Trial Review

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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
ACTRN12623000043639
Ethics application status
Approved
Date submitted
10/01/2023
Date registered
16/01/2023
Date last updated
18/09/2023
Date data sharing statement initially provided
16/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Telehealth-delivered well-being plan group program for adults living with bipolar disorder: Phase 1
Scientific title
Telehealth-delivered recovery-orientated well-being plan group program for adults living with bipolar disorder: a pilot randomized feasibility and acceptability study: Phase 1
Secondary ID [1] 308717 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder 328652 0
Condition category
Condition code
Mental Health 325664 325664 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the treatment condition attend an 8-week well-being planning group telehealth-delivered program (via zoom). Each session lasts approximate 1.5 hours and is conducted once a week. Maximum group size is 10 participants.
The program contains elements of cognitive behaviour therapy, psychoeducation about bipolar disorder, stigma and coping and is delivered by a registered psychologist. Each week the content covered relates to a different section of the well-being plan, with participants required to complete a section of their plan each week as homework. The completed well-being plan is then submitted at the end of the program. Session attendance is marked each week on a checklist.
Intervention code [1] 325182 0
Treatment: Other
Comparator / control treatment
Treatment as usual (standard care) control condition. Standard care is defined as currently under the care of a GP or psychiatrist.
Control group
Active

Outcomes
Primary outcome [1] 333510 0
Drop out/retention rate This is assessed at the completion of the program through an audit of attendance.
Timepoint [1] 333510 0
Post-completion of the intervention (8 weeks post-baseline)
Primary outcome [2] 333511 0
Mean number of sessions attended Calculated at the conclusion of the study based through an audit of attendance.
Timepoint [2] 333511 0
Post-completion of the intervention (8 weeks post-baseline)
Secondary outcome [1] 417321 0
Qualitative feedback overall regarding content of the program. This will be assessed using a semi-structured interview. This includes questions relating to the content of the program and delivery.
Timepoint [1] 417321 0
Post-completion of the intervention (8 weeks post-baseline)
Secondary outcome [2] 417513 0
Completion of wellbeing plan. The extent of the well-being plan that is completed is assessed by an audit of the study records.
Timepoint [2] 417513 0
Post-completion of the intervention (8 weeks post-baseline).

Eligibility
Key inclusion criteria
The inclusion criteria were being over 18 years of age, having a confirmed diagnosis of bipolar disorder, being under the care of a GP or psychiatrist.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were being located outside of Australia

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
Data on feasibility and acceptability (number of sessions attended, completion of well-being plan, dropout rates) are collected throughout this trial phase. Qualitative data are analysed using a content analysis framework employing a directed approach

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2021
Date of last participant enrolment
Anticipated
1/04/2023
Actual
1/04/2023
Date of last data collection
Anticipated
30/06/2023
Actual
30/06/2023
Sample size
Target
40
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312940 0
University
Name [1] 312940 0
Western Sydney University
Country [1] 312940 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797. Penrith NSW 2751.
Country
Australia
Secondary sponsor category [1] 314662 0
University
Name [1] 314662 0
Western Sydney University
Address [1] 314662 0
Locked Bag 1797. Penrith NSW 2751.
Country [1] 314662 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312213 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 312213 0
Ethics committee country [1] 312213 0
Australia
Date submitted for ethics approval [1] 312213 0
Approval date [1] 312213 0
09/03/2021
Ethics approval number [1] 312213 0
H14254

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

Contacts
Principal investigator
Name 123870 0
Dr Tania Perich
Address 123870 0
Western Sydney University Locked Bag 1797. Penrith NSW 2751.
Country 123870 0
Australia
Phone 123870 0
+61297726416
Fax 123870 0
Email 123870 0
[email protected]
Contact person for public queries
Name 123871 0
Tania Perich
Address 123871 0
Western Sydney University Locked Bag 1797. Penrith NSW 2751.
Country 123871 0
Australia
Phone 123871 0
+61297726416
Fax 123871 0
Email 123871 0
[email protected]
Contact person for scientific queries
Name 123872 0
Tania Perich
Address 123872 0
Western Sydney University Locked Bag 1797. Penrith NSW 2751.
Country 123872 0
Australia
Phone 123872 0
+61297726416
Fax 123872 0
Email 123872 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case basis

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• Meta-analyses

When can requests for individual participant data be made (start and end dates)?
From:
15 years from completion of study

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Contacting the Principal Investigator [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.