Reducing Stasis Outcomes for Depression in Group Behavioural Activation Therapy
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|ClinicalTrials.gov Identifier: NCT02970279|
Recruitment Status : Completed
First Posted : November 21, 2016
Last Update Posted : May 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Behavioural Activation Group (BAG) Psychotherapy||Not Applicable|
A one-armed quasi-experimental trial will be used to test the effect of two embedded behavioural activation group (BAG) treatment augmentations on treatment outcomes and to identify a potential outcome mediator for patients with a stasis outcome. A non-randomised design enables data to be collected which reflects routine clinical practice and address stasis outcomes as they occur in real-world services. A matched pairs design will be implemented in the analysis to allow comparison of the enhanced BAG data with historical control data from archived outcomes of the existing treatment (i.e. the baseline data).
Patients who access the Improving Access to Psychological Therapies (IAPT) service in Sheffield, United Kingdom with a primary presenting problem of depression and are referred to BAG will be approached to take part in the study. Patients will be asked to provide informed consent to agree for their weekly routine outcome scores from enhanced BAG to be used in the study.
Enhanced BAG Augmentations
The existing BAG treatment will be enhanced with embedded treatment augmentations. The augmentations will consist of two strands; 1) implementation intentions to directly target reducing stasis and 2) psychoeducation to target reducing drop-out.
Implementation Intentions: The first augmentation will be a top-down theoretically informed 'implementation intentions' enhancement to target reducing the stasis outcome rate. Implementation intentions are specific plans about how, when and where goals will be acted upon, formed using an if-then format in order to effectively implement actions. Patients will be taught to use if-then planning (implementation intentions) to help them complete the between-session which is crucial to producing change in BA.
Dose-Response Psychoeducation: The second augmentation will be a dose-response psychoeducation enhancement aimed at reducing the dropout rate. Patients will be given information based on practice-based evidence about the effectiveness of BAG and dose-response information (minimum number of sessions required to experience change).
Treatment adherence to the protocol will be assessed using a BAG adherence checklist created for this trial. Adherence will be checked and compared using self-report and an expert rater; i) after each session the BAG facilitators will complete the session integrity measure to check self-report adherence and ii) the BAG facilitator lead will observe and rate one session from each course of BAG to provide an expert adherence check.
Data collection for the study will run for a year from January 2017 until December 2017 incorporating six BAG treatment groups.
The data will be analysed using the intention-to-treat (ITT) principle. The final available measure will be used as the post score or if there is only one score available, it will be assumed there was no change. Patients who do not score above the clinical cut-off for depression (score of ≥10 on Patient Health Questionnaire [PHQ-9]) prior to commencing BAG will not be included in the analysis to avoid a floor effect when calculating stasis outcomes.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Treatment Augmentations Embedded in Behavioural Activation Group Therapy on Reducing Drop-out and Stasis Rates in Depression|
|Study Start Date :||December 2016|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Experimental: Enhanced Behavioural Activation Groups
Behavioural activation group (BAG) psychotherapy delivered with two embedded treatment augmentations;
Behavioral: Behavioural Activation Group (BAG) Psychotherapy
Behavioural activation (BA) is a psychotherapy intervention based on behaviour theory and operant conditioning. It teaches patients to reduce avoidant depressive behaviours and in turn increase the positive reinforcement they receive from their environment for non-depressive behaviours through the use of activity scheduling and pleasant events. For the trial, BA will be delivered in a group format (BAG) and facilitated by two therapists. BAG treatment will consist of eight weekly sessions, lasting two hours and will follow a manualised treatment protocol. Each session will be based on a different topic relevant to the principles of BA and patients will be given between session work to complete to encourage increased participation in rewarding personally meaningful activities.
- Change in Patient Health Questionnaire (PHQ-9) scores [ Time Frame: Week 1 (pre-treatment), at every weekly treatment session attended (for 8 weeks) and at week 8 (end of treatment) ]Validated 9-item self-report measure of depressive symptoms
- Patient attendance at treatment sessions [ Time Frame: Weeks 1-8 (every weekly treatment session - maximum of 8) ]Number of therapy sessions patients attend in a course of treatment
- Change in Valued Living Questionnaire (VLQ) score [ Time Frame: Week 1 (pre-treatment), week 4 (at the 4th treatment session) and at week 8 (end of treatment) ]Validated self-report measure of engagement in valued living
- Change in Generalised Anxiety Disorder Assessment (GAD-7) score [ Time Frame: Week 1 (pre-treatment), at every weekly treatment session attended (for 8 weeks) and at week 8 (end of treatment) ]Validated 7-item self-report measure of anxiety symptoms
- Change in Work and Social Adjustment Scale (WSAS) score [ Time Frame: Week 1 (pre-treatment), at every weekly treatment session attended (for 8 weeks) and at week 8 (end of treatment) ]Validated self-report measure of functional impairment as a result of mental health problems
- Behavioural activation group (BAG) therapy adherence [ Time Frame: Weeks 1-8 (Every treatment session) ]BAG facilitators will complete an therapy adherence checklist (designed for this trial) after each session. An external rater will rate one session of each course of treatment to ensure adherence to the treatment protocol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970279
|Sheffield Health and Social Care NHS Foundation Trust - Improving Access to Psychological Therapies Service|
|Sheffield, South Yorkshire, United Kingdom, S3 7ND|
|Principal Investigator:||Melanie K Simmonds-Buckley, BSc||University of Sheffield|
|Principal Investigator:||Stephen Kellett, DClinPsy||University of Sheffield & Sheffield Health and Social Care NHS Foundation Trust|
|Principal Investigator:||Glenn Waller, PhD||University of Sheffield|