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Table 1 Trial registration data set as recommended by the World Health Organization (WHO)

From: The efficacy of behavioural activation treatment for co-occurring depression and substance use disorder (the activate study): a randomized controlled trial

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) 18 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 3 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 12 months).
  1. Date and version identifier: Issue date: 17 Feb 2016
  2. Protocol amendment number: 01 Authors: KP, JR
  3. Revision chronology:
  4. 00, 7 August, 2013 Original
  5. 01, 17 February, 2016 Amendment 01.:
  6. Two exclusion criteria, i.e. d) not living in the greater Sydney metropolitan area and e) not living in the community in the month prior to baseline, were added, as omitted from the original list
  7. Actual date that the first participant entered the study was added (12.08.13)
  8. Date of last participant enrolment was changed from 3.12.14 to 26.02.15. The baseline recruitment phase was extended due to delays with ethics and to help boost recruitment
  9. List of recruitment sites was updated
  10. File updated to indicate that Ethics Approval was obtained from Northern Sydney Local Health District HREC on 4 December 2013