Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000492358
Ethics application status
Approved
Date submitted
8/08/2008
Date registered
30/09/2008
Date last updated
30/09/2008
Type of registration
Retrospectively registered

Titles & IDs
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
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.
Universal Trial Number (UTN)
Trial acronym
Web study for bipolar disorder
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar disorder 3526 0
Condition category
Condition code
Mental Health 3678 3678 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 3242 0
Other interventions
Comparator / control treatment
An ‘attention placebo’ program ‘Virtual Highway for Bipolar Disorder’ was developed as the online control program. It has the same ‘look and feel’ as the active study program, requires participants to complete the same battery of questionaries to monitor mood and functioning but does not provide feedback. Participants are directed towards ‘websites of the week’ which contains specific information on healthy lifestyle e.g. health diet and exercise. On completion of their 12 month program all control group participants are eligible to be enrolled into the study program
Control group
Placebo

Outcomes
Primary outcome [1] 4586 0
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.
Timepoint [1] 4586 0
Survival analysis on phase I data will be done at the completion of Phase 1, which will be 12 months after enrolment of the last parctipant. Data analysis which will be a comparison of Study Group participants finishing Phase I and entering Phase II will be done after 24 months.
Primary outcome [2] 4587 0
Impact of both programs on the level of functioning as measured by Sheehan Disability Scale
Timepoint [2] 4587 0
Further analysis of the impact of the study program will be performed at end of Phase I, 12months into the study.
Secondary outcome [1] 7748 0
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.
Timepoint [1] 7748 0
Data on medication compliance is entered by each parctipant at the start of each session as part of their online "Medication Diary". This asks the parctipant each time they access their program whether or not they have been taking medication as prescribed and if they answer 'no' then requires them to choose form a drop down list a reason that have they changed or ceased medication. Data from this survey will be compared between both groups at the end of Phase I, 12 months.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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)
Allocation to intervention is randomised controlled trial. Allocation was concealed as this was done via a central randomised method using a computer working on a time stamp/series method of randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This was automatically done, using a computer program that utilised time sequencing and the allocation of odd and even numbers to participants.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Partial cross-over design as those in control will go on to complete study program , however, those in study program move into a ‘monitoring only’ program which does not replicate control program. Participants blinded up until completion of first set of questionnaires in the first session of their program. After that point programs branded differently so clearly able to see which program they have been randomised into. Researchers not blinded as although all users de-identified easy to recognise which program user in by ID number.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3709 0
Government body
Name [1] 3709 0
National Health and Medical Research Concil (NHMRC)
Country [1] 3709 0
Australia
Primary sponsor type
Individual
Name
School of Psychiatry, University of New South Wales. Doctorate supervsior Professor Philip Mitchell MB BS (Syd), MD (UNSW), FRANZCP, FRCPsych
Address
Professor and Head of School of Psychiatry
University of New South Wales
Black Dog Institute Buliding
Hospital Road
Randwick
Sydney
2031
Country
Australia
Secondary sponsor category [1] 3326 0
Individual
Name [1] 3326 0
Kay Wilhelm AM, MB BS, MD, FRANZCP
Address [1] 3326 0
Conjoint Professor, School of Psychiatry, Faculty of Medicine, UNSW
Senior Staff Specialist, Consultation Liaison Psychiatry,
Level 4, DeLacy Building, St Vincent's Hospital,
Victoria Street, Sydney, NSW, 2010, AUSTRALIA.
Country [1] 3326 0
Australia
Other collaborator category [1] 364 0
Commercial sector/Industry
Name [1] 364 0
Sentiens Pty Ltd
Address [1] 364 0
36 Parliament Place
West Perth , WA 6008
PO Box 842, West Perth 6872
Country [1] 364 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5762 0
HREC University of New South Wales
Ethics committee address [1] 5762 0
University of New South Wales
Randwick
Sydney, 2052
Ethics committee country [1] 5762 0
Australia
Date submitted for ethics approval [1] 5762 0
Approval date [1] 5762 0
16/05/2005
Ethics approval number [1] 5762 0
04285.

Summary
Brief summary
Bipolar disorder is a chronic relapsing remitting illness which affects 1-2% of the general population. It is rated as being the 6th highest cause of disability world wide (WHO figures) despite recent advances in psychopharmacotherapy. The recognition for a more holistic approach to treatment has emerged with studies showing the positive benefits of a number of psychological interventions including individual and group psychoeducation, cognitive behavioural therapy and family therapy. However, despite recognition of their importance, as seen by their inclusion in the recent RANZCP treatment guidelines for bipolar disorder, they are not part of standardised clinical practice within local mental health services for many reasons. The Internet is now increasingly being used to deliver a variety of interventions for people living with a chronic illness. A recent study (BMJ 2003) showed that an web-based cognitive behavioural therapy program (Mood Gym) produced statistically significant reductions in the symptoms of depression in its users. The purpose of this study is to determine if programs designed for and delivered over the internet can help people with bipolar disorder stay well. Specifically if such programs can help reduce symptoms, reduce rates of relapse and admissions into hospital and assist people to remain on medication. This study is a randomised controlled trial, which means that if found to be suitable for inclusion into the study, all participants will be randomly assigned to one of two treatment groups, either ‘Bipolar Disorder Recovery Road’ or 'The Virtual Highway for Bipolar Disorder’.
The ‘Bipolar Disorder Recovery Road’ program consists of twenty sessions and will be presented over a 12-month period. It will allow participants access to the following Internet-based features:
• personal medical record including a medications record.
• questionnaires that monitor progress and provide feedback via graphs
• an online diary
• specific educational material on bipolar disorder and its treatment, presented on a session by session basis; With information delivered under sections entitled ‘Dealing with Symptoms’, ‘Managing Side Effects’, ‘Medication Issues’ , ‘Psychological Issues’ and ‘Staying Safe’.
• further educational material referred to as ‘suggested readings’ provides further more detailed information to assist in making treatment decisions.
• 12 sessions of Cognitive Behavioural Therapy (CBT) designed to help identify early warning signs and to manage symptoms.
• Regular email reminders to take medication and to logon into the program.
• Access to 'Website of the week'

The 'Bipolar Disorder Virtual Highway’ program will run over same time frame and will allow participants access to the following Internet-based features :
• Personal medical record including a medications record.
• Questionnaires that monitor progress
• Online diary
• ‘Website Virtual Tour’ feature which provides links to quality assessed websites offering variety of information about healthy lifestyles and ways to stay well.
On completion of the Virtual Highway Program for Bipolar Disorder, all participants will be eligible to be enrolled into the 'Bipolar Disorder Recovery Road' program for a further 12 months ( free of charge).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28822 0
Address 28822 0
Country 28822 0
Phone 28822 0
Fax 28822 0
Email 28822 0
Contact person for public queries
Name 11979 0
Dr Caryl Barnes
Address 11979 0
c/o Professor Philip Mitchell
School of Psychiatry
University of New South Wales
Black Dog Institute Buliding
Hospital Road
Randwick
Sydney
2031
Country 11979 0
Australia
Phone 11979 0
+61-2-93823711
Fax 11979 0
+61-2-93828151
Email 11979 0
c.barnes@unsw.edu.au
Contact person for scientific queries
Name 2907 0
Dr Caryl Barnes
Address 2907 0
c/o Professor Philip Mitchell
School of Psychiatry
University of New South Wales
Black Dog Institute Buliding
Hospital Road
Randwick
Sydney
2031
Country 2907 0
Australia
Phone 2907 0
+61-2-93823711
Fax 2907 0
+61-2-93828151
Email 2907 0
c.barnes@unsw.edu.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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.