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Treatment for depression among individuals with substance use disorder: The Activate Study

The efficacy of behavioural activation therapy for co-occurring depression and substance use disorder: The Activate Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000876796
Enrollment
132
Registered
2013-08-07
Start date
2013-08-12
Completion date
2015-02-26
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Behavioural activation (BA) is a treatment that aims to activate clients in ways that increase rewarding experiences in their lives, thereby reducing symptoms and behaviours characteristic of depression. BA has the advantage of being more time efficient and less complex than most other treatments for depression. This study is a clinical trial of an innovative behavioural activation treatment for depression (BATD-R) modified for use among people in treatment for substance use disorder (Activate). The aim of the study is to determine the efficacy of Activate (delivered individually) among opioid replacement therapy (ORT) and residential rehabilitation clients. The primary hypotheses are 1) Participants who receive Activate will demonstrate greater reductions in depression symptoms compared to those who receive treatment as usual (TAU), 2) Participants who receive Activate will demonstrate greater reductions in drug use and drug dependence compared to those who receive TAU. The project will also assess the feasibility of implementing BATD-R with ORT and residential rehabilitation clients. This will be measured by treatment retention, client compliance, client satisfaction, and therapist competence. Treatment efficacy will be determined by analysing changes in three outcome measures over the study period: 1. Depression symptoms 2) Substance use 3) Mental health comorbidity

Interventions

The intervention is Behavioural Activation Treatment for Depression (BATD-R), modified for use in out-patient and in-patient drug and alcohol treatment settings (Activate). BATD-R involves 10 individual 60 minute therapy sessions with a psychologist, delivered once a week for 10 weeks. Sessions include an examination of five key life areas and the client's values within each of these, as well as daily activity scheduling and problem solving. Activate has modified BATD-R to incorporate: psychoed

The intervention is Behavioural Activation Treatment for Depression (BATD-R), modified for use in out-patient and in-patient drug and alcohol treatment settings (Activate). BATD-R involves 10 individual 60 minute therapy sessions with a psychologist, delivered once a week for 10 weeks. Sessions include an examination of five key life areas and the client's values within each of these, as well as daily activity scheduling and problem solving. Activate has modified BATD-R to incorporate: psychoeducation about the role of substance use in depression; the use of motivational interviewing techniques for helping the client identify treatment goals related to their substance use; a brief relaxation technique and strategies for coping with craving; and self-soothing exercises. Treatment fidelity: Project staff will receive extensive training at the commencement of the project, including research procedures and role plays of assessment administration and treatment sessions. We will ensure treatment fidelity throughout the project by delivering the therapy in a consistent fashion, closely adhering to the treatment manual. The manual will be taken into each session by the therapist to ensure all proposed areas are covered. The therapist will also complete a session checklist, with any deviations from the therapy manual recorded in the clinical notes kept for each session. Weekly clinical supervision will be held with the CIs, where session checklists will be monitored. In addition, all treatment sessions will be recorded using MP3 recorders. Sessions will be uploaded onto computer for blind rating by an independent assessor. Ten percent of each therapist’s sessions will be randomly selected and rated for treatment fidelity (i.e., compliance with the treatment manual), and inter-rater reliability. Therapist will be controlled for in analyses of treatment outcome.

Sponsors

National Drug and Alcohol Research Centre, University of New South Wales
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

a) 18 years of age or older. b) Literate in English. c) Willing to give locator information. d) In ORT for 3 months or longer, or entered into RR within the last month. e) Endorse CIDI 3.0 screening criteria f) Score at least in the mild range on PHQ-9 g) Substance use in the month prior to interview h) Living in the greater Sydney metropolitan area I) Living in the community in the month prior to baseline

Exclusion criteria

Active suicidality Active psychosis Organic or traumatic brain injury

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 12, 2026