Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001179123
Ethics application status
Approved
Date submitted
3/07/2019
Date registered
20/08/2019
Date last updated
16/06/2024
Date data sharing statement initially provided
20/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of BipolarWISE, an innovative online psychosocial intervention
Scientific title
Development of BipolarWISE – a program about living well with bipolar disorder
Secondary ID [1] 298508 0
None
Universal Trial Number (UTN)
U1111-1235-6790
Trial acronym
BipolarWISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar disorder
 313308 0
Carer mental health 313359 0
Condition category
Condition code
Mental Health 311744 311744 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The BipolarWISE program involves:
(1) Eleven group sessions with a maximum of eight other participants with bipolar disorder and two facilitators who are allied health professionals (research facilitators). Each session will be around 120 minutes with a break in the middle. To maximise convenience for participants, these sessions will be held online via videoconferencing software.
(2) An initial individual orientation session with a facilitator and 10 individual coaching sessions (11 individual sessions in total) of around 30 minutes with a facilitator, to help tailor the program to participants needs. These sessions will be conducted via phone or other videoconferencing software.
(3) In addition, the allied health facilitators will assist participants to develop a secure login and personalised profile on the BipolarWISE App that is integrated into the program, and to use whatever features participants may like to try (e.g., monitoring, goal setting, plans, information and resources). Before participants access the BipolarWISE App for the first time, they will be asked to read and agree to the Terms of Use, Privacy Statement and Disclaimer. They are welcome to discuss any questions they may have about the Terms of Use, Privacy Statement and Disclaimer with the research facilitators. If they have difficulty applying the information and tools on the app to their situation or technical difficulty, they can email, text, or call the facilitators. Between sessions the research facilitators will send participants brief emails with feedback related to their goals, and a reminder about the next session.
(4) A separate carer component, BipolarASSIST, which is separate from the rest of the BipolarWISE intervention in that carers have their own independent online resource. It will be a mobile app which is an upgraded and privately accessible version of www.bipolarcaregivers.org, that includes psychoeducation and we aim to add interactive tools for cares to practice implementing what they had learnt from the website in their day-to-day lives. It will include psychoeducation and training exercises about bipolar disorder and its treatment, strategies to help communicate and care for the person with bipolar disorder, personal stress management, and strategies to enhance personal wellbeing. Carer participants will have unlimited access to the website for 13 weeks and will be asked to access sections that are relevant to them and to provide fortnightly feedback.
(5) As part of the trial, participants will also complete the following fortnightly online assessments: the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (QLESQ-SF), the Depression Anxiety and Stress Scale (DASS), and the study-specific feedback survey. In addition, if the carer participant has a diagnosis of bipolar disorder (determined by the Structured Clinical Interview for DSM-5), they will also complete (1) item 10 of the Montogomery Åsberg Rating Scale (MADRS) and (2) the Altman Mania Scale for risk. They will receive automated reminder messages to complete the online assessments. If a carer participant does not complete the online assessment, the researcher will send up to three reminder messages.
Intervention code [1] 314759 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320431 0
A composite outcome for participants with bipolar disorder: Acceptability of the group intervention and app, measured using brief feedback surveys designed specifically for this study.
Timepoint [1] 320431 0
A composite outcome for participants with bipolar disorder: At the conclusion of all individual and group sessions (week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
Primary outcome [2] 320432 0
Participants with bipolar disorder: Helpfulness of the sessions, measured using the Helpful Aspects of Therapy Form (HAT)
Timepoint [2] 320432 0
Participants with bipolar disorder: At the conclusion of all individual and group sessions (week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
Primary outcome [3] 320433 0
A composite outcome for participants with bipolar disorder: Usefulness of the group intervention and the app, measured using a one hour, semi-structured interview (feedback interview) designed specifically for this study.
Timepoint [3] 320433 0
A composite outcome for participants with bipolar disorder: One week post-intervention (week 14)
Secondary outcome [1] 371568 0
Participants with bipolar disorder: Change in severity of mood symptoms, measured using the Montgomery Asberg Depression Scale (MADRS)
