Dataset Information

Cognitive-behavioural versus cognitive-analytic guided self-help for mild-to-moderate anxiety: a pragmatic, randomised patient preference trial.

ABSTRACT:

Background

Guided self-help (GSH) for anxiety is widely implemented in primary care services because of service efficiency gains, but there is also evidence of poor acceptability, low effectiveness and relapse.

Aims

The aim was to compare preferences for, acceptability and efficacy of cognitive-behavioural guided self-help (CBT-GSH) versus cognitive-analytic guided self-help (CAT-GSH).

Method

This was a pragmatic, randomised, patient preference trial (Clinical trials identifier: NCT03730532). The Beck Anxiety Inventory (BAI) was the primary outcome at 8- and 24-week follow-up. Interventions were delivered competently on the telephone via structured workbooks over 6-8 (30-35 min) sessions by trained practitioners.

Results

A total of 271 eligible participants were included, of whom 19 (7%) accepted being randomised and 252 (93%) chose their treatment. In the preference cohort, 181 (72%) chose CAT-GSH and 71 (28%) preferred CBT-GSH. BAI outcomes in the preference and randomised cohorts did not differ at 8 weeks (-0.80, 95% confidence interval (CI) -4.52 to 2.92) or 24 weeks (0.85, 95% CI -2.87 to 4.57). After controlling for allocation method and baseline covariates, there were no differences between CAT-GSH and CBT-GSH at 8 weeks (F(1, 263) = 0.22, P = 0.639) or at 24 weeks (F(1, 263) = 0.22, P = 0.639). Mean BAI change from baseline was a reduction of 9.28 for CAT-GSH and 9.78 for CBT-GSH at 8 weeks and 12.90 for CAT-GSH and 12.43 for CBT-GSH at 24 weeks.

Conclusions

Patients accessing routine primary care talking treatments prefer to choose the intervention they receive. CAT-GSH expands the treatment offer in primary care for patients with anxiety seeking a brief but analytically informed GSH solution.

SUBMITTER: Kellett S

PROVIDER: S-EPMC10895510 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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Publications

Cognitive-behavioural versus cognitive-analytic guided self-help for mild-to-moderate anxiety: a pragmatic, randomised patient preference trial.

Kellett Stephen S Bee Charlotte C Smithies Jess J Aadahl Vikki V Simmonds-Buckley Melanie M Power Niall N Dugen-Williams Caroline C Fallon Neil N Delgadillo Jaime J

The British journal of psychiatry : the journal of mental science 20230901 3

<h4>Background</h4>Guided self-help (GSH) for anxiety is widely implemented in primary care services because of service efficiency gains, but there is also evidence of poor acceptability, low effectiveness and relapse.<h4>Aims</h4>The aim was to compare preferences for, acceptability and efficacy of cognitive-behavioural guided self-help (CBT-GSH) versus cognitive-analytic guided self-help (CAT-GSH).<h4>Method</h4>This was a pragmatic, randomised, patient preference trial (Clinical trials identi ...[more]

