Data category | Information |
---|---|
Primary registry and trial identifying number | Australian and New Zealand Clinical Trials registry, ACTRN12613000876796 |
Date of registration in primary registry | 7 August, 2013 |
Secondary identifying numbers | Universal Trial Number U1111-1142-2213 |
Source(s) of monetary or material support | National Health and Medical Research Council |
Primary sponsor | National Drug & Alcohol Research Centre, University of New South Wales, Sydney, NSW 2052 |
Contact for public queries | Joanne Ross (j.ross@unsw.edu.au) |
Contact for scientific queries | Joanne Ross National Drug & Alcohol Research Centre, UNSW, Sydney, Australia |
Public title | Treatment for depression among people with substance use disorder: The Activate Study |
Scientific title | The efficacy of behavioural activation therapy for co-occurring depression and substance use disorder: The Activate Study |
Countries of recruitment | Australia |
Health condition(s) or problem(s) studied | Depression and Substance Use Disorder |
Intervention(s) | The intervention is Behavioral Activation Treatment for Depression (BATD-R), modified for use in outpatient and in-patient drug and alcohol treatment settings (Activate). Comparator: Treatment as usual i.e. Residential Rehabilitation (RR) or Opioid Substitution Treatment (OST). |
Key inclusion and exclusion criteria | Inclusion criteria: a) 18Â years of age or older b) Literate in English c) Willing to give locator information d) Entered RR within the last month or in OST for at least 3Â months e) Endorse CIDI 3.0 depression screening criteria f) Score at least in the mild range on PHQ-9 g) Substance use in the month prior to interview Exclusion criteria: a) Active suicidality b) Active psychosis c) Organic or traumatic brain injury d) Not living in the greater Sydney metropolitan area e) Not living in the community in the month prior to baseline |
Study type | Interventional. Allocation: randomised; intervention model: parallel assignment; Masking: the research officers assessing outcomes are blind to the allocation Primary purpose: Treatment |
Date of first enrolment | 12/08/2013 |
Target sample size | 200 |
Recruitment status | Recruitment completed. Analysis ongoing. |
Primary outcome(s) | 1) Depression Severity  - Beck Depression Inventory (BDI-II) score  - Composite International Diagnostic Interview 3.0 (CIDI) assessment of Major Depression. 2) Substance Use Disorder  - CIDI assessment of substance use disorder  - Severity of dependence scale (SDS) |
Key secondary outcomes | 1) Treatment feasibility as assessed by treatment retention and client satisfaction (assessed using the Client Satisfaction Questionnaire on completion of the Activate intervention) 2) Factors that influence the efficacy of the modified BATD-R (Activate) including client and treatment characteristics (assessed at baseline, 3 and 12Â months). |