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Trial registered on ANZCTR


Registration number
ACTRN12617000840381
Ethics application status
Approved
Date submitted
5/06/2017
Date registered
7/06/2017
Date last updated
21/06/2019
Date data sharing statement initially provided
21/06/2019
Date results information initially provided
21/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing decision-making about treatment in bipolar II disorder: Evaluation of a treatment decision-aid for patients and their family.
Scientific title
Phase II randomised controlled trial evaluation of treatment decision-aid for patients with bipolar II disorder and their family considering treatment options for relapse prevention.
Secondary ID [1] 289850 0
Nil known
Universal Trial Number (UTN)
U1111-1186-0652
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Bipolar II disorder 299788 0
Condition category
Condition code
Mental Health 299716 299716 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment decision-aid intervention: This decision-aid website for bipolar II disorder, developed by PI Juraskova, CIs and professional web designers/developers, has been informed by: best available clinical evidence; extensive qualitative interviews with key stakeholders (patients [n=28], family [n=13], and clinicians [n=20]) (Fisher et al., 2017a; 2017b; 2017c); iterative review by an expert advisory group (decision-aid experts, patients with bipolar II disorder, their family and treating clinicians); and International Patient Decision Aid Standards (IPDAS). It provides evidence-based, non-directional information, which has been professionally-copy edited for low health literacy levels. The decision-aid explains main available medication and psychological treatment options for relapse prevention in bipolar II disorder, based on available guidelines; with specific sections for patients’ family. Lay information is presented using text and graphics on the rationale for, efficacy and known benefits/costs of each treatment option. Interactive values clarification exercises are included to assist patients/family to consider their preferences and deliberate on the benefits/costs of the different treatment options. The decision-aid website can be accessed by the patient participant and/or family member at any frequency and duration in the period following diagnosis and leading up to follow-up consultation/s with their managing psychiatrist, GP and/or clinical psychologist. The website will be used for informed treatment decisions insofar as it is designed to increase patients' knowledge about their main available treatment options and guide them through a deliberate process of weighing up the "pros" and the "cons" of options in line with their personal values and preferences (via the interactive, values, clarification exercises). Patients (and their families) will have the option to save/print their values clarification responses and take these along to follow-up consultations with clinicians to serve as a "conversation starter". Adherence to the intervention will be tracked via Analytics software (e.g., page views, time spent on page, downloads etc.). Moreover adherence/fidelty will be maintained via "essential reading sections"; these are information sections of the website that will need to be consulted before the participant can proceed to the values clarification exercises and completion of the questionnaires.

Fisher A et al. (2017a). A qualitative exploration of patient and family views and experiences of treatment decision-making in bipolar II disorder. Journal of Mental Health (Epub:13 January 2017). doi: http://dx.doi.org/10.1080/09638237.2016.1276533

Fisher et al. (2017b). A qualitative exploration of clinician views and experiences of treatment decision-making in bipolar II disorder. Community Mental Health Journal (Epub: 19 January 2017). doi: 10.1007/s10597-016-0077-4

Fisher A et al., (2017c) Identifying and addressing barriers to treatment decision-making in bipolar II disorder: Clinicians’ perspective. Australian Psychologist (Epub: 14 February 2017) doi:10.1111/ap.12264.



Intervention code [1] 295529 0
Treatment: Other
Comparator / control treatment
Usual care/attention control will comprise: any information materials (e.g., factsheets) that patients are already routinely provided with, or advised to consult during their appointment at the Black Dog Institute (recruitment site); and the existing Black Dog Institute webpages on treatments for bipolar disorder: (www.blackdoginstitute.org.au/public/bipolardisorder/treatments/).
Control group
Active

Outcomes
Primary outcome [1] 299168 0
Decisional conflict (i.e., feeling certain/confident about decided-on course of action, feeling well informed, well supported and clear about values).

This composite primary outcome measure will be assessed via the validated self-report questionnaire: The Decisional Conflict Scale (O'Connor, 1995).
Timepoint [1] 299168 0
Immediately post-treatment decision (T1)
3 months' post-treatment decision follow-up (T2)
Secondary outcome [1] 326400 0
Knowledge about treatment options and outcomes

Composite secondary outcome measure assessed via a questionnaire designed specifically for this study.
Timepoint [1] 326400 0
Immediately post-treatment decision (T1)
3 months' post-treatment decision follow-up (T2)
Secondary outcome [2] 326401 0
Concordance between preferred/actual levels of decision-making involvement

This secondary outcome will be assessed via the agreement between patient ratings of their preferred and actual levels of decision-making involvement on the validated self-report questionnaire: The Control Preferences Scale (Degner, 1997).
Timepoint [2] 326401 0
Immediately post-treatment decision (T1)
3 months' post-treatment decision follow-up (T2)
Secondary outcome [3] 326402 0
Informed, values-based treatment choices.

