'Taking control of Bipolar Disorder: staying well, learning more': a 12 month Randomised controlled trial evaluating an online relapse prevention program for bipolar disorder

• Register: ANZCTR
• Last refreshed on: 22 February 2013
• Main ID: ACTRN12608000492358
• Date of registration: 30/09/2008
• Primary sponsor: Individual School of Psychiatry, University of New South Wales. Doctorate supervsior Professor Philip Mitchell MB BS (Syd), MD (UNSW), FRANZCP, FRCPsych
• Public title: 'Taking control of Bipolar Disorder: staying well, learning more': a 12 month Randomised controlled trial evaluating an online relapse prevention program for bipolar disorder Web study for bipolar disorder
• Scientific title: Randomised controlled trial of an online adjunctive program for people with bipolar disorder to see if effective in reducing rates of relapse during phase I , 12 month exposure to the study and phase II during 12 month follow up period.
• Date of first enrolment: 1/07/2006
• Target sample size: 240
• Recruitment status: Closed: follow-up continuing
• URL: http://www.anzctr.org.au/ACTRN12608000492358.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Other

Countries of recruitment

Australia

Contacts

• Name: Dr Caryl Barnes

• Name: Dr Caryl Barnes

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria
Over 18 years of age
Meets criteria for bipolar disorder as confirmed by completion of screening questionnaire
To have a diagnosis of bipolar disorder (diagnosis has to have been made by a mental health professional)
Currently under care of psychiatrist or general practitioner
Taking medication for bipolar disorder.
Has access to internet and printer- at home/ work.
Has an email account/ has email address.
Able to understand written English
Interested in using web based program
Exclusion criteria: Exclusion criteria
Under 18 years of age
Diagnosis of bipolar disorder not supported by results of study screening questionnaire
Not currently under the care of a psychiatrist or general practitioner.
Not on medication for bipolar disorder.

Age minimum: 18 Years
Age maximum: 0 No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Bipolar disorder

Intervention(s)

Study program ‘Recovery road for Bipolar Disorder’ is an online program, accessed through a secure server and website that delivers 'sessions' that combine mood monitoring with psycho-educational material around a variety of topics including; signs and symptoms of bipolar disorder, dealing with medication and managing medication side effects, psychological issues and dealing with relationships and Staying safe. It includes 10 sessions of Cognitive behavioural therapy that focuses on learning to recognise early warning signs of relapse and using these approaches to stay well. A battery of online questionnaires is completed at the start of each session by both study and control parctipant and this makes up the ‘mood monitoring’ section of the programs (includes Beck Depression Inventory, Internal State Scale and Sheehan Disability scales). Only participants in the study program ‘Recovery Road’ receive feedback on their scores and progress, however, from these surveys. Each session is scheduled at fixed intervals over the 12 month study period with a 'window' of 5 days for a participant to access that session. This is the 'session duration' however after this cloases although they can no longer access the mood monitoring/survey section partcipants can still access the content for each current and past sessions through out the 12 month period. Email reminders will be sent during this time to reminding participants to go online, if at the end of the 5 day 'window' this hasn't occurred , a phone call reminder will be made by a research officer to that parctipant. After this time the mood monitoring section is closed. New sessions are scheduled weekly for the first 8 weeks, then fortnightly for a further 4 weeks and then monthly for the remainder of the study period which is in total 12 months. Study participants can track mood swings via feedback from some scales both in report form and graphically. Other features include ability to keep and online journal, an online personal medical record and an 'Appointment Diary' which records contact with mental health services. At the end of the 12 month period participants can choose to either finish their involvement in the study or can consent to enrol into Phase II of the study which is a monitoring only program. This will run for a further 12 months. It will involve mood monitoring via the same set of questionnaires but at 3, 6, 9 and 12 month time intervals. Those randomised into the control program, if they complete the full 12 months will be eligible to enrol into study program which will then run for a further 12 months with data taken at same time intervals

Primary Outcome(s)

Impact of both programs on the level of functioning as measured by Sheehan Disability Scale

Survival analysis, from start of program time to relapse as defined by scores on Beck depression Inventory, using cut offs defined in paper version. Survival analysis, time to relapse as defined by mood state discriminator function of the Internal State Scale.

Survival analysis, time to relapse as defined by self report of admission into hospital.

Secondary Outcome(s)

Compliance with medication as seen by entries into the 'Medication diary' section of the program. Comparisons will be possible with side effect burden due to the completion of a General Symptom Scale which records presence and severity of variety of side effects that can occur with frequently used bipolar medications.

Source(s) of Monetary Support

National Health and Medical Research Concil (NHMRC)

Secondary Sponsor(s)

Kay Wilhelm AM, MB BS, MD, FRANZCP