BA Trial for Co-Occurring Depression and Substance Use

NCT03661580 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-12-04

No results posted yet for this study

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

Interventions

BEHAVIORAL

Behavioural Activation

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.

BEHAVIORAL

Treatment as Usual

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.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER
  • University of Sheffield

    lead OTHER

Principal Investigators

  • Jaime Delgadillo · University of Sheffield

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-12
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03661580 on ClinicalTrials.gov