None listed
Conditions
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).
Interventions
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
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
Sponsors
School of Psychiatry, University of New South Wales. Doctorate supervsior Professor Philip Mitchell MB BS (Syd), MD (UNSW), FRANZCP, FRCPsych
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed