Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)

October 24, 2017 updated by: Michael Berk, University of Melbourne

1/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

304

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • University of Melbourne - Barwon Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Level 1
Moderated discussion board only
Behavioral: Moderated discussion board

All groups will have access to asynchronous, moderated discussion boards. Assignment to discussion board will be stratified by randomization group (Level 1, 2 or 3). Level 1 access to the discussion board will serve as our "peer support" control condition, although we do expect some modest benefit from this intervention alone.

The discussion boards will be moderated by research staff, who will be supervised by a trained clinician (masters levels or higher). Discussion boards will be asynchronous, with all posts screened by the moderator(s) before appearing to the group.

Other Names:
  • discussion board
  • online discussion
  • online posts
  • online discussion boards
  • forum
  • discussion forum
  • support group
  • discussion group
Active Comparator: Level 2
Moderated discussion board plus psychoeducation
Behavioral: Moderated discussion board

All groups will have access to asynchronous, moderated discussion boards. Assignment to discussion board will be stratified by randomization group (Level 1, 2 or 3). Level 1 access to the discussion board will serve as our "peer support" control condition, although we do expect some modest benefit from this intervention alone.

The discussion boards will be moderated by research staff, who will be supervised by a trained clinician (masters levels or higher). Discussion boards will be asynchronous, with all posts screened by the moderator(s) before appearing to the group.

Other Names:
  • discussion board
  • online discussion
  • online posts
  • online discussion boards
  • forum
  • discussion forum
  • support group
  • discussion group
Behavioral: Psychoeducation

Online psychoeducation is only available to those randomized to Levels 2 and 3. The core modules of MoodSwings 2.0 will use videos and improved organization of content based on feedback from previous pilot work. Module topic areas include:

  1. What is bipolar disorder? - Content about symptoms and diagnosis
  2. Stress and triggers of illness
  3. Medication and the biological basis of bipolar disorder
  4. Depression - Symptoms, early detection and helpful strategies
  5. Mania and hypomania - Symptoms, early detection and helpful strategies.
Other Names:
  • Education
  • Online psychoeducation
  • Online education
Active Comparator: Level 3
Moderated discussion board plus psychoeducation plus interactive psychosocial tools.
Behavioral: Moderated discussion board

All groups will have access to asynchronous, moderated discussion boards. Assignment to discussion board will be stratified by randomization group (Level 1, 2 or 3). Level 1 access to the discussion board will serve as our "peer support" control condition, although we do expect some modest benefit from this intervention alone.

The discussion boards will be moderated by research staff, who will be supervised by a trained clinician (masters levels or higher). Discussion boards will be asynchronous, with all posts screened by the moderator(s) before appearing to the group.

Other Names:
  • discussion board
  • online discussion
  • online posts
  • online discussion boards
  • forum
  • discussion forum
  • support group
  • discussion group
Behavioral: Psychoeducation

Online psychoeducation is only available to those randomized to Levels 2 and 3. The core modules of MoodSwings 2.0 will use videos and improved organization of content based on feedback from previous pilot work. Module topic areas include:

  1. What is bipolar disorder? - Content about symptoms and diagnosis
  2. Stress and triggers of illness
  3. Medication and the biological basis of bipolar disorder
  4. Depression - Symptoms, early detection and helpful strategies
  5. Mania and hypomania - Symptoms, early detection and helpful strategies.
Other Names:
  • Education
  • Online psychoeducation
  • Online education
Behavioral: Interactive Psychosocial Tools
Online psychosocial tools are only available to those randomized to Level 3. They include structured mood monitoring, medication monitoring, and life charting visual tools. There are also interactive worksheets that encourage awareness of negative thoughts and strategies to challenge them, help participants weight the costs and benefits of different behaviours, problem solving and goal setting, and reinforcing self-affirmation. Participants have the opportunity to build a record of personal triggers of illness and illness profile - including early warning signs, and symptoms typically experienced during an episode of illness, as well as a personal "relapse prevention plan".
Other Names:
  • Interactive tools
  • Online tools
  • Online interactive tools

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)
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.
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Young Mania Rating Scale (YMRS)
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.
Change from Baseline to 3 months, 6 months, 9 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Intervention for Mood Episode (TIME)
Time Frame: Change from 3 months to 6 months, 9 months and 12 months
Relapse or time to invention will be assessed using the TIME scale, with intervention defined as initiation, discontinuation, or dose adjustment of a treatment, initiation of psychotherapy or ECT, visit to an emergency provider or hospitalization in response to new mood symptoms.
Change from 3 months to 6 months, 9 months and 12 months
SF-12
Time Frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
The SF-12 is a short, multipurpose measure of perceived impairment due to health problems. It is widely used as a short version of the SF-36, and has good validity. The SF-12 yields two risk-adjusted summary scores, impairment perceived as due to physical illness, and impairment perceived due to emotional problems.
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Cornell Service Index (CSI)
Time Frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Use of general medical and psychiatric health services will be collected via the Cornell Service Index (CSI). The CSI is a brief assessment of health service use. It has good inter-rater and test-retest reliability and assesses four types of services: outpatient psychiatric or psychological services (e.g. psychotropic medication visits or psychotherapy), outpatient medical services (e.g. visits to medical providers), professional support services (e.g. home health nurse visits, meal delivery), and intensive services (e.g. emergency department visits or hospitalization).
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Time Frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
The Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q) assesses subjective quality of life (i.e. physical health, subjective feelings, leisure activities and social relationships). The 16-item short form is designed to measure satisfaction with various areas of daily functioning, such as social relationships, living/housing, physical health, medication, and global satisfaction.
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Medication Adherence Rating Scale (MARS)
Time Frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
When applicable, adherence to prescribed medication will be assessed with the Medication Adherence Rating Scale (MARS). This 10-item scale has acceptable reliability, with Cronbach's alpha 0.75, and test re-test reliability 0.72. It is seen as a valid measure with significant correlations with other measures of medication adherence (p<.01) and with serum blood levels at p<.05.
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Patient Satisfaction Questionnaire 18 (PSQ-18)
Time Frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
The Patient Satisfaction Questionnaire 18 (PSQ-18) assesses the overall satisfaction of each participant with their current medical care. This 18-item scale is a short form version of the 50-item Patient Satisfaction Questionnaire. The PSQ sub-scales show acceptable internal consistency reliability. Furthermore, corresponding PSQ-18 and PSQ-III subscales are substantially correlated with one another.
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Treatment Satisfaction Questionnaire-Modified
Time Frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
For the purposes of this study, the Treatment Satisfaction Questionnaire-Modified was revised to suit bipolar disorder and the MoodSwings 2.0 program. This questionnaire was originally a modified version of the Treatment Satisfaction Questionnaire.
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Medical Outcomes Study Social Support Survey (MOS-SSS)
Time Frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Social support will be assessed with the Medical Outcomes Study Social Support Survey. This 18-item scale has acceptable reliability (alpha >0.91) and construct validity, and was specifically developed for people with chronic conditions.
Change from Baseline to 3 months, 6 months, 9 months and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inventory of Stigma Experiences
Time Frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
This scale will be used to measure both the self-reported experiences of stigma and the impact of stigma.
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Motivation for Treatment Questionnaire - 8 item (MTQ-8)
Time Frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
The Motivation for Treatment Questionnaire (MTQ-8) consists of eight questions to assess motivational reasons to seek treatment.
Change from Baseline to 3 months, 6 months, 9 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Melbourne

Collaborators

VA Palo Alto Health Care System

Investigators

  • Principal Investigator: Michael Berk, FFPsych, PhD, Deakin University and University of Melbourne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

April 16, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R34MH091384 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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