Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000662167
Ethics application status
Approved
Date submitted
23/04/2019
Date registered
3/05/2019
Date last updated
3/05/2019
Date data sharing statement initially provided
3/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of an online behavioural activation intervention combined with self-compassion training on wellbeing, behaviour, and depression symptoms in a non-clinical sample.
Scientific title
Behavioural activation and self-compassion: An investigation of the effects of an online behavioural activation intervention combined with self-compassion training on wellbeing, values-consistent behaviour, self-compassion, and depression symptoms in a non-clinical adult sample.
Secondary ID [1] 298026 0
Nil known
Universal Trial Number (UTN)
U1111-1232-0798
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subjective Wellbeing 312478 0
Eudaimonic Wellbeing 312479 0
Depression symptoms 312480 0
Condition category
Condition code
Mental Health 311025 311025 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will comprise a three-armed randomised pre-test post-test wait-list controlled study. The interventions that will be provided to participants in each arm are described below. All interventions will be self-directed, and distributed by email.

Arm 1: Behavioural Activation Intervention.
Participants in this arm of the study will be individually emailed an audio recording and a brief set of instructions (approximately two double-sided A4 pages) once per week for six weeks. The written instructions will be based upon Lejuez, Hopko, and Hopko's (2002) Brief Behavioural Activation for the Treatment of Depression (BATD) protocol, adapted to reflect a focus upon wellbeing rather than depression. Audio recordings will provide participants with an orientation to the written instructions and will approximately 1-2 minutes duration each. In week 1, instructions will focus on introducing the behavioural activation treatment approach, and inviting participants to monitor their daily activities. In week 2, participants will be invited to identify their values across three life areas, and activities that would be pleasant and/or meaningful for them to do that reflect those values. They will also be asked to continue monitoring their behaviour. During week 3, they will be asked to select and rank a list of activities from those identified the previous week, plan and implement activities, and to continue monitoring their behaviour. During week 4, they will be asked to continue activity selection, planning, and monitoring, and also to use a specific approach to enlisting social support to do their planned activities. During week 5, they will be asked to continue activity planning, selection, and monitoring, and enlisting social support. They will also be invited to review the values and activities they identified earlier in the program and consider adjusting them if needed. During week 6, they will be invited to review the skills they have learned, and to continue applying them post-treatment. Trouble-shooting ideas will be included in instruction sheets each week. It is estimated participants will spent approximately 10 to 15 minutes each day engaged in tasks outlined in the written instructions. The activities participants select to plan and do through these tasks, and the amount of time engaged in these activities, will be entirely up to them. Participants will also receive a second email mid-way through each week of the six-week intervention that will provide ideas and options to help them overcome barriers they may experience in implementing the tasks outlined in instructions that week.

Arm 2: Enhanced Behavioural Activation Intervention.
Participants in this intervention will be emailed the same written instruction sheets, on the same weekly schedule, as those in Arm 1. However, the audio recordings accompanying these written instructions will comprise a self-compassion training intervention informed by Compassion Focused Therapy (CFT; Gilbert 2000) instead of an orientation to the written materials (i.e., they will focus on inducing self-compassion). Each week for six weeks, the audio recording will include a guided self-compassion meditation activity designed to induce a self-compassionate attitude towards participation in behavioural activation tasks. In week 1, the audio recording will also provide an introduction to self-compassion and it's relevance to behavioural change, and will be approximately 14 minutes duration. In weeks 2 to 6, each audio recording will be approximately 6-7 minutes duration. Participants will also receive a second email mid-way through each week of the six-week intervention that will provide ideas and options to help them overcome barriers they may experience in implementing the tasks outlined in instructions that week.

Arm 3: Wait-list Control
Participants allocated to this condition will receive the same intervention materials as those in Arm 2, on the same weekly schedule. However, they will begin receiving these materials 20 weeks after those allocated to Arm 1 and Arm 2 (i.e., the week after three-month follow-up surveys are conducted).

