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Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)

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ClinicalTrials.gov Identifier: NCT02118623
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
VA Palo Alto Health Care System
Information provided by (Responsible Party):
Michael Berk, University of Melbourne

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Behavioral: Moderated discussion board Behavioral: Psychoeducation Behavioral: Interactive Psychosocial Tools Not Applicable

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  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 1/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder
Study Start Date : January 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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:
  • Online psychoeducation
  • Online education
  • 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:
  • Online psychoeducation
  • Online education
  • 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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118623


Locations
Australia, Victoria
University of Melbourne - Barwon Health
Geelong, Victoria, Australia, 3220
Sponsors and Collaborators
University of Melbourne
VA Palo Alto Health Care System
Investigators
Principal Investigator: Michael Berk, FFPsych, PhD Deakin University and University of Melbourne

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Berk, Honorary Adjunct Professor, University of Melbourne
ClinicalTrials.gov Identifier: NCT02118623     History of Changes
Other Study ID Numbers: 1R34MH091384 ( U.S. NIH Grant/Contract )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by Michael Berk, University of Melbourne:
Bipolar Disorder
Bipolar
Online intervention
Internet intervention
Self help

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders