be widely disseminated during the pandemic.

“Low-intensity Cognitive Behaviour Therapy (CBT) is a scalable intervention which could be widely disseminated during the pandemic, and is defined as a CBT intervention which utilises self-help materials as either unguided or guided interventions, with no more than 6 h of guidance (Shafran et al., 2021).”

• cites Shafran et al., 2021 sourceNot checked yet

  Not checked in the free run.

May combine two claims.

The UK's wide-scale roll-out of low-intensity CBT through the IAPT scheme demonstrated effectiveness and significant cost savings to the health system.

“The successful wide-scale roll-out of low-intensity CBT in the UK through the Increasing Access to Psychological Therapies (IAPT) scheme has demonstrated effectiveness, as well as significant cost savings to the health system (Clark, 2018).”

• cites Clark, 2018 sourceNot checked yet

  Not checked in the free run.

May combine two claims.

The proportions with moderate to severe anxiety or depressive symptoms in this sample were markedly larger than those in a UK COVID-19 population and pre-COVID community norms.

“These proportions are markedly larger than those seen by Fancourt et al. (2020) in a UK population assessed during COVID-19, who reported 22.6% and 25% of their sample presenting with moderate to severe anxiety or depressive symptoms, respectively. Similarly, and perhaps unsurprisingly, these proportions are also markedly larger than pre-COVID community norms on the PHQ-9 (5.6%; Kroenke et al., 20”

• cites Fancourt et al., 2020Not checked yet

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• cites Kroenke et al., 2001 sourceNot checked yet

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• cites Löwe et al., 2008Not checked yet

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

The intervention had a Flesch-Kincaid grade point reading level of 11.

“The Flesch-Kincaid grade point reading level was 11, understandable by a high school student”

May combine two claims.

Standard CBT and pandemic-specific materials were combined, so the design could not evaluate the separate contribution of each.

“A final limitation of the study was that standard CBT and pandemic-specific materials were combined together, hence the design did not allow evaluation of the extent to which standard CBT materials or pandemic-specific materials contributed to the observed effects.”

May combine two claims.

The sample was on average in a clinical range of anxiety and depression, demonstrating the need for interventions during the pandemic.

“Our sample were on average in a clinical range of anxiety and depression, demonstrating the need for interventions to be available during the pandemic.”

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

The study was approved by the Curtin University Human Research Ethics Committee.

“The study was approved by the Curtin University Human Research Ethics Committee (HRE2020-0424).”

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

In Australia, a survey of 1296 adults found elevated anxiety (GAD-7 M = 4.4) and depression (PHQ-9 M = 5.4) compared with population norms, similar to UK rates.

“In Australia, Dawel et al. (2020) conducted a survey of 1296 adults, and found elevated anxiety on the Generalised Anxiety Disorder questionnaire (GAD-7; Spitzer et al., 2006) (M = 4.4) and depression on the Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001) (M = 5.4) compared to population norms, similar to rates seen in the UK (GAD-7, M = 5.7; PHQ-9, M = 6.6; Fancourt et al., 2020).”

• cites Dawel et al., 2020 sourceNot checked yet

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• cites Fancourt et al., 2020Not checked yet

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

The PHQ-9 had excellent internal consistency in the current study (α = .87).

“in the current study internal consistency was excellent (α = .87).”

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

COVID-19 is increasing exponentially in many regions, with documented negative mental health impacts in the United States, India, and Europe.

“COVID-19 is increasing exponentially in many regions, with documented negative mental health impacts in the United States (e.g., Fitzpatrick et al., 2020), India (e.g., Verma & Mishra, 2020) and Europe (e.g., Gonzalez-Sanguino et al., 2020).”

• cites Fitzpatrick et al., 2020 sourceNot checked yet

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• cites Verma & Mishra, 2020 sourceNot checked yet

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• cites Gonzalez-Sanguino et al., 2020Not checked yet

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

Pandemic-specific concerns in the intervention were selected based on the literature and the researchers' clinical judgement.

“pandemic specific concerns (e.g., isolation, homeschooling, unemployment) were selected based on the literature which had raised these areas as concerns in surveys during the pandemic (e.g., Dawel et al., 2020) and the researchers’ clinical judgement regarding what areas may be impacted during the pandemic.”

• cites Dawel et al., 2020 sourceNot checked yet

  Not checked in the free run.

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based). May combine two claims.

The intervention was suitable for higher income countries such as the UK and Australia, and work is needed in lower- and middle-income countries.

“Fourth, the intervention was suitable to higher income countries such as the UK and Australia, work is needed in lower-and-middle income countries to evaluate scalable interventions to mitigate the mental health impacts of the pandemic throughout the world.”

May combine two claims.

The study had no follow-up period, so the durability of reductions in anxiety and depression could not be determined.

“First, there was no follow-up period, therefore it is not possible to determine if the reductions in anxiety and depression were durable.”

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

A sharp and rapid increase in mental health symptoms is occurring globally due to the pandemic.

“This is particularly pertinent in the current situation where a sharp and rapid increase in mental health symptoms is occurring globally due to the pandemic (Xiong et al., 2020).”

• cites Xiong et al., 2020 sourceNot checked yet

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

The GAD-7 had excellent internal consistency in the current study (α = .90).

“in the current study internal consistency was excellent (α = .90).”

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

Recent studies with over 17,000 people in the UK and over 300,000 people in the US found significantly increased rates of anxiety and depression during the pandemic compared with pre-COVID-19.

“Recent studies with over 17,000 people in the United Kingdom (UK) (Pierce et al., 2020) and over 300,000 people in the United States (US) (Twenge & Joiner, 2020) found significantly increased rates of anxiety and depression during the pandemic compared to pre COVID-19.”

• cites Pierce et al., 2020 sourceNot checked yet

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• cites Twenge & Joiner, 2020 sourceNot checked yet

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