Intervention fidelity will not be directly assessed and no strategies will be used to improve it. To provide a proxy measure of adherence a question will be included in mid-treatment and post-treatment surveys requesting participants to estimate what percentage of tasks allocated in weekly instruction sheets they completed during the preceding three week period.
Intervention code [1] 314256 0
Behaviour
Comparator / control treatment
A waitlist control (i.e. Arm 3 outlined in the Description of Interventions / Exposure section) will be used. Participants allocated to the waitlist control condition will receive the same intervention materials as those in Arm 2, on the same weekly schedule. However, they will begin receiving these materials 20 weeks after those allocated to Arm 1 and Arm 2 (i.e., the week after three-month follow-up surveys are conducted).
Control group
Active

Outcomes
Primary outcome [1] 319913 0
Satisfaction with life, measured using the Satisfaction With Life Scale
Timepoint [1] 319913 0
Timepoint 1: Baseline
Timepoint 2: 3 weeks from treatment commencement (mid-treatment)
Timepoint 3: 6 weeks from treatment commencement i.e., post-treatment (PRIMARY TIMEPOINT)
Timepoint 4: 10 weeks from treatment commencement
Timepoint 5: 20 weeks from treatment commencement
Primary outcome [2] 319914 0
Positive affect measured using the PA subscale of the Positive and Negative Affect Scales
Timepoint [2] 319914 0
Timepoint 1: Baseline
Timepoint 2: 3 weeks from treatment commencement (mid-treatment)
Timepoint 3: 6 weeks from treatment commencement i.e., post-treatment (PRIMARY TIMEPOINT)
Timepoint 4: 10 weeks from treatment commencement
Timepoint 5: 20 weeks from treatment commencement
Primary outcome [3] 319915 0
Negative affect measured using the NA subscale of the Positive and Negative Affect Scales
Timepoint [3] 319915 0
Timepoint 1: Baseline
Timepoint 2: 3 weeks from treatment commencement (mid-treatment)
Timepoint 3: 6 weeks from treatment commencement i.e., post-treatment (PRIMARY TIMEPOINT)
Timepoint 4: 10 weeks from treatment commencement
Timepoint 5: 20 weeks from treatment commencement
Secondary outcome [1] 369608 0
Value-consistent behaviour, measured using the Engaged Living Scale
Timepoint [1] 369608 0
Timepoint 1: Baseline
Timepoint 2: 3 weeks from treatment commencement (mid-treatment)
Timepoint 3: 6 weeks from treatment commencement i.e., post-treatment
Timepoint 4: 10 weeks from treatment commencement
Timepoint 5: 20 weeks from treatment commencement
Secondary outcome [2] 369609 0
Self-Compassion, measured using the Self-Compassion Scale
Timepoint [2] 369609 0
Timepoint 1: Baseline
Timepoint 2: 3 weeks from treatment commencement (mid-treatment)
Timepoint 3: 6 weeks from treatment commencement i.e., post-treatment
Timepoint 4: 10 weeks from treatment commencement
Timepoint 5: 20 weeks from treatment commencement
Secondary outcome [3] 369843 0
Eudaimonic wellbeing, measured using the Mental Health Continuum - Short Form
Timepoint [3] 369843 0
Timepoint 1: Baseline
Timepoint 2: 3 weeks from treatment commencement (mid-treatment)
Timepoint 3: 6 weeks from treatment commencement i.e., post-treatment
Timepoint 4: 10 weeks from treatment commencement
Timepoint 5: 20 weeks from treatment commencement
Secondary outcome [4] 369844 0
Depression symptoms measured using the Depression scale of the Depression Anxiety Stress Scales 21
Timepoint [4] 369844 0
Timepoint 1: Baseline
Timepoint 2: 3 weeks from treatment commencement (mid-treatment)
Timepoint 3: 6 weeks from treatment commencement i.e., post-treatment
Timepoint 4: 10 weeks from treatment commencement
Timepoint 5: 20 weeks from treatment commencement

Eligibility
Key inclusion criteria
Participants who are aged 18 years and over, are able to read English, and who provide an email address to which study materials and other communication may be sent, will be eligible to participate in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The following exclusion criteria apply:
- Being aged under 18 years
- Being unable to read English
- Not providing an email address to which study materials and other communication may be sent.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a randomisation schedule created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Participants in Arm 1 and Arm 2 will receive treatments in parallel, while those in Arm 3 receive no treatment. Twenty weeks later, those in Arm 3 (waitlist control group) will receive the same treatment as those in Arm 2.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be completed using multivariate linear mixed modelling using robust maximum likelihood (MLR) estimation. Required sample sizes were estimated using GLIMMPSE, an online power and size calculator for multilevel and mixed models (Kreidler et al., 2013). A power level of 0.8 and alpha level of 0.05 were used. The largest model will require a minimum sample size of 230 individuals to detect a “small” (equivalent to a Cohen’s d of 0.2) time by treatment interaction.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/05/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 21425 0
New Zealand
State/province [1] 21425 0

