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临床试验/NCT03661580
NCT03661580已完成不适用

Integrating Behavioural Activation for Depression Into Community Drugs and Alcohol Treatment: A Randomised Controlled Trial

University of Sheffield2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年9月12日最近更新:
适应症

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
Patient Health Questionnaire (PHQ-9)

研究概览

简要总结

A large proportion of people seeking treatment for drug and alcohol issues also have clinically significant depression symptoms. This combination of problems tends to have a negative impact on treatment and leads to poor health and disability, yet relatively few studies have focused on the development of interventions for treating this comorbidity. There is emerging evidence to suggest that Behavioural Activation (BA) may be a viable and cost-effective treatment for comorbid depression and substance use problems, however more research is needed in order to establish its effectiveness in routine practice. The aim of this study is therefore to investigate the efficacy of a brief (6-session), manualised BA intervention among service users with depression who are accessing Community Drugs and Alcohol treatment. We are planning to recruit up to 128 service users who are actively using substances to be randomly assigned to either the 6-week BA intervention or Treatment as Usual in Community Drugs and Alcohol services. These participants will be recruited from either a Community Drugs and Alcohol service or a Community Mental Health service. Our research will assess whether the BA intervention is more effective than usual care in (1) reducing depression symptoms, (2) reducing substance use, and (3) improving treatment engagement (i.e. session attendance). We expect that our results will establish the efficacy of integrating BA for depression into routine Community Drugs and Alcohol Treatment.

详细描述

RATIONALE Over 50% of treatment-seeking substance users present with clinically significant depression symptoms (Johnson, Neal, Brems, & Fisher, 2006). This combination of problems tends to complicate treatment (e.g. Carroll et al., 1993) resulting in greater functional impairment (Johnson et al., 1995) and poor health outcomes (Hasin et al., 2002). Treatment protocols for co-occurring mental health and substance misuse have traditionally focused on treating these issues separately, however there is now increasing consensus that integrated approaches to treatment are more effective (Davidson et al., 2010) and subsequently a growing interest into how targeted mental health support can be incorporated into standard drug and alcohol treatment.

CBT is deemed to be one of the most effective psychological treatments for depression, though may be too complex and time-consuming for effective delivery in routine CDAT. Emerging evidence suggests that a more suitable intervention in this context may be Behavioural Activation (BA); a brief, manualised intervention which targets depression symptoms by increasing engagement in rewarding, values-based activities (Lejuez, Hopko, Acierno, Daughters, & Pagoto, 2011). Indeed, previous studies have found that BA is associated with reductions in both depression symptoms and substance use (Daughters et al., 2018; Daughters et al., 2008; Delgadillo et al., 2015), as well as improved treatment retention among substance misuse service users with comorbid depression (Magidson et al., 2011). The only known trial of BA in UK Community Drugs and Alcohol Treatment (CDAT) was conducted by Delgadillo and colleagues (2015), however this study was under-powered and employed qualified mental health practitioners to deliver the intervention which may be too costly or unfeasible to implement in routine practice. More research is needed to establish the efficacy of BA in CDAT services, and given that BA may be delivered effectively with minimal training by staff who are not formally trained as psychological therapists (Ekers et al., 2008), it seems that the most suitable and cost-effective way of integrating BA into routine drug and alcohol treatment would be to upskill the existing workforce.

Accordingly, given the high prevalence and impact of comorbid depression among addiction service users, along with evidence to suggest that BA is an effective and acceptable intervention for treating this population, the present study will expand on previous research by conducting a trial to evaluate the efficacy of BA delivered by trained drugs and alcohol workers in a sample of patients accessing treatment for substance use. The central research question is: How effective is Behavioural Activation for treating depression in substance users compared to treatment as usual in Community Drugs and Alcohol services?

AIMS

The proposed study aims to:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Are currently engaging with a Community Drugs and Alcohol Treatment (CDAT) service. Engagement is defined by (a) being currently registered with the service and (b) having had planned contact with the service within the last month.
  • Meet criteria for a current depressive disorder as defined by a score of 12 or more on the PHQ-9 questionnaire. Comorbid anxiety disorders are not exclusion criteria, as long as depression is the primary disorder.
  • Meet criteria for mild-to-moderate severity of drug dependence, as defined by a score between 0 - 10 on the Severity of Dependence Questionnaire.
  • Have used alcohol or illicit drugs within the last month.

排除标准

  • Are not currently engaging with a Community Drugs and Alcohol Treatment (CDAT) service
  • Are assessed as having a high risk of suicide warranting involvement with crisis services
  • Have an organic or acquired brain injury
  • Do not currently meet criteria for depressive disorder as defined by the PHQ-9 questionnaire score.
  • Meet criteria for depression and a comorbid anxiety disorder, as identified by the GAD-7 questionnaire. Where the anxiety disorder is more severe, has been of longer duration than depressive symptoms and is the patient's main concern.
  • Patients with severe mental health problems who are already involved in psychiatric or secondary care mental health services.
  • Are free of substances of dependence
  • Those who have a severe drug or alcohol dependence, as defined by a score above 10 on the Severity of Dependence Questionnaire.

结局指标

主要结局

Patient Health Questionnaire (PHQ-9)

时间窗: 12 weeks

Change in depression at post-treatment follow-up via the PHQ-9 (Kroenke et al., 2001). The PHQ-9 is a brief (9-item) self-report 4-point Likert-type scale measure is based on the Diagnostic and Statistical Manual (DSM-IV) diagnostic criteria for major depressive disorder. Each item is rated on a 0 to 3 scale relating to the frequency of depressive symptoms over the last two weeks (0 = 'not at all', 3 = 'nearly every day'). Scores range from 0 to 27 with higher scores indicating a greater severity of depression.

次要结局

  • Percent Days Abstinent(12 weeks)
  • Severity of Dependence(12 weeks)

研究者

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

Sophie Pott

PhD Student

University of Sheffield

研究点 (2)

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