Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001151224
Ethics application status
Approved
Date submitted
4/07/2018
Date registered
12/07/2018
Date last updated
12/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing a well-being group program to prevent relapse for individuals with mood disorders
Scientific title
Promoting wellbeing and preventing relapse for individuals with mood disorders: A pilot trial of the updated REACH program
Secondary ID [1] 295321 0
Nil
Universal Trial Number (UTN)
U1111-1216-7137
Trial acronym
REACH (Responsibility, Education, Acceptance, Connection, Hope)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bipolar disorder 308678 0
depression 308765 0
Condition category
Condition code
Mental Health 307609 307609 0 0
Depression
Mental Health 307698 307698 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The updated REACH program is a group program designed for individuals with mood disorders (bipolar disorder, depression) who have finished psychological therapy, and would like to take part in a program that provides information and teaches pragmatic skills for maintaining well-being, managing stress, and preventing relapse. The program is based on the principles of responsibility, education, acceptance, connection and hope. The content of the program draws from research in mood disorders and positive psychology and is delivered in a way that is engaging and personal. A psychologist or clinical psychologist with experience in facilitating groups will present the updated REACH program in a group setting (e.g., group of 10 individuals) at the Black Dog Institute. One module of the program is covered in a 2-hour session each week (9 modules in total completed over 9 weeks). Each module includes information, activities, and group discussion about specific topics. Topics covered in the program include: mindfulness, goal setting, risk factors for mood disorders, triggers for relapse, strengths and weaknesses, evoking positive emotions, mood monitoring, expressive writing, stress, coping with stress, challenging unhelpful thoughts, behavioural responses to triggers, identifying a support network, communication and conflict resolution, caring for the carer, problem solving, learning about medications, and communication with a GP or psychiatrist. Adherence will be assessed by the group facilitator in terms of session attendance.
Intervention code [1] 301736 0
Prevention
Intervention code [2] 301737 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306590 0
Characteristics of major depressive episodes, and/or manic/hypomanic episodes in the previous 6 months: number of episodes, measured via a clinical interview
Timepoint [1] 306590 0
Baseline, 6-month follow-up
Primary outcome [2] 306686 0
Characteristics of major depressive episodes, and/or manic/hypomanic episodes in the previous 6 months: duration of episodes, measured via a clinical interview
Timepoint [2] 306686 0
Baseline, 6-month follow-up
Primary outcome [3] 306687 0
Characteristics of major depressive episodes, and/or manic/hypomanic episodes in the previous 6 months: severity of episodes and associated distress, measured via 9-point Likert scales developed for this study
Timepoint [3] 306687 0
Baseline, 6-month follow-up
Secondary outcome [1] 348966 0
manic and depressive symptoms, measured with the Internal State Scale
Timepoint [1] 348966 0
Baseline, 9-weeks post-intervention commencement, 6-month follow-up
Secondary outcome [2] 348967 0
Quality of life, measured with the Satisfaction with Life scale
Timepoint [2] 348967 0
Baseline, 9-weeks post-intervention commencement, 6-month follow-up
Secondary outcome [3] 348968 0
Disability, measured with the World Health Organisation Disability Assessment Schedule 2.0
Timepoint [3] 348968 0
Baseline, 9-weeks post-intervention commencement, 6-month follow-up
Secondary outcome [4] 348969 0
Resilience, measured with the Brief Resilience Scale
Timepoint [4] 348969 0
Baseline, 9-weeks post-intervention commencement, 6-month follow-up
Secondary outcome [5] 348970 0
Optimism, measured with the Life Orientation Test-Revised
Timepoint [5] 348970 0
Baseline, 9-weeks post-intervention commencement, 6-month follow-up
Secondary outcome [6] 348971 0
Social functioning, measured with the Social Adaptation Self-evaluation Scale
Timepoint [6] 348971 0
Baseline, 9-weeks post-intervention commencement, 6-month follow-up
Secondary outcome [7] 348972 0
Coping, measured with the Brief COPE
Timepoint [7] 348972 0
Baseline, 9-weeks post-intervention commencement, 6-month follow-up
Secondary outcome [8] 348973 0
Recovery, measured with the Bipolar Recovery Questionnaire
Timepoint [8] 348973 0
Baseline, 9-weeks post-intervention commencement, 6-month follow-up
Secondary outcome [9] 348974 0
Rumination, measured with the Repetitive Thinking Questionnaire-10
Timepoint [9] 348974 0
Baseline, 9-weeks post-intervention commencement, 6-month follow-up
Secondary outcome [10] 349001 0
Satisfaction with program, measured with the Client Satisfaction Questionnaire
Timepoint [10] 349001 0
9-weeks post-intervention commencement

