BA Trial for Co-Occurring Depression and Substance Use

NCT03661580 | Completed DMC

• 1 other identifier: URMS: 157527
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire (PHQ-9)

  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.

  12 weeks

Secondary Outcomes (2)

• Percent Days Abstinent

  12 weeks

• Severity of Dependence

  12 weeks

Other Outcomes (1)

• Treatment Engagement

  6 weeks

Study Arms (2)

Behavioural Activation

EXPERIMENTAL

Participants in this arm receive 6 x weekly 1:1 sessions of BA delivered by a trained drugs and alcohol worker at the CDAT service. At the end of the 6-week intervention period participants will be referred back to their usual caseworker at the CDAT service, though they will be offered two BA booster sessions with their BA worker at 2-3 weeks and 4-5 weeks post-treatment. All participants in this arm will continue to have access to Treatment as Usual (i.e. prescribing) as required throughout the intervention period.

Behavioral: Behavioural Activation

Treatment as Usual

ACTIVE COMPARATOR

Participants in this arm will receive no change to the care they usually receive at the CDAT service.

Behavioral: Treatment as Usual

Interventions

Behavioural Activation BEHAVIORAL

The BA intervention will be the outpatient version of the Life Enhancement Treatment for Substance Use (LETS ACT; Daughters et al., 2008). This brief, manualised BA intervention has been specifically developed to meet the needs of patients with comorbid substance misuse and depression in drugs and alcohol treatment settings. LETS ACT targets the link between mood, substance use and behaviour, and focuses on identifying and increasing rewarding, substance-free activities that are based on the patient's own personal values.

Also known as: LETS ACT

Behavioural Activation

Treatment as Usual BEHAVIORAL

The control intervention in this study is Treatment as Usual at the CDAT service. Treatment as Usual consists of planned key-working sessions every 2-4 weeks with an allocated caseworker plus monthly prescribing review appointments with a medical practitioner for patients who require drug treatment medication. Key-working sessions are primarily focused on addressing substance misuse issues using a range of intervention techniques such as motivational interviewing and brief solution-focused therapy.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Sheffield: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Aspire Drug and Alcohol Service

Doncaster, South Yorkshire, DN1 2EZ, United Kingdom

Location

MeSH Terms

Conditions

Depression; Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jaime Delgadillo

  University of Sheffield

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: This study is a pragmatic, parallel group, randomised controlled trial assessing the efficacy of BA compared to treatment as usual (TAU) for patients with depression who are accessing Community Drugs and Alcohol Treatment.

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 7, 2018
• Study Start: September 12, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: December 4, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)