Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000184572
Ethics application status
Approved
Date submitted
13/02/2015
Date registered
25/02/2015
Date last updated
18/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
An Evaluation of a Group Intervention for Caregivers of Individuals with Bipolar Disorder
Scientific title
For caregivers of people with bipolar disorder, does group psychoeducation, compared to waitlist control, reduce perceived burden and symptoms of emotional disorder?
Secondary ID [1] 286171 0
Nil
Universal Trial Number (UTN)
Nil.
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perceived Burden of caring for someone with bipolar disorder 294187 0
Depression 294188 0
Anxiety 294189 0
Stress 294190 0
Self-efficacy caring for someone with bipolar disorder 294191 0
Condition category
Condition code
Mental Health 294512 294512 0 0
Depression
Mental Health 294513 294513 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention requires eligible participants attend two, 150-minute group psychoeducation sessions spaced one week apart. Participants will be provided with educational information about bipolar disorder, its treatment and coping strategies for themselves as a caregiver of someone with bipolar disorder.

Sessions will be audiorecorded and adherence to protocol by the facilitators will be assessed by independent raters.
Intervention code [1] 291175 0
Behaviour
Comparator / control treatment
Waitlist control. Waitlist participants will receive assessments at the same timepoints as the immediate intervention group.

Waitlist participants will receive the intervention after the 1-month follow-up assessment.
Control group
Active

Outcomes
Primary outcome [1] 294291 0
Perceived care-giving burden, as measured by the Burden Assessment Scale.
Timepoint [1] 294291 0
Baseline (immediately prior to first group session) to immediately after the second group session 1-week later and to 1-month follow-up.
Primary outcome [2] 294292 0
Caregiver emotional distress, as measured by the Depression, Anxiety, and Stress Scale (DASS-21) total score.
Timepoint [2] 294292 0
Baseline (immediately prior to first group session) to immediately after the second group session 1-week later and to 1-month follow-up.
Primary outcome [3] 294293 0
Caregivers' knowledge of bipolar disorder, support and self-care strategies, as measured by the Knowledge of Bipolar Disorder Scale.
Timepoint [3] 294293 0
Baseline (immediately prior to first group session) to immediately after the second group session 1-week later and to 1-month follow-up.
Secondary outcome [1] 312970 0
Caregivers' coping self-efficacy, as measured by the Managing Bipolar Disorder Scale.
Timepoint [1] 312970 0
Baseline (immediately prior to first group session) to immediately after the second group session 1-week later and to 1-month follow-up.

Eligibility
Key inclusion criteria
Inclusion criteria for participation in this study will be: 1) aged over 18 years; 2) the ability to speak and read English fluently, 3) a caregiver of someone with diagnosed bipolar disorder, defined as a friend, family member or partner.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Aged under 18 years
Inability to speak and read English fluently
Not being a caregiver (friend, family, partner) of someone with bipolar disorder
Caregiver is a currently receiving therapy related to supporting the individual with bipolar disorder.

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)
Potential participants who express an interest in the study will be contacted by the associate investigator (Miller) who will complete the initial screening interview over the phone. Participants who meet inclusion criteria will then be sent the information sheet, consent form and baseline measures. The coordinating principal investigator (McEvoy) who is off-site will generate a randomisation schedule and allocate participants to waitlist control or immediate intervention. Participants will be informed via telephone which condition they are in.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation schedule will be generated using www.random.org
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 software was conducted assuming a low to medium effect size (f = .20), an alpha of .05, power of .80, an autocorrelation of .5, and three measurement occasions. This analysis suggested that a minimum of 42 (21 per group) participants be recruited.

Five hypotheses are proposed

H1: Participants will report significantly greater pre-post reductions in burden (as measured by the BAS) compared to controls.

H2: Participants will report significantly greater pre-post reductions in symptoms of depression, anxiety, and stress (as measured by the DASS) compared to controls.

H3: Participants will report significantly greater pre-post improvements in knowledge of bipolar disorder, support and self-care strategies (as measured by the Knowledge of Bipolar Disorder Scale), compared to controls

H4: Participants will report significantly greater pre-post improvements in bipolar disorder coping self-efficacy (as measured by a scale adapted from the Managing Bipolar Disorder Scale) compared to controls

H5: The effects hypothesised in H1 – H4 will be maintained at one-month follow-up.


The five hypotheses will be tested with a series of Generalised Linear Mixed Models (GLMMs) – one for each outcome measure. For the GLMM’s, there is one nominal random effect (participant), one fixed nominal effect of group (intervention, waitlist), and one ordinal fixed effect (time: baseline for those in the waitlist condition, pre, post, follow-up for all participants). All hypotheses predict a significant Group by Time interaction effect.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/03/2015
Actual
10/04/2015
Date of last participant enrolment
Anticipated
30/09/2015
Actual
17/08/2015
Date of last data collection
Anticipated
Actual
10/09/2015
Sample size
Target
42
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 290741 0
Self funded/Unfunded
Name [1] 290741 0
Country [1] 290741 0
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, Perth, Western Australia, 6102
Country
Australia
Secondary sponsor category [1] 289427 0
Government body
Name [1] 289427 0
Centre for Clinical Interventions, WA Health Department
Address [1] 289427 0
223 James Street, Northbridge, WA, 6003
Country [1] 289427 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292373 0
North Metropolitan Health Service - Mental Health Human Research Ethics Committee
Ethics committee address [1] 292373 0
Ethics committee country [1] 292373 0
Australia
Date submitted for ethics approval [1] 292373 0
19/12/2014
Approval date [1] 292373 0
06/03/2015
Ethics approval number [1] 292373 0
01_2015
Ethics committee name [2] 292746 0
Curtin University Human Research Ethics Office
Ethics committee address [2] 292746 0
Ethics committee country [2] 292746 0
Australia
Date submitted for ethics approval [2] 292746 0
Approval date [2] 292746 0
11/03/2015
Ethics approval number [2] 292746 0
HR43/2015

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 426 426 0 0
/AnzctrAttachments/367965-HR43_2015.pdf
Attachments [2] 427 427 0 0
/AnzctrAttachments/367965-01_2015 HREC approval letter 06032015.pdf

Contacts
Principal investigator
Name 54918 0
A/Prof Peter McEvoy
Address 54918 0
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, WA, 6102
Country 54918 0
Australia
Phone 54918 0
+618 9266 5110
Fax 54918 0
Email 54918 0
[email protected]
Contact person for public queries
Name 54919 0
Peter McEvoy
Address 54919 0
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, WA, 6102
Country 54919 0
Australia
Phone 54919 0
+618 9266 5110
Fax 54919 0
Email 54919 0
[email protected]
Contact person for scientific queries
Name 54920 0
Peter McEvoy
Address 54920 0
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, WA, 6102
Country 54920 0
Australia
Phone 54920 0
+618 9266 5110
Fax 54920 0
Email 54920 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseBrief group psychoeducation for caregivers of individuals with bipolar disorder: A randomized controlled trial.2016https://dx.doi.org/10.1016/j.jad.2016.04.013
N.B. These documents automatically identified may not have been verified by the study sponsor.