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Trial registered on ANZCTR


Registration number
ACTRN12613000876796
Ethics application status
Approved
Date submitted
1/08/2013
Date registered
7/08/2013
Date last updated
3/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment for depression among individuals 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
Secondary ID [1] 282399 0
Nil
Universal Trial Number (UTN)
U1111-1142-2213
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression
288979 0
Substance Use Disorder 288980 0
Condition category
Condition code
Mental Health 289320 289320 0 0
Depression
Mental Health 289321 289321 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 287030 0
Behaviour
Comparator / control treatment
Treatment as usual: Opioid Replacement Therapy (ORT) or Residential Rehabilitation (RR).
Control group
Active

Outcomes
Primary outcome [1] 289431 0
Depression Severity
- Beck depression Index (BDI-II) score
- Composite International Diagnostic Interview (CIDI) Major Depression assessment
Timepoint [1] 289431 0
Baseline, 3 and 12 months.
Primary outcome [2] 289432 0
Drug Use and Substance Use Disorder
- CIDI assessment of Substance Use Disorder

Timepoint [2] 289432 0
Baseline, 3 and 12 months.
Secondary outcome [1] 302462 0
Treatment feasibility as assessed by treatment retention
Timepoint [1] 302462 0
Individual case treatment files will record all treatment session attendance on a week by week basis
Secondary outcome [2] 302463 0
Treatment feasibility as assessed by client satisfaction
-Score on the Client Satisfaction Questionnaire (CSQ)
Timepoint [2] 302463 0
BATD-R Intervention group only at 3 month follow up.
Secondary outcome [3] 304023 0
Factors that influence the efficacy of BATD-R including:
a. Client characteristics: demographic, drug use, psychological and physical health factors. These will be assessed using the following measures at baseline and 3 and 12 month follow up:
i. Demographic measures will include age, gender, level of school and tertiary education attained, employment status, and prison history.
ii. Drug use: Participants will be asked about their lifetime and current use of heroin, other opiates, methamphetamines, cocaine, hallucinogens, benzodiazepines, antidepressants, alcohol, cannabis, inhalants and tobacco. An estimate of the number of days each of these have been used in the past 3 months will be recorded. Drug Dependence will be measured using the CIDI version 3.0, and the Severity of Dependence Scale (SDS). Alcohol dependence will be screened for using the 4-item Cage questionnaire.
iii. Psychological factors: Depression symptoms will be measured using the Beck Depression Inventory-II (BDI-II) and CIDI 3.0 Depression module. Rumination about negative emotion will be assessed by the 15-item self-report Perseverative Thinking Questionnaire [PTQ]. The occurrence of rumination will also be explored using the Ruminative Response Scale [RRS]. Distress Tolerance will be measured using the Distress Tolerance Scale [DTS]. Anxiety symptoms will be measured using the Beck Anxiety Index (BAI). Participants will also be assessed for Social Phobia using CIDI 3.0. Traumatic events and trauma symptoms will be measured, using the PTSD trauma checklist from the CIDI, and the PCL-C Symptom Checklist. Participants will be screened for a potential ICD-10 diagnosis of borderline personality disorder using the International Personality Disorders Examination Questionnaire (IPDEQ). Sleep disturbance will be measured using the Pittsburgh Sleep Quality Index [PSQI]. Environmental reward will be measured using the Environmental Reward Observation Scale (EROS). Behavioural Activation will be assessed using the Behavioural Activation for Depression Scale- Short form [BADS-SF].
iv. Physical health will be assessed using physical health questions from the Australian National Survey of Mental Health and Wellbeing (NSMHWB).
b. Treatment characteristics: treatment compliance will be measured by recording session attendance, and monitoring session checklists completed by the therapists.
Timepoint [3] 304023 0
Baseline, 3 and 12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active suicidality
Active psychosis
Organic or traumatic brain injury

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random assignment by an individual independent of the research team, according to a computer-generated list of random numbers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic random allocation - minimisation method. The sample will be stratified by treatment modality and minimised by severity of depression and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Determination of sample size: Power analysis on the primary outcome variables (i.e., severity of drug dependence and depressive symptoms) was conducted using Power Analysis and Sample Size software. Based on our previous research, including a longitudinal study of treatment outcomes for heroin dependence, we assumed an exchangeable working correlation matrix and a within-subject correlation of 0.60 for dependence and 0.023 for depression. The proposed final sample size of 160 will enable us to detect clinically meaningful differences between the treatment and control groups. Specifically, it will allow us to detect a time-averaged difference of 3 in severity of drug dependence with a standard deviation of 5 (beta = 99% power; alpha=0.05); a 15% difference in the prevalence of dependence (beta = 96% power; alpha=0.05); a difference of 5 in BDI-II scores with a standard deviation of 15 (beta = 81% power; alpha=0.05); and a 15% difference in the prevalence of major depression (beta = 93% power; alpha=0.05). To allow for an expected attrition rate of 20%, the initial sample will be 200.