This secondary outcome measure will be assessed via an adapted version of Marteau et al's (2001) self-report Measure of Informed Choice, designed specifically for this study.
Timepoint [3] 326402 0
Immediately post-treatment decision (T1)
Secondary outcome [4] 326403 0
Preparation for decision-making

This secondary outcome measure will be assessed via the validated self-report questionnaire: The Preparation for Decision-making Scale (Bennett et al., 2010).
Timepoint [4] 326403 0
Immediately post-treatment decision (T1)
Secondary outcome [5] 326404 0
Decisional regret

This secondary outcome measure will be assessed via the validated self-reported questionnaire: The Decision Regret Scale (Brehaut et al., 2003).
Timepoint [5] 326404 0
3 months' post-treatment decision follow-up (T2)
Secondary outcome [6] 326405 0
Uptake of effective treatment options

This secondary outcome measure will be assessed via self-report on a questionnaire specifically designed for this study. Participants who indicate uptake of one or more of the medication and psychological treatment options indicated in the decision-aid will be said to have taken up effective treatment options.
Timepoint [6] 326405 0
Immediately post-treatment decision (T1)
Secondary outcome [7] 335714 0
Understanding of treatment options and outcomes

This secondary outcome measure will be assessed via a questionnaire designed specifically for this study.
Timepoint [7] 335714 0
Immediately post-treatment decision (T1)
3 months' follow-up (T2)
Secondary outcome [8] 335720 0
Symptom Severity (used as an index of safety).

This secondary outcome will be assessed via a validated self-report questionnaire: The Internal States Scale (Bauer et al., 1991).
Timepoint [8] 335720 0
Immediately post-treatment decision (T1)
3 months' follow-up (T2).
Secondary outcome [9] 335721 0
Medication Adherence (used as an index of safety).

This secondary outcome will be assessed via validated self-report questionnaire: The Morisky Medication Adherence Scale (MMAS-8).
Timepoint [9] 335721 0
Immediately post-treatment decision (T1)
3 months' follow-up (T2).
Secondary outcome [10] 343581 0
State anxiety. This secondary outcome will be assessed via a validated self-report questionnaire: the short-form of the State-Trait Anxiety Inventory state scale (Marteau & Bekker, 1992) .

Timepoint [10] 343581 0
Immediately post-treatment decision (T1); and 3-months' follow-up (T3)
Secondary outcome [11] 343582 0
Participant feedback on DA (e.g., perceived ease of use, usefulness, attitudes towards using/user acceptance, and trustworthiness and balance of information) will be assessed via an adapted 24-item questionnaire based on the Technology Acceptance Measure (Davis, 1989).

This measure also asks about the extent to which participants actually accessed the DA website.

Timepoint [11] 343582 0
Immediately post-treatment decision (T1)

Eligibility
Key inclusion criteria
i) Confirmed clinical diagnosis of bipolar II disorder;
ii) Out of acute episode of depression and/or hypomania (i.e., subsyndromal or euthymic);
iii) Actively considering treatment options for relapse prevention in bipolar II disorder with a clinician (e.g., GP, psychiatrist or clinical psychologist).
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Lacks English proficiency to read the decision-aid and/or complete questionnaires;
ii) Lacks capacity to provide informed consent to research;
iii) Comorbid substance abuse disorder;
iv) Comorbid neurological or major psychiatric condition.

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)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated via an inbuilt site-generated random sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Pre-/post-design with 1:1 randomisation of individual patients.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Planned statistical analyses will follow the intention-to-treat principle. Descriptive statistics will assess sample characteristics, decision-aid perceptions and any potential decision-aid differences on symptom severity and medication adherence at T1/T2 (safety). Linear and logistic regressions will determine DA effects at T1/T2 on continuous and binary outcomes, respectively. Adjusted models will control for baseline (T0) variables identified a-priori as potential covariates (e.g., medical training, time-since-diagnosis).

