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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]

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

Eudaimonic Wellbeing

Depression symptoms

Condition category

Condition code

Mental Health

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]

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]

Satisfaction with life, measured using the Satisfaction With Life Scale

Timepoint [1]

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]

Positive affect measured using the PA subscale of the Positive and Negative Affect Scales

Timepoint [2]

Primary outcome [3]

Negative affect measured using the NA subscale of the Positive and Negative Affect Scales

Timepoint [3]

Secondary outcome [1]

Value-consistent behaviour, measured using the Engaged Living Scale

Timepoint [1]

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]

Self-Compassion, measured using the Self-Compassion Scale

Timepoint [2]

Secondary outcome [3]

Eudaimonic wellbeing, measured using the Mental Health Continuum - Short Form

Timepoint [3]

Secondary outcome [4]

Depression symptoms measured using the Depression scale of the Depression Anxiety Stress Scales 21

Timepoint [4]

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Curtin University

Address [1]

Curtin University, GPO Box U1987, Perth Western Australia 6845

Country [1]

Australia

Funding source category [2]

University

Name [2]

University of Queensland

Address [2]

University of Queensland, St Lucia, Brisbane Queensland 4072

Country [2]

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]

Individual

Name [1]

Dr Trevor Mazzucchelli

Address [1]

Curtin University
School of Psychology
GPO Box U1987
Perth Western Australia 6845

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Queensland Human Research Ethics Committee

Ethics committee address [1]

Office of Research Ethics
University of Queensland
St Lucia, Brisbane  QLD 4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/03/2019

Approval date [1]

02/04/2019

Ethics approval number [1]

2019000498

Ethics committee name [2]

Curtin University Human Research Ethics Committee

Ethics committee address [2]

Curtin University Human Research Ethics Committee
Curtin University
GPO Box U1987 
Perth Western Australia 6845

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

15/04/2019

Ethics approval number [2]

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

Dr James Kirby

Address

School of Psychology
Level 3, McElwain Building (24A)
The University of Queensland
St Lucia QLD 4072, Australia

Country

Australia

Phone

+61 7 336 56802

Fax

[email protected]

Contact person for public queries

Name

James Kirby

Address

School of Psychology
Level 3, McElwain Building (24A)
The University of Queensland
St Lucia QLD 4072, Australia

Country

Australia

Phone

+61 7 336 56802

Fax

[email protected]

Contact person for scientific queries

Name

James Kirby

Address

School of Psychology
Level 3, McElwain Building (24A)
The University of Queensland
St Lucia QLD 4072, Australia

Country

Australia

Phone

+61 7 336 56802

Fax

[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.

Trial Review

Documents added manually

Documents added automatically