Funding & Sponsors
Funding source category [1] 302555 0
University
Name [1] 302555 0
Curtin University
Country [1] 302555 0
Australia
Funding source category [2] 302645 0
University
Name [2] 302645 0
University of Queensland
Country [2] 302645 0
Australia
Primary sponsor type
Individual
Name
Dr James Kirby
Address
University of Queensland
School of Psychology
Level 3, McElwain Building (24A)
The University of Queensland
St Lucia QLD 4072, Australia
Country
Australia
Secondary sponsor category [1] 302462 0
Individual
Name [1] 302462 0
Dr Trevor Mazzucchelli
Address [1] 302462 0
Curtin University
School of Psychology
GPO Box U1987
Perth Western Australia 6845
Country [1] 302462 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303198 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 303198 0
Office of Research Ethics
University of Queensland
St Lucia, Brisbane QLD 4072
Ethics committee country [1] 303198 0
Australia
Date submitted for ethics approval [1] 303198 0
07/03/2019
Approval date [1] 303198 0
02/04/2019
Ethics approval number [1] 303198 0
2019000498
Ethics committee name [2] 303199 0
Curtin University Human Research Ethics Committee
Ethics committee address [2] 303199 0
Curtin University Human Research Ethics Committee
Curtin University
GPO Box U1987
Perth Western Australia 6845
Ethics committee country [2] 303199 0
Australia
Date submitted for ethics approval [2] 303199 0
Approval date [2] 303199 0
15/04/2019
Ethics approval number [2] 303199 0
HRE2019-019

Summary
Brief summary
This study will aim to test whether a self-directed behavioural activation intervention is more effective in reducing depression symptoms and increasing subjective wellbeing and value-consistent behaviours in a non-clinical adult sample if enhanced with self-compassion training (EBA condition) than if delivered as a stand-alone intervention (BA condition). Several hypotheses will be tested, including:
(a) The mean rate of change in (i) depression symptoms, (ii) positive affect, (iii) negative affect, (iv) satisfaction with life, and (v) value-consistent behaviour will be greater amongst participants in the behavioural activation condition than the waitlist control condition.
(b) The mean rate of change in (i) depression symptoms, (ii) positive affect, (iii) negative affect, (iv) satisfaction with life, (v) value-consistent behaviour, and (vi) self-compassion will be greater for participants in the EBA condition than the BA condition.
(c) For participants in both the BA and EBA conditions, individuals with greater pre-test depression symptoms will have a larger rate of change in (i) positive affect, (ii) negative affect, and (iii) satisfaction with life than participants in the waitlist control condition.
(d) Participants in the EBA condition will be more likely than those in the BA condition to complete online survey measures (which will used as a proxy measure for treatment continuation).
Trial website
Trial related presentations / publications
Public notes
Note: Recruitment administration will be conducted in Western Australia and Queensland, but recruitment will occur online and therefore in any Australian State or Territory, and in any country outside Australia. New Zealand is listed only because this form requires a country outside Australia to be identified if recruitment occurs in countries outside Australia.

Contacts
Principal investigator
Name 92826 0
Dr James Kirby
Address 92826 0
School of Psychology
Level 3, McElwain Building (24A)
The University of Queensland
St Lucia QLD 4072, Australia
Country 92826 0
Australia
Phone 92826 0
+61 7 336 56802
Fax 92826 0
Email 92826 0
[email protected]
Contact person for public queries
Name 92827 0
Dr James Kirby
Address 92827 0
School of Psychology
Level 3, McElwain Building (24A)
The University of Queensland
St Lucia QLD 4072, Australia
Country 92827 0
Australia
Phone 92827 0
+61 7 336 56802
Fax 92827 0
Email 92827 0
[email protected]
Contact person for scientific queries
Name 92828 0
Dr James Kirby
Address 92828 0
School of Psychology
Level 3, McElwain Building (24A)
The University of Queensland
St Lucia QLD 4072, Australia
Country 92828 0
Australia
Phone 92828 0
+61 7 336 56802
Fax 92828 0
Email 92828 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?
All individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Beginning three months after main results publication; no end date determined.
Available to whom?
Researchers who provide a methodologically sound proposal, on a case-by-case basis at the discretion of the Primary Sponsor
Available for what types of analyses?
Any analyses, subject to provision of a methodologically and ethically sound proposal, and at the discretion of the Primary Sponsor.
How or where can data be obtained?
Access subject to approvals by 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.