Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001115123
Ethics application status
Approved
Date submitted
26/07/2019
Date registered
12/08/2019
Date last updated
3/12/2020
Date data sharing statement initially provided
12/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy and mechanisms of change of group behavioural activation for depression compared with standard cognitive behaviour therapy
Scientific title
The efficacy and mechanisms of change of group behavioural activation for the treatment of clinical depression in adult patients compared with standard cognitive behaviour therapy
Secondary ID [1] 298839 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive disorders 313790 0
Condition category
Condition code
Mental Health 312205 312205 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Intervention consists of 11 face to face group behavioural activation therapy sessions offered over 14 weeks (weekly for 10 weeks then a review session at 14 weeks), provided at a publicly funded mental health clinic.
- Sessions consist of psychoeducation, counseling, self-monitoring, functional analysis of behaviour, skills training around self management, goal setting, activity scheduling, and worry deferment , and allocation of homework exercises (e.g. completion of activity diary, completion of a worry pad).
- Groups are facilitated by registered psychologists employed by the publicly funded health service.
- The intervention is based on an existing treatment manual "Overcoming Depression One Step at a Time: The New Behavioral Activation Approach to Getting Your Life Back. Addis, M. E., & Martell, C. R. (2004). New York: New Harbinger Press".
- Adherence to the intervention is monitored by group facilitators via a behavioural activation therapy self reflection adherence checklist and through supervision with a more senior psychologist. Participant attendance at groups is monitored using attendance logs. Participant homework completion each week is recorded on set homework proforma.
Intervention code [1] 315104 0
Treatment: Other
Comparator / control treatment
Comparator treatment consists of 11 face to face group cognitive behaviour therapy for depression sessions offered over 14 weeks (weekly for 10 weeks then a review session at 14 weeks), provided at a publicly funded mental health clinic.
- Group cognitive behaviour therapy (CBT) differs from group behavioural activation therapy (BA) in that CBT is primarily focused on changing mood through the analysis and modification of thinking patterns linked to depression, while BA is focused on changing mood through the functional analysis of behaviour and the replacement of avoidance behaviours with behaviours associated with greater reinforcement.
- Groups are facilitated by registered psychologists employed by the publicly funded health service.
- The intervention is based on an existing treatment manual and not personalised. The CBT manual is not based on any specific guidelines but consists of standard CBT components common to most empirically supported variants of CBT programs for depression.
- Adherence of the intervention is monitored by group facilitators via a standardised measure and through supervision with a more senior psychologist.
- The particular CBT group program in question has previously been evaluated in a clinical trial (Craige & Nathan, 2009, Behavior Therapy, 20, 302-3014).
Control group
Active

Outcomes
Primary outcome [1] 320834 0
Change in patient self-reported scores on the Beck Depression Inventory II (BDI-II), a widely used standardised self-report measure of depression symptoms.
Timepoint [1] 320834 0
Outcome is collected at treatment commencement and at weeks 5, 10 and 14 of the intervention. The primary time point for this measure is at 10 weeks of the intervention.
Secondary outcome [1] 372994 0
Change in patient self-reported scores on the Depression Anxiety and Stress Scale (DASS-21) , a widely used standardised self-report measure of depression and anxiety symptoms.
Timepoint [1] 372994 0
Outcome is collected at treatment commencement and at weeks 5, 10 and 14 of the intervention.
Secondary outcome [2] 372995 0
Change in patient self-reported scores on the Cognitive-Behavioural Therapy Skills Questionnaire (CBTSQ) a widely used standardised self-report measure of cognitive and behavioural coping skills use.
Timepoint [2] 372995 0
Outcome is collected at treatment commencement and at weeks 5, 10 and 14 of treatment.
Secondary outcome [3] 372996 0
Change in patient self-reported scores on the cognitive and behavioural avoidance scale (CBAS), a widely used standardised self-report measure of avoidant behaviours.
Timepoint [3] 372996 0
Outcome is collected as treatment commencement and at weeks 5, 10, and 14 of the intervention.

Eligibility
Key inclusion criteria
Adult patients of the public mental health service with a current diagnosis of a depressive disorder.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include acute psychosis or imminent suicide risk or a current diagnosis of intellectual disability or major neurocognitive disorder.

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)
Participants randomised by a senior psychologist not involved in the study using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by an online random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The statistical methods used to analyse the results of study will include zero-order Pearson’s correlation, Chi square, t test, Analysis of Variance (ANOVA) repeated measures ANOVA and repeated measures Multivariate Analysis of Variance (MANOVA). With an expected power of 0.75 (medium-to-large) and power set at 0.95 and error probability at 0.01, for a repeated measures MANOVA that includes both within and between groups over 4 measurement points, a total sample size of 47 will be required. Factoring in 7% attrition observed in similar studies at the same site, the expect sample size of 120 subjects will more than adequately power this study. Prediction and mediator analyses are to be conducted using multilevel modelling via MLwiN to account for the nested structure of the data (treatment groups nested within individuals).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/07/2014
Date of last participant enrolment
Anticipated
Actual
16/07/2019
Date of last data collection
Anticipated
23/10/2019
Actual
23/10/2019
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14314 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 27314 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 303388 0
Hospital
Name [1] 303388 0
Princess Alexandra Hospital
Country [1] 303388 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
199 Ipswich Road, Woolloongabba, QLD, 4102,
Country
Australia
Secondary sponsor category [1] 303428 0
None
Name [1] 303428 0
Address [1] 303428 0
Country [1] 303428 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303917 0
Metro South Human Research Ethics Commitee
Ethics committee address [1] 303917 0
Ethics committee country [1] 303917 0
Australia
Date submitted for ethics approval [1] 303917 0
11/06/2013
Approval date [1] 303917 0
15/11/2013
Ethics approval number [1] 303917 0
HREC/13/QPAH/424

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95242 0
Dr Nathan Pasieczny
Address 95242 0
School of Psychology
The University of Queensland
Level 3, McElwain Building
St Lucia QLD 4072, Australia.
Country 95242 0
Australia
Phone 95242 0
+61 7 33656230
Fax 95242 0
Email 95242 0
[email protected]
Contact person for public queries
Name 95243 0
Nathan Pasieczny
Address 95243 0
School of Psychology
The University of Queensland
Level 3, McElwain Building
St Lucia QLD 4072, Australia.
Country 95243 0
Australia
Phone 95243 0
+61 7 33656230
Fax 95243 0
Email 95243 0
[email protected]
Contact person for scientific queries
Name 95244 0
Nathan Pasieczny
Address 95244 0
School of Psychology
The University of Queensland
Level 3, McElwain Building
St Lucia QLD 4072, Australia.
Country 95244 0
Australia
Phone 95244 0
+61 7 33656230
Fax 95244 0
Email 95244 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results.
When will data be available (start and end dates)?
Immediately after publication, no end date.
Available to whom?
Case-by-case basis at the discretion of the Primary Sponsor.
Available for what types of analyses?
Case-by-case basis at the discretion of the Primary Sponsor.
How or where can data be obtained?
Access subject to approvals by principle investigator (email: [email protected]) and Primary Sponsor.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.