Recruitment
Recruitment status
Active, not 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)
NSW
Recruitment hospital [1] 6686 0
Black Dog Institute - Randwick
Recruitment postcode(s) [1] 14316 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 294224 0
University
Name [1] 294224 0
University of Sydney
Address [1] 294224 0
School of Psychology
Brennan MacCallum Building (A18)
University of Sydney,
Camperdown, NSW, 2006.
Country [1] 294224 0
Australia
Funding source category [2] 296675 0
Charities/Societies/Foundations
Name [2] 296675 0
Australian Rotary Health
Address [2] 296675 0
Address:
2nd Floor, 43 Hunter Street,
Parramatta NSW 2150

Postal Address:
PO Box 3455,
Parramatta NSW 2124
Country [2] 296675 0
Australia
Primary sponsor type
Individual
Name
A/Prof Ilona Juraskova
Address
School of Psychology,
Brennan MacCallum Building (A18),
University of Sydney,
Camperdown, NSW, 2006.
Country
Australia
Secondary sponsor category [1] 293056 0
University
Name [1] 293056 0
University of Sydney
Address [1] 293056 0
School of Psychology
Brennan MacCallum Building (A18)
University of Sydney,
Camperdown, NSW, 2006
Country [1] 293056 0
Australia
Other collaborator category [1] 279144 0
Other Collaborative groups
Name [1] 279144 0
Black Dog Institute
Address [1] 279144 0
Hospital Road,
Randwick, NSW, 2052.
Country [1] 279144 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295646 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 295646 0
The University of Sydney,
NSW, 2006
Ethics committee country [1] 295646 0
Australia
Date submitted for ethics approval [1] 295646 0
05/09/2016
Approval date [1] 295646 0
27/09/2016
Ethics approval number [1] 295646 0
2016/763
Ethics committee name [2] 296106 0
The Black Dog Institute Research Advisory Committee
Ethics committee address [2] 296106 0
Hospital Road,
Randwick, NSW, 2031
Ethics committee country [2] 296106 0
Australia
Date submitted for ethics approval [2] 296106 0
01/08/2016
Approval date [2] 296106 0
09/08/2016
Ethics approval number [2] 296106 0
2016011 Fisher

Summary
Brief summary
A diagnosis of bipolar II disorder is commonly accompanied by a need to make complex treatment decisions about medications and adjunctive psychological therapies, often for lifetime prophylactic (preventative) use. However, people with bipolar II disorder are often reluctant to commence and adhere to effective medications long-term, mostly due to lack of knowledge, less-than-desired involvement and preference for treatments other than those prescribed, which can worsen the course of their illness. Research shows that many people with bipolar II disorder, especially those with a recent diagnosis, prefer a more active role in their treatment decisions than they currently have, and may have greater unmet decision-making needs than those with a longer-standing diagnosis. Yet, there is currently no resource that might facilitate this involvement. This project aims to build on our comprehensive research program targeting bipolar II disorder treatment decision-making by evaluating the world’s first, evidence-based online decision-support resource, a decision-aid website, for patients with bipolar II disorder and their family who are deciding on treatment options for relapse prevention. In this Phase II randomised control trial, a consecutive patient sample (n=60) aged 18+ and with a confirmed clinical diagnosis of bipolar II disorder will be recruited through the Black Dog Institute and randomised (1:1) to receive either usual care with or without the decision-aid. At baseline, immediately post-treatment decision and at 3 months' follow-up, we will assess, via validated and purpose-designed questionnaires, the decision-aid's potential efficacy at improving key aspects of decision-making quality. We expect that the DA will: i) reduce patients' uncertainty and regret in decision-making, ii) empower them to feel more informed and supported in decision-making, iii) help clarify their values regarding for treatment for bipolar II disorder, iv) improve their knowledge about treatment options/outcomes, v) help them to be involved in treatment decision-making to the extent desired, and vi) improve their uptake of effective medication and psychological treatments.
Trial website
www.bipolardecisionaid.com.au
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 68010 0
A/Prof Ilona Juraskova
Address 68010 0
School of Psychology,
Brennan MacCallum Building (A18),
University of Sydney,
Camperdown, NSW, 2006.
Country 68010 0
Australia
Phone 68010 0
+61 2 9351 6811
Fax 68010 0
+61 2 9036 5292
Email 68010 0
ilona.juraskova@sydney.edu.au
Contact person for public queries
Name 68011 0
Dr Alana Fisher
Address 68011 0
School of Psychology,
Brennan MacCallum Building (A18),
University of Sydney, NSW, 2006.
Country 68011 0
Australia
Phone 68011 0
+61 2 9036 9258
Fax 68011 0
+61 2 9036 5292
Email 68011 0
a.fisher@sydney.edu.au
Contact person for scientific queries
Name 68012 0
A/Prof Ilona Juraskova
Address 68012 0
School of Psychology,
Brennan MacCallum Building (A18),
University of Sydney, NSW, 2006.
Country 68012 0
Australia
Phone 68012 0
+61 2 9351 6811
Fax 68012 0
+61 2 9036 5292
Email 68012 0
ilona.juraskova@sydney.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
No ethics approved provisions for this.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 2411 0
Study protocol
Citation [1] 2411 0
Link [1] 2411 0
Email [1] 2411 0
Other [1] 2411 0
https://doi.org/10.1016/j.conctc.2018.11.004
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary