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临床试验/NCT02970279
NCT02970279已完成不适用

Effect of Treatment Augmentations Embedded in Behavioural Activation Group Therapy on Reducing Drop-out and Stasis Rates in Depression

University of Sheffield2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2016年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Change in Patient Health Questionnaire (PHQ-9) scores

研究概览

简要总结

Depression is one of the most common mental health disorders and it is estimated up to 50% of patients do not respond to evidenced-based psychotherapy treatment, recording a 'stasis' outcome. However, there is limited research understanding this population, meaning a considerable number of people continue to suffer. The purpose of this study is to 1) identify depression stasis prevalence and predictors in an existing evidenced-based group treatment for depression, 2) run a clinical trial to test whether an embedded intervention based on theoretical and clinical practice evidence can help reduce patient depression stasis and drop-out rates and 3) understand what aspect of therapy produces change (or prevents change in stasis). The study will be based on behavioural activation (BA) therapy delivered in an eight-session group format in an Improving Access to Psychological Therapies (IAPT) service in the United Kingdom. BA is one of the most effective psychotherapies available for depression and focuses on helping patients to increase their engagement with valued activities to help break out of the cycle of depression. Firstly, an archived anonymised dataset of routine depression measures from patients who have previously received the existing group BA treatment will be analysed. Secondly, the group BA treatment delivered to patients in 2017 will be enhanced with two treatment augmentations. One augmentation will target stasis outcomes through the addition of specific 'if-then' planning (known as implementation intentions) when setting between-session homework and the other augmentation will target patient drop-out by informing patients about group BA effectiveness and therapy-dose evidence. The stasis outcomes and drop-out rates from the enhanced treatment in the trial will be compared with the archived outcomes to see if the intervention has had an effect and the role of engaging in valued living as a mechanism of change for depression symptoms will be examined. It is hypothesised that a) 50% of patients who have received the existing BA group treatment for depression will have a stasis outcome, b) there will be a significant reduction in depression stasis outcomes and drop-out rate following the enhanced BA group treatment delivered in the trial and c) engagement in valued living will have a mediating effect on outcome for responding patients following the enhanced BA group treatment but the effect will not be present for patients with a stasis outcome.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who access the Sheffield Improving Access to Psychological Therapies (IAPT) service (United Kingdom) with depression as the primary presenting problem
  • Patients with co-morbid anxiety symptoms can be included as long as depression is the primary diagnosis
  • Are referred to and choose the Behavioural Activation Group (BAG) treatment option
  • Able to attend the BAG intervention
  • Aged 18 or over

排除标准

  • Primary diagnosis that is not depression
  • Patients who do not choose BAG as a treatment option
  • Aged under 18

研究组 & 干预措施

Enhanced Behavioural Activation Groups

Experimental

Behavioural activation group (BAG) psychotherapy delivered with two embedded treatment augmentations;

  1. Implementation intentions
  2. Dose-response psychoeducation

干预措施: Behavioural Activation Group (BAG) Psychotherapy (Behavioral)

结局指标

主要结局

Change in Patient Health Questionnaire (PHQ-9) scores

时间窗: 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

次要结局

  • Patient attendance at treatment sessions(Weeks 1-8 (every weekly treatment session - maximum of 8))
  • Change in Generalised Anxiety Disorder Assessment (GAD-7) score(Week 1 (pre-treatment), at every weekly treatment session attended (for 8 weeks) and at week 8 (end of treatment))
  • Change in Work and Social Adjustment Scale (WSAS) score(Week 1 (pre-treatment), at every weekly treatment session attended (for 8 weeks) and at week 8 (end of treatment))
  • Change in Valued Living Questionnaire (VLQ) score(Week 1 (pre-treatment), week 4 (at the 4th treatment session) and at week 8 (end of treatment))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melanie Simmonds-Buckley

PhD Research Student

University of Sheffield

研究点 (2)

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