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Trial registered on ANZCTR


Registration number
ACTRN12610001002077
Ethics application status
Approved
Date submitted
15/11/2010
Date registered
17/11/2010
Date last updated
8/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Wellbeing Group Program for Adults Recently Diagnosed with Bipolar II Disorder
Scientific title
A Randomised Controlled Trial of a Wellbeing Group Program Versus Treatment as Usual for Adults Recently Diagnosed with Bipolar II Disorder
Secondary ID [1] 253090 0
N/A
Universal Trial Number (UTN)
U1111-1118-1490
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar disorder 258651 0
Condition category
Condition code
Mental Health 258789 258789 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the Wellbeing Group Program will receive an 8-session program (which will run over 8 weeks) as summarised below: Session 1: Introduction to the group process including introduction of group members, group requirements and a brief introduction to bipolar disorder, Wellbeing Plans and mood monitoring; Session 2: An understanding of bipolar disorder, identification of early warning signs and symptoms, identifying relapse signatures, and understanding suicide risk and stressors that tend to trigger episodes; Session 3: Early detection of episodes, medication adherence, the dangers of alcohol and substance abuse, and the identification of related wellbeing strategies and personal resources; Session 4: Dealing with stress and life pressures, including the use of mindfulness and relaxation strategies and the development of contingency plans; Session 5: Developing happiness and healthy lifestyle strategies, the incorporation of these into the Wellbeing Plan, and the final development of the Plan; Session 6: Involving the family/carers in the Wellbeing Plan; Session 7: Assessing progress, reviewing resources available, adapting Wellbeing Plans to recent developments; Session 8: Final review of Wellbeing Plans, evaluation of group process, addressing issues that have arisen. Each group session will run for approximately 90 minutes and the general structure of each session is as follows: 20-30 minutes – discussion about how participants have been over the previous week and how they have progressed with their Wellbeing Plans (based on what activities they were required to complete the previous week); 30-35 minutes – presentation and discussion of the current session material; 30-35 minutes – incorporation of the session material discussed into the Wellbeing Plan and setting activities to complete over the coming week. All material will be presented to group members through oral presentation (and where relevant, Powerpoint presentation) and group discussion. Participants will also receive a booklet containing relevant information pertaining to the material covered in each session.
Intervention code [1] 257608 0
Lifestyle
Intervention code [2] 257609 0
Treatment: Other
Comparator / control treatment
Participants assigned to the control arm of the study will continue treatment as usual with their treating team as normal. During the same 8-week time period that the treatment arm will be receiving the Wellbeing Group Program, those assigned to the control condition will monitor their moods and continue treatment as usual. Although it is not known exactly what will constitute "treatment as usual" for the control group, participants may be receiving regular input from a general pracititoner, psychiatrist, psychologist/counsellor or other health professional. The treating team is not associated with the study.
Control group
Active

Outcomes
Primary outcome [1] 259660 0
Primary Outcome: Level of social and occupational functioning.

Primary Outcome Measure: Work and Social Adjustment Scale (Mundt, Marks, Shear & Greist, 2002) - 6-item scale measuring impairment due to bipolar disorder in a number of life domains including work, home management, social life, private leisure activities, relationships and overall functioning.
Timepoint [1] 259660 0
Baseline (1 week pre-group), 1 week post-group, and 1-month, 2-months, 3-months and 4-months post-group follow-up. Note: Post-group assessments occur at the completion of the 8-week intervention phase (either the Wellbeing Group Program for the treatment arm or a mood monitoring period for the control arm) at the time intervals stated above.
Secondary outcome [1] 266342 0
Secondary Outcome: Episode occurrence

Secondary Outcome Measure: Episode History and Characteristics Survey (Developed for this study) - Assesses episode occurrence and severity and health services utilisation.

Secondary Outcome Measure: Daily Mood Monitoring Chart (Parker, Tully, Olley & Hadzi-Pavlovic, 2006) - monitors mood and episode occurrence and severity, general functional impairment and the occurrence of life events in a time sensitive manner.
Timepoint [1] 266342 0
Baseline, 1 week post-group, and 1-month, 2-months, 3-months and 4-months post-group follow-up. Note: Post-group assessments occur at the completion of the 8-week intervention phase (either the Wellbeing Group Program for the treatment arm or a mood monitoring period for the control arm) at the time intervals stated above.
Secondary outcome [2] 266343 0
Secondary Outcome: Medication adherence

Sceondary Outcome Measure: Medication Adherence Items (Developed for this study) - measures medication adherence and reasons for noncompliance.
Timepoint [2] 266343 0
Baseline (1 week pre-group), 1 week post-group, and 1-month, 2-months, 3-months and 4-months post-group follow-up. Note: Post-group assessments occur at the completion of the 8-week intervention phase (either the Wellbeing Group Program for the treatment arm or a mood monitoring period for the control arm) at the time intervals stated above.
Secondary outcome [3] 266344 0
Secondary Outcome: Level of substance use