PMID: 37395600

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Project description:BackgroundDepression has serious personal, family and economic consequences. It is estimated that it will cost £12.15 billion to the economy each year in England by 2026. Improving access to psychological therapies (IAPT) is the National Health Service talking therapies service in England for adults experiencing anxiety or depression. Over 1 million people are referred to IAPT every year, over half experiencing depression. Where symptoms of depression are mild to moderate, people are typically offered cognitive behavioural therapy (CBT) self-help (CBT-SH) supported by a psychological well-being practitioner. The problem is that over half of people who complete treatment for depression in IAPT remain depressed despite receiving National Institute of Health and Care Excellent recommended treatment. Furthermore, less than half of IAPT service users complete treatment. This study seeks to investigate the effectiveness of an alternative to CBT-SH. Mindfulness-based cognitive therapy (MBCT) differs from CBT in focus, approach and practice, and may be more effective with a higher number of treatment completions.Methods/designThis is a definitive randomised controlled trial comparing supported MBCT self-help (MBCT-SH) with CBT-SH for adults experiencing mild to moderate depression being treated in IAPT services. We will recruit 410 participants experiencing mild to moderate depression from IAPT services and randomise these to receive either an MBCT-based self-help workbook or a CBT-based self-help workbook. Participants will be asked to complete their workbook within 16 weeks, with six support sessions with a psychological well-being practitioner. The primary outcome is depression symptom severity on treatment completion. Secondary outcomes are treatment completion rates and measures of generalized anxiety, well-being, functioning and mindfulness. An exploratory non-inferiority analysis will be conducted in the event the primary hypothesis is not supported. A semi-structured interview with participants will guide understanding of change processes.DiscussionIf the findings from this randomised controlled trial demonstrate that MBCT-SH is more effective than CBT-SH for adults experiencing depression, this will provide evidence for policy makers and lead to changes to clinical practice in IAPT services, leading to greater choice of self-help treatment options and better outcomes for service users. If the exploratory non-inferiority analysis is conducted and this indicates non-inferiority of MBCT-SH in comparison to CBT-SH this will also be of interest to policy makers when seeking to increase service user choice of self-help treatment options for depression.Trial registrationCurrent Controlled Trial registration number: ISRCTN 13495752. Registered on 31 August 2017 (www.isrctn.com/ISRCTN13495752).

Project description:ObjectiveTo determine if guided internet based cognitive behavioural therapy with a trauma focus (CBT-TF) is non-inferior to individual face-to-face CBT-TF for mild to moderate post-traumatic stress disorder (PTSD) to one traumatic event.DesignPragmatic, multicentre, randomised controlled non-inferiority trial (RAPID).SettingPrimary and secondary mental health settings across the UK's NHS.Participants196 adults with a primary diagnosis of mild to moderate PTSD were randomised in a 1:1 ratio to one of two interventions, with 82% retention at 16 weeks and 71% retention at 52 weeks. 19 participants and 10 therapists were purposively sampled and interviewed for evaluation of the process.InterventionsUp to 12 face-to-face, manual based, individual CBT-TF sessions, each lasting 60-90 minutes; or guided internet based CBT-TF with an eight step online programme, with up to three hours of contact with a therapist and four brief telephone calls or email contacts between sessions.Main outcome measuresPrimary outcome was the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at 16 weeks after randomisation (diagnosis of PTSD based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, DSM-5). Secondary outcomes included severity of PTSD symptoms at 52 weeks, and functioning, symptoms of depression and anxiety, use of alcohol, and perceived social support at 16 and 52 weeks after randomisation.ResultsNon-inferiority was found at the primary endpoint of 16 weeks on the CAPS-5 (mean difference 1.01, one sided 95% confidence interval -∞ to 3.90, non-inferiority P=0.012). Improvements in CAPS-5 score of more than 60% in the two groups were maintained at 52 weeks, but the non-inferiority results were inconclusive in favour of face-to-face CBT-TF at this time point (3.20, -∞ to 6.00, P=0.15). Guided internet based CBT-TF was significantly (P<0.001) cheaper than face-to-face CBT-TF and seemed to be acceptable and well tolerated by participants. The main themes of the qualitative analysis were facilitators and barriers to engagement with guided internet based CBT-TF, treatment outcomes, and considerations for its future implementation.ConclusionsGuided internet based CBT-TF for mild to moderate PTSD to one traumatic event was non-inferior to individual face-to-face CBT-TF and should be considered a first line treatment for people with this condition.Trial registrationISRCTN13697710.

Dataset Information

Cognitive-behavioural versus cognitive-analytic guided self-help for mild-to-moderate anxiety: a pragmatic, randomised patient preference trial.

Background

Aims

Method

Results

Conclusions

Publications

Cognitive-behavioural versus cognitive-analytic guided self-help for mild-to-moderate anxiety: a pragmatic, randomised patient preference trial.

Similar Datasets

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