Overview

This trial is active, not recruiting.

Condition bipolar disorder
Treatments moderated discussion board, psychoeducation, interactive psychosocial tools
Sponsor VA Palo Alto Health Care System
Collaborator University of Melbourne
Start date January 2014
End date December 2015
Trial size 300 participants
Trial identifier NCT02106078, 1R34MH091284

Summary

The investigators hope to learn whether access to online support and education can help people with Bipolar Disorder (BD) better manage their symptoms of depression.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Active Comparator)
Moderated discussion board only
moderated discussion board discussion board
All groups will have access to asynchronous, moderated discussion boards. Assignment to discussion board will be stratified by randomization group (Level 1, 2 or 3). Level 1 access to the discussion board will serve as our "peer support" control condition, although we do expect some modest benefit from this intervention alone (Mead et al., 2010). The discussion boards will be moderated by trained clinicians (masters level or higher). Discussion boards will be asynchronous, with all posts screened by the moderator(s) before appearing to the group.
(Active Comparator)
Moderated discussion board plus psychoeducation
moderated discussion board discussion board
All groups will have access to asynchronous, moderated discussion boards. Assignment to discussion board will be stratified by randomization group (Level 1, 2 or 3). Level 1 access to the discussion board will serve as our "peer support" control condition, although we do expect some modest benefit from this intervention alone (Mead et al., 2010). The discussion boards will be moderated by trained clinicians (masters level or higher). Discussion boards will be asynchronous, with all posts screened by the moderator(s) before appearing to the group.
psychoeducation Online psychoeducation
Online psychoeducation is only available to those randomized to Levels 2 and 3. The core modules of MoodSwings 2.0 will use videos and improved organization of content based on feedback from previous pilot work. Module topic areas include: What is bipolar disorder? - Content about symptoms and diagnosis Stress and triggers of illness Medication and the biological basis of bipolar disorder Depression - Symptoms, early detection and helpful strategies Mania and hypomania - Symptoms, early detection and helpful strategies
(Active Comparator)
Moderated discussion board plus psychoeducation plus interactive psychosocial tools
moderated discussion board discussion board
All groups will have access to asynchronous, moderated discussion boards. Assignment to discussion board will be stratified by randomization group (Level 1, 2 or 3). Level 1 access to the discussion board will serve as our "peer support" control condition, although we do expect some modest benefit from this intervention alone (Mead et al., 2010). The discussion boards will be moderated by trained clinicians (masters level or higher). Discussion boards will be asynchronous, with all posts screened by the moderator(s) before appearing to the group.
psychoeducation Online psychoeducation
Online psychoeducation is only available to those randomized to Levels 2 and 3. The core modules of MoodSwings 2.0 will use videos and improved organization of content based on feedback from previous pilot work. Module topic areas include: What is bipolar disorder? - Content about symptoms and diagnosis Stress and triggers of illness Medication and the biological basis of bipolar disorder Depression - Symptoms, early detection and helpful strategies Mania and hypomania - Symptoms, early detection and helpful strategies
interactive psychosocial tools Interactive tools
Online psychosocial tools are only available to those randomized to Level 3. They include structured mood monitoring, medication monitoring, and life charting visual tools. There are also interactive worksheets that encourage awareness of negative thoughts and strategies to challenge them, help participants weight the costs and benefits of different behaviors, problem solving and goal setting, and reinforcing self-affirmation. Participants have the opportunity to build a record of personal triggers of illness and illness profile - including early warning signs, and symptoms typically experienced during an episode of illness, as well as a personal "relapse prevention plan."

Primary Outcomes

Measure
Montgomery Asberg Rating Scale (MADRS) for Depression
time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Young Mania Rating Scale
time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months

Secondary Outcomes

Measure
Time to Intervention for Mood Episode( TIME)
time frame: Changes from Baseline to 3 months, 6 months, 9 months and 12 months
SF-12
time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Cornell Service Index (CSI)
time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
time frame: Change from baseline to 3 months, 6 months, 9 months and 12 months
Medication Adherence rating Scale( MARS)
time frame: Changes from Baseline to 3 months, 6months, 9 months and 12 months
Patient satisfaction Questionnaire 18( PSQ-18)
time frame: Changes from Baseline to 3 months, 6 months, 9 months and 12 months
Treatment Satisfaction Questionnaire- Modified
time frame: Changes from Baseline to 3 months, 6 months, 9 months and 12 months
Medical Outcomes Study Social Support Survey( MOS-SSS)
time frame: Changes from Baseline to 3 months, 6 months, 9 months and 12 months

Eligibility Criteria

Male or female participants from 21 years up to 65 years old.

Inclusion Criteria: - Current diagnosis of bipolar I disorder, bipolar II disorder, or bipolar disorder NOS verified with the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID) Mood disorder module. - Age 21-65. - Access to a computer with internet access. Access to a printer is preferable, but not required. - Able to speak and read English proficiently. - Some degree of medical supervision of bipolar disorder (sees a health professional at least twice a year to discuss symptoms and treatment needs) and local access to emergency care. Exclusion Criteria: - Current psychosis, as assessed in screening phone interview with the SCID psychosis module. - Acutely suicidal (defined as having a HAM-D item 3, score of ≥3). - Current mania, assessed using mania module of the SCID mood disorders module.

Additional Information

Official title 2/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder
Principal investigator Patricia Suppes, MD, PhD
Description This study will examine if there is a benefit of an online intervention for persons with bipolar diagnoses, and what components appear to be useful. Specifically, the study will examine (1) whether exposure to the MoodSwings 2.0 intervention results in decreased depressive symptoms as measured by the Montgomery Asberg Rating Scale for Depression (MADRS) and (2) whether there is an association between graduated levels of involvement (Level I, 2, or 3) and resulting improvement? We expect that those participants assigned to the control condition (Level 1, peer discussion board only), will have fewer positive outcomes than those in Level 2 (discussion board and psychoeducation) or 3 (discussion board, psychoeducation, and interactive psychosocial tools) conditions.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by VA Palo Alto Health Care System.