Timepoint [1] 371568 0
Participants with bipolar disorder: Conducted at baseline (week 0), all individual sessions (week 2, 3, 7, 9, 12) and week 14 (1 week post-intervention)
Secondary outcome [2] 371569 0
Participants with bipolar disorder: Change in mania symptomatology, measured using the Young Mania Rating Scale (YMRS)
Timepoint [2] 371569 0
Participants with bipolar disorder: Conducted at baseline (week 0), all individual sessions (week 2, 3, 7, 9, 12) and week 14 (1 week post-intervention)
Secondary outcome [3] 371570 0
Participants with bipolar disorder: Change in social and occupational impairment, measured using the Range of Impaired Functioning Tool (LIFE-RIFT)
Timepoint [3] 371570 0
Participants with bipolar disorder: Conducted at baseline (week 0), all individual sessions (week 2, 3, 7, 9, 12) and week 14 (1 week post-intervention)
Secondary outcome [4] 371571 0
Participants with bipolar disorder: Change in functional impairment, measured using the Functioning Assessment Short Form (FAST)
Timepoint [4] 371571 0
Participants with bipolar disorder: Conducted at baseline (week 0), all individual sessions (week 2, 3, 7, 9, 12) and week 14 (1 week post-intervention)
Secondary outcome [5] 371572 0
Participants with bipolar disorder: Change in self-rated depressive symptoms, measured using the Quick Inventory of Depressive Symptomatology (QIDS SR-16)
Timepoint [5] 371572 0
Participants with bipolar disorder: Conducted at baseline (week 0) and all group sessions (week 1, 4, 5, 6, 8, 10, 11, 13)
Secondary outcome [6] 371573 0
Participants with bipolar disorder: Change in self-rated mania symptomatology, measured using the Altman Self-Rating Mania Scale (ASRM)
Timepoint [6] 371573 0
Participants with bipolar disorder: Conducted at baseline (week 0) and all group sessions (week 1, 4, 5, 6, 8, 10, 11, 13)
Secondary outcome [7] 371575 0
Participants with bipolar disorder: Change in self-rated quality of life, measured using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (QLESQ-SF)
Timepoint [7] 371575 0
Participants with bipolar disorder: Conducted at baseline (week 0) and all group sessions (weeks 1, 4, 5, 6, 8, 10, 11, 13)
Secondary outcome [8] 371576 0
Participants with bipolar disorder: Change in self-rated anxiety and stress symptomatology, measured using the Depression and Ansxiety and Stress Scale (DASS-21: Anxiety and Stress Scales)
Timepoint [8] 371576 0
Participants with bipolar disorder: Conducted at baseline (week 0) and all group sessions (weeks 1, 4, 5, 6, 8, 10, 11, 13)
Secondary outcome [9] 371740 0
A composite outcome for carer participants: Acceptability, relevance, usability, and perceived usefulness of the optional online carer resource, measured using a brief online feedback survey designed specifically for this study.
Timepoint [9] 371740 0
A composite outcome for carer participants: Conducted at weeks 4, 8, and 12.
Secondary outcome [10] 371741 0
Carer participants: Usefulness of the optional online carer resource, measured using a one hour, semi-structured interview (feedback interview) in week 13 designed specifically for this study.
Timepoint [10] 371741 0
Carer participants: Conducted in week 13
Secondary outcome [11] 372072 0
Carer participants: Change in severity of mood symptoms, measured using the Montgomery Asberg Depression Scale (MADRS)
Timepoint [11] 372072 0
Carer participants: Conducted at baseline (week 0) and week 13
Secondary outcome [12] 372073 0
Carer participants: Change in mania symptomatology, measured using the Young Mania Rating Scale (YMRS)
Timepoint [12] 372073 0
Carer participants: Conducted at baseline (week 0) and week 13
Secondary outcome [13] 372074 0
Carer participants: Change in functional impairment, measured using the Functioning Assessment Short Form (FAST)
Timepoint [13] 372074 0
Carer participants: Conducted at baseline (week 0) and week 13
Secondary outcome [14] 372075 0
Carer participants: Change in self-rated quality of life, measured using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (QLESQ-SF)
Timepoint [14] 372075 0
Carer participants: Conducted at baseline (week 0), week 1, week 2 and fortnightly thereafter (week 4, 6, 8, 10, 12)
Secondary outcome [15] 372076 0
Carer participants: Change in self-rated depression, anxiety and stress symptomatology, measured using the full Depression and Anxiety and Stress Scale (DASS-21)
Timepoint [15] 372076 0
Carer participants: Conducted at baseline (week 0), week 1, week 2, and fortnightly thereafter (week 4, 6, 8, 10, 12)
Secondary outcome [16] 372077 0
Carer participants with bipolar disorder (determined by an initial SCID-5-RV assessment): Change in suicide risk, measured using item 10 on the MADRS
Timepoint [16] 372077 0
Carer participants with bipolar disorder (determined by an initial SCID-5-RV assessment): Conducted at week 1, week 2, and and fortnightly thereafter (week 4, 6, 8, 10, 12)
Secondary outcome [17] 372078 0
Carer participants with bipolar disorder (determined by an initial SCID-5-RV assessment): Change in self-rated mania symptomatology, measured using the Altman Self-Rating Mania Scale (ASRM)
Timepoint [17] 372078 0
Carer participants with bipolar disorder (determined by an initial SCID-5-RV assessment): Conducted at week 1, week 2, and and fortnightly thereafter (week 4, 6, 8, 10, 12)

