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Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)

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ClinicalTrials.gov Identifier: NCT02106078
Recruitment Status : Unknown
Verified September 2015 by patricia suppes, VA Palo Alto Health Care System.
Recruitment status was:  Active, not recruiting
First Posted : April 7, 2014
Last Update Posted : September 10, 2015
Sponsor:
Collaborator:
University of Melbourne
Information provided by (Responsible Party):
patricia suppes, VA Palo Alto Health Care System

Brief Summary:
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.

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 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 2/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder
Study Start Date : January 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 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 (Mead et al., 2010).

The discussion boards will be moderated by trained clinicians (masters level 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 (Mead et al., 2010).

The discussion boards will be moderated by trained clinicians (masters level 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 (Mead et al., 2010).

The discussion boards will be moderated by trained clinicians (masters level 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 behaviors, 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 Rating Scale (MADRS) for Depression [ 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 [ 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: Changes from Baseline to 3 months, 6 months, 9 months and 12 months ]
    Relapse or time to intervention will be assessed using 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 as due to emotional problems (Ware et al., 1996)

  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; Sirey et al., 2005). 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 and social relationships). The 16 item short form is designated to measure satisfaction with various areas of daily functioning, such as social relationships, living/housing, physical heath, medication and global satisfaction.

  5. Medication Adherence rating Scale( MARS) [ Time Frame: Changes from Baseline to 3 months, 6months, 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.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: Changes from Baseline to 3 months, 6 months, 9 months and 12 months ]
    The Patient satisfaction Questionnaire 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 PSQIII subscales are substantially correlated with one another.

  7. Treatment Satisfaction Questionnaire- Modified [ Time Frame: Changes 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 the 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: Changes 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: Changes 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: Changes from Baseline to 3 months, 6 months,9months 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 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.

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): NCT02106078


Locations
United States, California
VA Palo Alto Healthcare System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
VA Palo Alto Health Care System
University of Melbourne
Investigators
Principal Investigator: Patricia Suppes, MD, PhD VA Palo Alto Health Care System & Stanford University School of Medicine

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: patricia suppes, Director, Bipolar and Depression Research Program, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT02106078     History of Changes
Other Study ID Numbers: 1R34MH091284 ( U.S. NIH Grant/Contract )
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: September 10, 2015
Last Verified: September 2015

Keywords provided by patricia suppes, VA Palo Alto Health Care System:
Bipolar Disorder
Bipolar
Online Intervention
Internet intervention
Self-Help

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