Statistical analysis: The proportion of screened clients entering the study will be determined. T-tests and chi-square analyses will be conducted to determine if those who did not enrol in the study were systematically different from those who did. T-tests and chi-square analyses will also be conducted to determine if there were any significant differences between the treatment and control groups.
For outcome analyses, both intention-to-treat and per-protocol analyses will be conducted. Categorical and continuous measures of outcome will be examined using mixed or marginal longitudinal models.

To evaluate treatment fidelity, ten percent of each therapist’s sessions will be rated for compliance with the treatment manual and inter-rater reliability by a blind assessor.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 952 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 7137 0
2065 - St Leonards
Recruitment postcode(s) [2] 7138 0
2039 - Rozelle
Recruitment postcode(s) [3] 7139 0
2036 - Malabar
Recruitment postcode(s) [4] 7140 0
2558 - Eagle Vale
Recruitment postcode(s) [5] 12752 0
2506 - Berkeley
Recruitment postcode(s) [6] 12753 0
2095 - Manly
Recruitment postcode(s) [7] 12754 0
2250 - Gosford
Recruitment postcode(s) [8] 12755 0
2008 - Chippendale
Recruitment postcode(s) [9] 12756 0
2017 - Waterloo
Recruitment postcode(s) [10] 12757 0
2130 - Summer Hill

Funding & Sponsors
Funding source category [1] 287173 0
Government body
Name [1] 287173 0
National Health and Medical Research Council (NHMRC)
Address [1] 287173 0
GPO Box 1421
Canberra ACT 2601
Country [1] 287173 0
Australia
Primary sponsor type
University
Name
National Drug and Alcohol Research Centre, University of New South Wales
Address
NDARC
University of New South Wales
Sydney NSW 2052, Australia
Country
Australia
Secondary sponsor category [1] 285938 0
None
Name [1] 285938 0
Address [1] 285938 0
Country [1] 285938 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289542 0
Human Research Ethics Committee at UNSW
Ethics committee address [1] 289542 0
Grants management Office,
Level 3, Rupert Myers Building South Wing
UNSW Kensington Campus NSW 2052
Ethics committee country [1] 289542 0
Australia
Date submitted for ethics approval [1] 289542 0
14/05/2013
Approval date [1] 289542 0
10/07/2013
Ethics approval number [1] 289542 0
HC13155
Ethics committee name [2] 294417 0
Northern Sydney Local Health District HREC
Ethics committee address [2] 294417 0
Research Office
Kolling Building, Level 13
Royal North Shore Hospital
St Leonards
NSW 2065
Ethics committee country [2] 294417 0
Australia
Date submitted for ethics approval [2] 294417 0
05/11/2012
Approval date [2] 294417 0
04/12/2013
Ethics approval number [2] 294417 0
HREC/12/HAWKE/404

Summary
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
Trial website
Trial related presentations / publications
Ross, J., Teesson, M., Lejuez, C., Mills, K., Kaye, S., Brady, K., Dore, G., Prior, K., Larkin, X., Cassar, J., Ewer, P., Memedovic, S., Kihas, I. & Masters, S.L. (2016) The efficacy of behavioural activation treatment for co-occurring depression and substance use disorder (the activate study): a randomized controlled trial. Study protocol. BMC Psychiatry, 16, 221.
Public notes

Contacts
Principal investigator
Name 39562 0
Prof Maree Teesson
Address 39562 0
NDARC
University of New South Wales
Sydney NSW 2052
Country 39562 0
Australia
Phone 39562 0
+61 02 9385 0331
Fax 39562 0
Email 39562 0
m.teesson@unsw.edu.au
Contact person for public queries
Name 39563 0
Dr Joanne Ross
Address 39563 0
NDARC
University of New South Wales
Sydney NSW 2052
Country 39563 0
Australia
Phone 39563 0
+61 02 9385 0235
Fax 39563 0
Email 39563 0
j.ross@unsw.edu.au
Contact person for scientific queries
Name 39564 0
Dr Joanne Ross
Address 39564 0
NDARC
University of New South Wales
Sydney NSW 2052
Country 39564 0
Australia
Phone 39564 0
+61 02 9385 0235
Fax 39564 0
Email 39564 0
j.ross@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary