Clinical trial NCT02118623: Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)
Official title: 1/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
Bipolar
Online intervention
Internet intervention
Self help
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: VA Palo Alto Health Care System
First posted: 2014-04-21
Enrollment: 304
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: This study will examine if there is a benefit of an online intervention for persons with bipolar diagnoses, and what components appear to be most useful.

Detailed description: This study will examine whether exposure to the three different components of the MoodSwings 2.0 intervention results in decreased depressive symptoms as measured by the Montgomery Asberg Depression Rating Scale (MADRS), and decreased manic symptoms as measured by the Young Mania Rating Scale (YMRS). The three components of the MoodSwings 2.0 intervention are:

* Moderated peer discussion board
* Psychoeducation learning modules
* Interactive psychosocial tools

This study will also examine whether there is an association between graduated levels of involvement and resulting improvement. These graduated levels are:

* Moderated peer discussion board only (Level 1)
* Moderated peer discussion board and psychoeducation learning modules (Level 2)
* Moderated peer discussion board, psychoeducation learning modules and interactive psychosocial tools (Level 3).

We expect that those participants assigned to the control condition (Level 1), will have fewer positive outcomes than those in Level 2 or Level 3 conditions.

Eligibility criteria: Inclusion Criteria:

* Current diagnosis of bipolar I disorder, bipolar II disorder, or bipolar disorder not otherwise specified (NOS) verified with the Structured Clinical Interview for the Diagnostic Manual for Mental Disorders (SCID) mood disorders module.
* Age 21 to 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).
* Local access to emergency care.

Exclusion Criteria:

* Current psychosis, as assessed in screening phone interview with the SCID psychotic screening module.
* Acutely suicidal (defined as having a Hamilton Rating Scale for Depression \[HAM-D\] item 3 scores of ≥ 3)
* Current mania, assessed using the SCID mood disorder module.

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
measure: Young Mania Rating Scale (YMRS)
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: Change from 3 months to 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: Change from Baseline to 3 months, 6 months, 9 months and 12 months
measure: Patient Satisfaction Questionnaire 18 (PSQ-18)
timeFrame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
measure: Treatment Satisfaction Questionnaire-Modified
timeFrame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
measure: Medical Outcomes Study Social Support Survey (MOS-SSS)
timeFrame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Other outcomes:
measure: Inventory of Stigma Experiences
timeFrame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
measure: Motivation for Treatment Questionnaire - 8 item (MTQ-8)
timeFrame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Locations:
city: Geelong
country: Australia
facility: University of Melbourne - Barwon Health
state: Victoria
Study officials:
affiliation: Deakin University and University of Melbourne
name: Michael Berk, FFPsych, 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.