2/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bipolar Disorder
- Sponsor
- VA Palo Alto Health Care System
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Montgomery Asberg Rating Scale (MADRS) for Depression
- Last Updated
- 10 years ago
Overview
Brief 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.
Detailed 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.
Investigators
patricia suppes
Director, Bipolar and Depression Research Program
VA Palo Alto Health Care System
Eligibility Criteria
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.
- •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.
Outcomes
Primary Outcomes
Montgomery Asberg Rating Scale (MADRS) for Depression
Time Frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
The MADRS is a 10-item scale, completed by the clinician to assess symptoms of depression. It is particularly sensitive to changes in depression over time. Joint reliability for the total score across several studies ranged from 0.76 to 0.95, and it is viewed as a reliable and valid measure of depression symptoms.
Young Mania Rating Scale
Time Frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
The YMRS is an 11-item scale, completed by the clinician to assess symptoms of mania. This scale is viewed as a reliable and valid measure of manic symptoms, and is sensitive to changes in mania over time.
Secondary Outcomes
- Time to Intervention for Mood Episode( TIME)(Changes from Baseline to 3 months, 6 months, 9 months and 12 months)
- SF-12(Change from Baseline to 3 months, 6 months, 9 months and 12 months)
- Cornell Service Index (CSI)(Change from Baseline to 3 months, 6 months, 9 months and 12 months)
- Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)(Change from baseline to 3 months, 6 months, 9 months and 12 months)
- Medication Adherence rating Scale( MARS)(Changes from Baseline to 3 months, 6months, 9 months and 12 months)
- Patient satisfaction Questionnaire 18( PSQ-18)(Changes from Baseline to 3 months, 6 months, 9 months and 12 months)
- Treatment Satisfaction Questionnaire- Modified(Changes from Baseline to 3 months, 6 months, 9 months and 12 months)
- Medical Outcomes Study Social Support Survey( MOS-SSS)(Changes from Baseline to 3 months, 6 months, 9 months and 12 months)