Eligibility
Key inclusion criteria
1) meeting Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5; American Psychiatric Association, 2013) criteria for depressive disorder or bipolar disorder either in full or partial remission from the most recent affective episode.
2) Diagnosis received at least one year prior to group start date.
3) 18 years of age or older.
4) Capacity to participate in a group setting.
5) Availability to attend the 9 weekly sessions.
6) Referral from clinician/GP indicating suitability for group (e.g., individual accepts illness, individual has motivation to implement personal change strategies).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) very severe mood disturbance or suicidality where urgent intervention is required.
2) current psychosis.
3) severe substance use.
4) unable to engage with materials for physical, practical, or other reasons (e.g., very disabling physical problem, unable to comprehend materials)
5) formal concurrent psychotherapy.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/05/2018
Date of last participant enrolment
Anticipated
31/07/2018
Actual
Date of last data collection
Anticipated
28/02/2019
Actual
Sample size
Target
15
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299910 0
Other
Name [1] 299910 0
Black Dog Institute
Country [1] 299910 0
Australia
Primary sponsor type
Individual
Name
Quincy Wong
Address
Black Dog Institute
University of New South Wales
Hospital Road
Randwick, NSW, 2031
Country
Australia
Secondary sponsor category [1] 299412 0
None
Name [1] 299412 0
Address [1] 299412 0
Country [1] 299412 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300779 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 300779 0
University of New South Wales,
Sydney, NSW, 2052
Ethics committee country [1] 300779 0
Australia
Date submitted for ethics approval [1] 300779 0
15/11/2017
Approval date [1] 300779 0
02/03/2018
Ethics approval number [1] 300779 0
HC17989

Summary
Brief summary
The updated REACH program is designed for individuals with a mood disorder (bipolar disorder, depression) who have finished psychological therapy. The updated REACH program provides information and teaches pragmatic skills to help maintain well-being, manage stress, and prevent relapse. The aim of this project is to test whether: (a) the study procedures used to evaluate the updated REACH program are feasible, and (b) the updated REACH program is acceptable to users. Feasibility of the study procedures will be examined in terms of the participant recruitment rate, and the satisfactory completion of questionnaires and interviews at all assessment time-points by participants (pre-intervention, 9-week post-intervention commencement, and 6-month follow-up). Acceptability of the program will be examined in terms of participant satisfaction with the program. The project will also allow a preliminary examination of the impact of the updated REACH program on well-being, coping, and relapse. It is anticipated that the study procedures of this project will demonstrate feasibility, and the updated REACH program will have high acceptability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84794 0
Dr Quincy Wong
Address 84794 0
Black Dog Institute
University of New South Wales
Hospital Road, Randwick, NSW, 2031
Country 84794 0
Australia
Phone 84794 0
+61 2 93829285
Fax 84794 0
Email 84794 0
quincy.wong@blackdog.org.au
Contact person for public queries
Name 84795 0
Dr Quincy Wong
Address 84795 0
Black Dog Institute
University of New South Wales
Hospital Road, Randwick, NSW, 2031
Country 84795 0
Australia
Phone 84795 0
+61 2 93829285
Fax 84795 0
Email 84795 0
quincy.wong@blackdog.org.au
Contact person for scientific queries
Name 84796 0
Dr Quincy Wong
Address 84796 0
Black Dog Institute
University of New South Wales
Hospital Road, Randwick, NSW, 2031
Country 84796 0
Australia
Phone 84796 0
+61 2 93829285
Fax 84796 0
Email 84796 0
quincy.wong@blackdog.org.au

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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