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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
20/08/2019
Date data sharing statement initially provided
20/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of MyMAPS – a program about living well with bipolar disorder
Scientific title
A pilot study to assess the acceptability of MyMAPS, an innovative blended face-to-face and mobile application psychosocial intervention for adults with bipolar disorder
Secondary ID [1] 298508 0
None
Universal Trial Number (UTN)
U1111-1235-6790
Trial acronym
MyMAPS
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
MyMAPS includes: (1) an adjunctive 13-session (5 individual, 8 group) face-to-face psychosocial treatment intervention for adults with bipolar disorder supplemented with (2) a mobile/web application for adults with bipolar disorder; and (3) an optional online, psychoeducational carer resource that will be piloted for 13 weeks to determine the acceptability and usefulness of the intervention.

1. The 13 week psychosocial intervention is developed and will be run by clinical researchers who have extensive clinical and research experience and have developed and trialled successful interventions for bipolar disorder. It combines psychoeducation with cognitive behavioural therapy training exercises and integrates approaches shown to assist with subysndromal depressive symptoms, mood stability and stress reduction, including mindfulness and wellbeing therapy. The content of the training sessions includes individual orientation and welcome to the intervention, psychoeducation about bipolar disorder, treatment, helpful coping strategies and making plans to gain more control over the disorder and reduce subsyndromal depressive symptoms, stress and trigger management, lifestyle regulation and ways to enhance wellbeing. The eight face-to-face group sessions (week 1, 4, 5, 6, 8, 10, 11, 13) will run for 90 minutes with a break midway. There are two research facilitators per group (maximum 8 participants). Group sessions focus on providing psychoeducation and training (as mentioned above), using brainstorming, role-plays and video examples based on research evidence. Learning and reinforcement of skills will be enhanced by creating a safe and supportive peer environment, stressing universality, group cohesiveness, acceptance and validation. The five individual face-to-face sessions week 2, 3, 7, 9, 12) will run for 50-60 minutes. The aim of the individual sessions is for the trained health professional facilitator to orientate, engage and assist the participant to personalise the intervention to their needs. There is a focus on assisting participants to develop and track individual SMART (Specific, Measurable, Attainable, Relevant and Timely) goals related to the intervention content. They will be assisted to use the MyMAPS app (see below) during these sessions. As part of the intervention, and to enhance engagement and retention, all participants will receive a brief, weekly, personalised messages (between face-to-face sessions) from the research facilitators via the secure app messaging system. These messages will have a few words of encouragement and, when appropriate, direct participants to app content that may be useful to them. Participants will also receive automated reminder messages to attend the face-to-face groups and individual sessions. We will also monitor and report on session attendance, attrition and participant use of the app.
2. The MyMAPS App (available only to participants with bipolar) aims to reinforce practice of positive illness management and wellbeing strategies. It will include psychoeducation content and exercises from the face-to-face sessions. There is also a tracking component to help participants monitor and respond to depressive symptoms, mood changes, early warning signs, triggers, deal with stress, lifestyle difficulties (e.g. sleep problems) and manage bipolar disorder crises. They can enter a list of their emergency and support contacts on the app for easy access in a crisis . The psychoeducation information discussed in the face-to-face sessions is available as “articles” on the app. The app tools are study-specific exercises in the form of easy to complete survey activities (e.g. monitoring my warning signs and setting a SMART goal to use positive coping strategies from their plans to manage warning signs when necessary) based on models of psychotherapy. Use of these tools is not compulsory although it will be encouraged via automated reminders (at a frequency determined by the user). The facilitator will assist participants to learn how to use the app, encourage use, and troubleshoot problems during the individual sessions. The same information and exercises, will however be available in hardcopy if a participant has difficulty with app.
3. The carer component of MyMAPS is separate from the rest of the MyMAPS intervention in that carers have their own independent online resource. It will be an upgraded and privately accessible version of www.bipolarcaregivers.org, which 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. 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
Gender
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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
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
Address [1] 303053 0
50 Lonsdale Street
Melbourne, Victoria 3000
Country [1] 303053 0
Australia
Funding source category [2] 303054 0
Commercial sector/Industry
Name [2] 303054 0
Healthscope
Address [2] 303054 0
312 St Kilda Road
Melbourne, Victoria 3004
Country [2] 303054 0
Australia
Funding source category [3] 303055 0
University
Name [3] 303055 0
Deakin University
Address [3] 303055 0
IMPACT SRC
PO BOX 281
Geelong, Victoria, 3220
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
Research Ethics, Governance and Integrity (REGI) Unit
PO BOX 281
Geelong, Victoria, 3220
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
The aim of this study is to develop an acceptable, useful, and practical training program, MyMAPS, to assist adults with bipolar disorder to manage their condition and enhance their quality of life. MyMAPS is a blended online (app) and face-to-face intervention with an optional website component for adult family members/friends who support a person with bipolar disorder and would like to better understand and deal with the disorder and maintain their own wellbeing. The feedback from participants will assist in refining the final program which we aim to test in a large trial. If it is effective, the program can be disseminated to those affected by bipolar disorder.
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
l.berk@deakin.edu.au
Contact person for public queries
Name 94231 0
Dr 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
l.berk@deakin.edu.au
Contact person for scientific queries
Name 94232 0
Dr 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
l.berk@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results