Clinical trial NCT02106078: Internet-Based Interventions for Bipolar Disorder
Official title: 2/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
Bipolar
Online Intervention
Internet intervention
Self-Help
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
Collaborators: name: University of Melbourne
First posted: 2014-04-07
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.
* 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.

Primary outcomes:
measure: Montgomery Asberg Rating Scale (MADRS) for Depression
timeFrame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
measure: Young Mania Rating Scale
timeFrame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Secondary outcomes:
measure: Time to Intervention for Mood Episode( TIME)
timeFrame: Changes from Baseline to 3 months, 6 months, 9 months and 12 months
measure: SF-12
timeFrame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
measure: Cornell Service Index (CSI)
timeFrame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
measure: Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
timeFrame: Change from baseline to 3 months, 6 months, 9 months and 12 months
measure: Medication Adherence rating Scale( MARS)
timeFrame: Changes from Baseline to 3 months, 6months, 9 months and 12 months
measure: Patient satisfaction Questionnaire 18( PSQ-18)
timeFrame: Changes from Baseline to 3 months, 6 months, 9 months and 12 months
measure: Treatment Satisfaction Questionnaire- Modified
timeFrame: Changes from Baseline to 3 months, 6 months, 9 months and 12 months
measure: Medical Outcomes Study Social Support Survey( MOS-SSS)
timeFrame: Changes from Baseline to 3 months, 6 months, 9 months and 12 months
Other outcomes:
measure: Inventory Of Stigma Experiences
timeFrame: Changes from Baseline to 3 months, 6 months, 9 months and 12 months
measure: Motivation for Treatment Questionnaire - 8 item ( MTQ 8)
timeFrame: Changes from Baseline to 3 months, 6 months,9months and 12 months
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Healthcare System
state: California
Study officials:
affiliation: VA Palo Alto Health Care System & Stanford University School of Medicine
name: Patricia Suppes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gliddon E, Cosgrove V, Berk L, Lauder S, Mohebbi M, Grimm D, Dodd S, Coulson C, Raju K, Suppes T, Berk M. A randomized controlled trial of MoodSwings 2.0: An internet-based self-management program for bipolar disorder. Bipolar Disord. 2019 Feb;21(1):28-39. doi: 10.1111/bdi.12669. Epub 2018 Jun 21.
citation: Gliddon E, Lauder S, Berk L, Cosgrove V, Grimm D, Dodd S, Suppes T, Berk M. Evaluating discussion board engagement in the MoodSwings online self-help program for bipolar disorder: protocol for an observational prospective cohort study. BMC Psychiatry. 2015 Oct 14;15:243. doi: 10.1186/s12888-015-0630-7.