Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)

University of Melbourne

Status: Completed

Conditions: Bipolar Disorder

Treatments: Behavioral: Interactive Psychosocial Tools; Behavioral: Moderated discussion board; Behavioral: Psychoeducation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02118623

1R34MH091384

Details and patient eligibility

About

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.

Full 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.

Enrollment: 304 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 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

304 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: Moderated discussion board

Behavioral: Psychoeducation

Level 3

Active Comparator group

Description:

Moderated discussion board plus psychoeducation plus interactive psychosocial tools.

Treatment:

Behavioral: Moderated discussion board

Behavioral: Psychoeducation

Behavioral: Interactive Psychosocial Tools