Eligibility
Key inclusion criteria
All participants must:
1. Be able to speak, read, write and understand the English language

2. Have access to a mobile phone, iPad or computer

3. Have the capacity to consent to the study and comply with study procedures

Participants with bipolar disorder must:
1. Have a diagnosis of bipolar disorder using the Structured Clinical Interview for DSM-5 (SCID-5-RV).

2. Have subsyndromal levels of depression with a MADRS score between 7 and 19

3. Currently be receiving treatment for bipolar disorder from a medical practitioner

4. Nominate a current treating medical practitioner that can be contacted if the researchers become concerned about the person's welfare

Carer participants must:
1. Identify as a key informal support person, and family member, friend or partner of an adult with diagnosed bipolar disorder.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All participants will be excluded if they are:
1. Currently suicidal, determined by a score of 5 or greater on the MADRS Item 10

2. Currently experiencing a significant depressive episode, determined by a score of 20 or greater on the MADRS

3. Currently experiencing acute mania or hypomania, determined by a score of 12 or greater on the Young Mania Rating Scale

4. Participants who are currently psychotic, indicated by the SCID-5-RV

5. Participants with a physical or neurological disorder that will impair their ability to participate fully or give informed consent (e.g. dementia)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Due to practical concerns, we aim to include a small sample of people with bipolar disorder (n=16) and carers (n=6). This sample will still be sufficient to help us evaluate the intervention, taking into account the possibility of some drop-out.

Open-ended responses to the feedback survey and the feedback interview will be analysed broadly with reference to Braun and Clarke’s (2006) thematic approach integrated with elements of grounded analysis. To establish themes directly from participants' responses, we will follow Charmaz's (2006) coding method. Closed-ended responses to the feedback survey will be analysed by calculating simple percentages. Two researchers will independently review the data from the feedback survey and determine whether their results are similar or different, A post-intervention interview with participants will further clarify and corroborate these results.

Descriptive statistics and univariate tests will be used to explore participants characteristics and outcome measures, specifically with regard to improvements in depressive symptoms, functioning and QOL, but also changes in manic symptoms. Acute episodes (determined by our symptom scales) or an adverse event (in the context of an acute episode) will be totalled to determine the number of participants who relapsed while receiving the intervention.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
31/08/2025
Actual
Sample size
Target
22
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 14006 0
The Geelong Clinic - St Albans Park
Recruitment hospital [2] 14007 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 26785 0
3219 - St Albans Park
Recruitment postcode(s) [2] 26786 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 303053 0
Government body
Name [1] 303053 0
The Acceleration Fund of the Department of Health and Human Services
Country [1] 303053 0
Australia
Funding source category [2] 303054 0
Commercial sector/Industry
Name [2] 303054 0
Healthscope
Country [2] 303054 0
Australia
Funding source category [3] 303055 0
University
Name [3] 303055 0
Deakin University
Country [3] 303055 0
Australia
Primary sponsor type
Hospital
Name
Barwon Health
Address
Research Ethics, Governance and Integrity (REGI) Unit
PO BOX 281
Geelong, Victoria 3220
Country
Australia
Secondary sponsor category [1] 303036 0
None
Name [1] 303036 0
Address [1] 303036 0
Country [1] 303036 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303605 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 303605 0
Ethics committee country [1] 303605 0
Australia
Date submitted for ethics approval [1] 303605 0
24/01/2018
Approval date [1] 303605 0
19/07/2018
Ethics approval number [1] 303605 0
17/190

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

Contacts
Principal investigator
Name 94230 0
Dr Lesley Berk
Address 94230 0
Deakin University
IMPACT SRC
PO BOX 281
Geelong, Victoria, 3220
Country 94230 0
Australia
Phone 94230 0
+61342153324
Fax 94230 0
Email 94230 0
[email protected]
Contact person for public queries
Name 94231 0
Lesley Berk
Address 94231 0
Deakin University
IMPACT SRC
PO BOX 281
Geelong, Victoria, 3220
Country 94231 0
Australia
Phone 94231 0
+61342153324
Fax 94231 0
Email 94231 0
[email protected]
Contact person for scientific queries
Name 94232 0
Lesley Berk
Address 94232 0
Deakin University
IMPACT SRC
PO BOX 281
Geelong, Victoria, 3220
Country 94232 0
Australia
Phone 94232 0
+61342153324
Fax 94232 0
Email 94232 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?
• Participant data supporting the publication results
• Participant data relating to primary outcomes
Note: All data will be de-identified.
When will data be available (start and end dates)?
Data will be available 3 months after publication.
Data will be available for an indefinite time.
Start date: Approximately 2025 – 2026.
End date: Unknown
Available to whom?
Data are potentially available to:
• Other: Researchers from research organisations (e.g., universities, institutes, or not-for-profit organisations) on a case-by-case basis.
Based in:
• Any location

Further information: All data requests will be considered by the principal investigator on a case-by-case basis and must be approved by the Sponsor (Barwon Health REGI). Requests must include a methodologically sound proposal and data analysis plan. Specific conditions of use may apply and will be specified in a data agreement that the requester must agree to before access to the data is granted. For more information, please refer to Deakin University’s Research data management procedure.
Available for what types of analyses?
Data are potentially available for analyses
• Assessed on a case-by-case basis
How or where can data be obtained?
When data becomes available, access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health). Search for the ACTRN number (ACTRN12619001179123) or the trial acronym (BipolarWISE) in the catalogue to find datasets associated with this trial. For more information, please refer to Deakin University’s Research data management procedure.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23791Study protocol    To be uploaded once complete
23792Data dictionary    To be uploaded once complete



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.