Secondary Outcome Measure: Level of Substance Use Survey (Developed for this study) - Measure of substance use over lifetime as well as in the past 2-4 months.
Timepoint [3] 266344 0
Baseline (1 week pre-group), 1 week post-group and 4-months post-group follow-up. Note: Post-group assessments occur at the completion of the 8-week intervention phase (either the Wellbeing Group Program for the treatment arm or a mood monitoring period for the control arm) at the time intervals stated above.
Secondary outcome [4] 266345 0
Secondary Outcome Measure (2): Quality of Life in Bipolar Disorder scale (Michalak & Murray, 2010) - 56-item scale measuring quality of life over the past 7 days for people diagnosed with bipolar disorder in 14 life domains.
Timepoint [4] 266345 0
Baseline (1 week pre-group), 1 week post-group, and 1-month, 2-months, 3-months and 4-months post-group follow-up. Note: Post-group assessments occur at the completion of the 8-week intervention phase (either the Wellbeing Group Program for the treatment arm or a mood monitoring period for the control arm) at the time intervals stated above.
Secondary outcome [5] 266346 0
Secondary Outcome: Perceptions of ability to manage highs and lows.

Secondary Outcome Measure: Perceptions of Management of Highs and Lows (Developed for this study) - measures level of confidence in ability to identify and effectively manage an episode.
Timepoint [5] 266346 0
Baseline (1 week pre-group), 1 week post-group, and 1-month, 2-months, 3-months and 4-months post-group follow-up. Note: Post-group assessments occur at the completion of the 8-week intervention phase (either the Wellbeing Group Program for the treatment arm or a mood monitoring period for the control arm) at the time intervals stated above.
Secondary outcome [6] 266371 0
Secondary Outcome: Episode severity

Secondary Outcome Measure: Episode History and Characteristics Survey (Developed for this study) - Assesses episode occurrence and severity and health services utilisation.

Secondary Outcome Measure: Daily Mood Monitoring Chart (Parker, Tully, Olley & Hadzi-Pavlovic, 2006) - monitors mood and episode occurrence and severity, general functional impairment and the occurrence of life events in a time sensitive manner.
Timepoint [6] 266371 0
Baseline, 1 week post-group, and 1-month, 2-months, 3-months and 4-months post-group follow-up. Note: Post-group assessments occur at the completion of the 8-week intervention phase (either the Wellbeing Group Program for the treatment arm or a mood monitoring period for the control arm) at the time intervals stated above.
Secondary outcome [7] 266372 0
Secondary Outcome: Health services utilisation

Secondary Outcome Measure: Episode History and Characteristics Survey (Developed for this study) - Assesses episode occurrence and severity and health services utilisation.
Timepoint [7] 266372 0
Baseline, 1 week post-group, and 1-month, 2-months, 3-months and 4-months post-group follow-up. Note: Post-group assessments occur at the completion of the 8-week intervention phase (either the Wellbeing Group Program for the treatment arm or a mood monitoring period for the control arm) at the time intervals stated above.

Eligibility
Key inclusion criteria
(1) Primary diagnosis of bipolar II disorder received up to 18 months ago with confirmation of the diagnosis through a diagnostic interview prior to inclusion in the study; (2) Age between 20-70 years; (3) Able to attend the Black Dog Institute in Randwick, NSW for 8 program sessions over an 8-week period; and (4) Able to understand, read and speak English adequately.
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Evidence of organic brain syndrome;
(2) Taken part in a Wellbeing Group Program or developed a Wellbeing Plan individually with a psychologist in the past 18 months.

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)
Once the randomisation sequence has been generated, an independent person not associated with the research will develop a set of sequentially numbered, sealed, opaque envelopes that contain the allocation sequence. The set will be kept at a location where the researcher responsible for the initial eligibility assessments and group assignments will not be able to access.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Restricted randomisation will facilitate allocation of enrolled participants into conditions. A random allocation sequence will be generated for blocks of 16 to 20 participants. The allocation sequence will take place using an electronic program and be performed by an independent person not associated with the research. Randomisation will not be stratified within each block by any participant characteristics.
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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258060 0
Government body
Name [1] 258060 0
Department of Health and Ageing
Country [1] 258060 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
School of Psychiatry and Black Dog Institute
Hospital Road,
Prince of Wales Hospital
Randwick NSW 2031, Australia
Country
Australia
Secondary sponsor category [1] 257252 0
Charities/Societies/Foundations
Name [1] 257252 0
Black Dog Institute
Address [1] 257252 0
Hospital Road,
Prince of Wales Hospital
Randwick NSW 2031, Australia
Country [1] 257252 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260058 0
University of New South Wales - Human Research Ethics Committee
Ethics committee address [1] 260058 0
Ethics committee country [1] 260058 0
Australia
Date submitted for ethics approval [1] 260058 0
Approval date [1] 260058 0
01/10/2010
Ethics approval number [1] 260058 0
HREC10259

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

Contacts
Principal investigator
Name 31915 0
Address 31915 0
Country 31915 0
Phone 31915 0
Fax 31915 0
Email 31915 0
Contact person for public queries
Name 15162 0
Kristy Delmas
Address 15162 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 15162 0
Australia
Phone 15162 0
+612 9382 3769
Fax 15162 0
Email 15162 0
[email protected]
Contact person for scientific queries
Name 6090 0
Vijaya Manicavasagar
Address 6090 0
Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 6090 0
Australia
Phone 6090 0
+612 9382 4320
Fax 6090 0
Email 6090 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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