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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
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Scientific title
A Randomised Controlled Trial of a Wellbeing Group Program Versus Treatment as Usual for Adults Recently Diagnosed with Bipolar II Disorder
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Secondary ID [1]
253090
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N/A
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Universal Trial Number (UTN)
U1111-1118-1490
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bipolar disorder
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Condition category
Condition code
Mental Health
258789
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
257608
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Lifestyle
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Intervention code [2]
257609
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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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.
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Secondary outcome [1]
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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.
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Assessment method [1]
266342
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Timepoint [1]
266342
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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.
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Secondary outcome [2]
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Secondary Outcome: Medication adherence
Sceondary Outcome Measure: Medication Adherence Items (Developed for this study) - measures medication adherence and reasons for noncompliance.
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Assessment method [2]
266343
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Timepoint [2]
266343
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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.
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Secondary outcome [3]
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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.
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Assessment method [3]
266344
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Timepoint [3]
266344
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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.
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Secondary outcome [4]
266345
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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.
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Assessment method [4]
266345
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Timepoint [4]
266345
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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.
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Secondary outcome [5]
266346
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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.
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Assessment method [5]
266346
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Timepoint [5]
266346
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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.
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Secondary outcome [6]
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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.
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Assessment method [6]
266371
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Timepoint [6]
266371
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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.
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Secondary outcome [7]
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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.
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Assessment method [7]
266372
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Timepoint [7]
266372
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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.
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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.
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Minimum age
20
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
1/05/2011
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
160
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Department of Health and Ageing
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Address [1]
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GPO Box 9848,
Canberra ACT 2601, Australia
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Country [1]
258060
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Australia
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Primary sponsor type
University
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Name
University of New South Wales
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Address
School of Psychiatry and Black Dog Institute
Hospital Road,
Prince of Wales Hospital
Randwick NSW 2031, Australia
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Country
Australia
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Secondary sponsor category [1]
257252
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Charities/Societies/Foundations
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Name [1]
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Black Dog Institute
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Address [1]
257252
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Hospital Road,
Prince of Wales Hospital
Randwick NSW 2031, Australia
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Country [1]
257252
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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University of New South Wales - Human Research Ethics Committee
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Ethics committee address [1]
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Ethics Secretariat, UNSW Research Services
Rupert Myers Building, Level 3
The University of New South Wales NSW 2052
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Ethics committee country [1]
260058
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Australia
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Date submitted for ethics approval [1]
260058
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Approval date [1]
260058
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01/10/2010
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Ethics approval number [1]
260058
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HREC10259
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Summary
Brief summary
Research in bipolar disorder has suggested that recovery from the illness consists of a three-pronged approach involving medication, information/education about the disorder, and having a plan or strategy to remain well. The current study combines the latter two psychosocial approaches to recovery in bipolar disorder into one intervention. It aims to examine the efficacy of an 8-session group psychoeducation program for adults recently diagnosed with bipolar II disorder that incorporates the development of an individualised comprehensive wellbeing plan across sessions.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
31915
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Fax
31915
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Email
31915
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Contact person for public queries
Name
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Kristy Delmas
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Address
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Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
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Country
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Australia
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Phone
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+612 9382 3769
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Vijaya Manicavasagar
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Address
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Black Dog Institute
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
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Country
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Australia
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Phone
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+612 9382 4320
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Fax
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Email
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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