Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000816651
Ethics application status
Approved
Date submitted
14/07/2014
Date registered
31/07/2014
Date last updated
28/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Single-session behavioural activation treatment for depression
Scientific title
Evaluation of a single session of Brief Behavioural Activation for Treatment for Depression (BATD): A randomised control trial in a community sample of individuals meeting diagnostic criteria for depression.
Secondary ID [1] 284925 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 292397 0
Condition category
Condition code
Mental Health 292716 292716 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to either the treatment or wait-list control condition after completing a diagnostic interview and relevant psychometric measures. The current intervention protocol will be based on Gawrysiak et al.’s (2009) modification of the revised Behavioral Activation Treatment for Depression (BATD-R) protocol, in which they condensed central components of the 10-session intervention into one 90-minute treatment session that includes psychoeducation on depression, treatment rationale, a life values assessment, setting weekly activity goals, and discussing ways the participant can monitor and modify weekly goals. The treatment interval is two weeks, during which time the participant will engage in scheduled activities and complete monitoring forms. Participants will complete the psychometric measures at the end of the two-week treatment interval and again at three-month follow-up.
Intervention code [1] 289748 0
Behaviour
Intervention code [2] 289930 0
Treatment: Other
Comparator / control treatment
Wait-list control. This group will be offered the treatment approximately one month after the initial interview/assessment has been conducted.
Control group
Active

Outcomes
Primary outcome [1] 293046 0
Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 293046 0
Two-week follow-up
Secondary outcome [1] 309218 0
Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 309218 0
Three-month follow up
Secondary outcome [2] 309219 0
Secondary Outcome 2: Valued Living Questionnaire score
Timepoint [2] 309219 0
Timepoint: following treatment interval of two weeks
Secondary outcome [3] 309220 0
Secondary Outcome 3: Reward Probability Index (RPI) score
Timepoint [3] 309220 0
Timepoint: Following treatment interval of two weeks.

Eligibility
Key inclusion criteria
Meets diagnostic criteria for depression
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current active suicidal intent;current psychosis; bipolar disorder diagnosis; currently undergoing psychological treatment for depression.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A spreadsheet column with equal parts study condition (intervention + control) will be sorted according to a randomly generated number sequence, using Microsoft excel software. Resulting in a randomly sorted list of study condition, to which participants will be allocated chronologically as they volunteer for the study.
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
A power analysis using G*power was calculated to determine the number of participants required for an 80% probability of capturing a ‘moderate’ interaction (i.e., f =.25) between group (intervention, control) and time (pre-test, post-test). According to G*Power, approximately 48 participants will be required (24 in each group). This was determined at an adjusted Bonferroni level of .0125.

Hypotheses will be tested with a series of Generalised Linear Mixed Models (GLMM). In order to optimise the likelihood of convergence, the GLMMs will be be tested separately for each of the outcome measures. To control for inflation of familywise errorrate, as a result of analysing each outcome independently of other, each GLMM will be evaluated at a Bonferroni adjusted alpha-level of .0125

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/08/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 289552 0
University
Name [1] 289552 0
School of Psychology and Speech Pathology, Curtin University
Country [1] 289552 0
Australia
Primary sponsor type
University
Name
School of Psychology and Speech Pathology, Curtin University
Address
Kent Street, Bentley, Western Australia 6102
Country
Australia
Secondary sponsor category [1] 288235 0
None
Name [1] 288235 0
Address [1] 288235 0
Country [1] 288235 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291293 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 291293 0
Kent Street, Bentley, W.A. 6102
Ethics committee country [1] 291293 0
Australia
Date submitted for ethics approval [1] 291293 0
30/05/2014
Approval date [1] 291293 0
25/07/2014
Ethics approval number [1] 291293 0
HR 149/2014

Summary
Brief summary
The proposed study aims to assess the efficacy of a single 90-minute session of a Brief Behavioural Activation for Depression (BATD) intervention in treating depressive symptoms in adults. BATD is a single-component intervention that increases access to environmental reward to improve mood. Treatment efficacy will be assessed by comparing outcome measures of a treatment group to a wait-list control group at pre-intervention and post-intervention. It is hypothesised that the treatment group will show significant reductions in self-reported depressive symptoms, as well as increases on measures of environmental reward and valued living, relative to the wait-list control group. It is hypothesised that these gains will be maintained at three-month follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49710 0
Dr Trevor Mazzucchelli
Address 49710 0
Curtin University, Kent Street, Bentley W.A. 6102
Country 49710 0
Australia
Phone 49710 0
+61 8 92667182
Fax 49710 0
Email 49710 0
Trevor.Mazzucchelli@curtin.edu.au
Contact person for public queries
Name 49711 0
Miss Natalie Burge
Address 49711 0
Curtin University, Kent Street, Bentley W.A. 6102
Country 49711 0
Australia
Phone 49711 0
+61 8 92663436
Fax 49711 0
Email 49711 0
natalie.burge@postgrad.curtin.edu.au
Contact person for scientific queries
Name 49712 0
Dr Trevor Mazzucchelli
Address 49712 0
Curtin University, Kent Street, Bentley W.A. 6102
Country 49712 0
Australia
Phone 49712 0
+61 8 92667182
Fax 49712 0
Email 49712 0
Trevor.Mazzucchelli@curtin.edu.au

No information has been provided regarding IPD availability


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.