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Development of BipolarWISE, an innovative online psychosocial intervention

Development of BipolarWISE – a program about living well with bipolar disorder

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001179123
Acronym
BipolarWISE
Enrollment
15
Registered
2019-08-20
Start date
2024-08-30
Completion date
2025-11-12
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to develop an acceptable, useful, and practical training program, BipolarWISE, to assist adults with bipolar disorder to manage their condition and enhance their quality of life and an information app for carers. The BipolarWISE program involves an online group and individual intervention with an optional web app component for adults with bipolar disorder. BipolarASSIST is the carer part of the BipolarWISE study. It involves the development and formative evaluation of an app for close family, partners and friends of people with bipolar disorder to assist them to maintain their own wellbeing, and be informed about bipolar disorder, treatments, resources and ways to consider supporting the person with bipolar disorder in different stages of illness and wellness. The feedback from participants will assist in refining the program for people with bipolar disorder and their family and friends, which we aim to test in a large trial. If it is effective, the program can be disseminated to those affected by bipolar disorder.

Interventions

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 individua

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.

The BipolarWISE program involves: (1) Ten group sessions with a maximum of eight 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 session

The BipolarWISE program involves: (1) Ten group sessions with a maximum of eight 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 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 a month and will be asked to access sections that are relevant to them and to provide feedback at the end of the month. (5) The main aim of the study is to obtain feedback on the acceptability, usefulness and relevance of the interventions and how they can be improved. Participants with bipolar disorder will be asked to complete feedback surveys after each group session, as well as a final feedback interview. They will also complete mood assessments (BDRS, YMRS) and the Functioning Assessment Short Form (FAST) mid and post intervention. As part of the carer trial, participants will be asked to complete a feedback interview and online assessments: Quick Inventory of Depressive Symptoms (QIDS-SR), the Generalised Anxiety Disorder 7 item scale (GAD-7) and Carer related quality of life scale (Carer Qol). In addition, if the carer participant may have bipolar disorder (determined by clinical interview and the Mood Disorders Questionnaire),the Altman Mania Scale for risk. Carer participants will receive automated reminder messages to complete the online assessments. If a participant does not complete the online assessment, the researcher will send up to three reminder messages.

Sponsors

Barwon Health
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 23, 2026