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Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)

V

VA Palo Alto Health Care System

Status

Unknown

Conditions

Bipolar Disorder

Treatments

Behavioral: Psychoeducation
Behavioral: Moderated Discussion Board
Behavioral: Interactive Psychosocial Tools

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT02106078
1R34MH091284

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

300 participants in 3 patient groups

Level 1
Active Comparator group
Description:
Moderated discussion board only
Treatment:
Behavioral: Moderated Discussion Board
Level 2
Active Comparator group
Description:
Moderated discussion board plus psychoeducation
Treatment:
Behavioral: Psychoeducation
Behavioral: Moderated Discussion Board
Level 3
Active Comparator group
Description:
Moderated discussion board plus psychoeducation plus interactive psychosocial tools
Treatment:
Behavioral: Psychoeducation
Behavioral: Interactive Psychosocial Tools
Behavioral: Moderated Discussion Board

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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