- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02106078
Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)
2/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Palo Alto, California, United States, 94304
- VA Palo Alto Healthcare System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Level 1
Moderated discussion board only
|
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:
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ACTIVE_COMPARATOR: Level 2
Moderated discussion board plus psychoeducation
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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:
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:
Other Names:
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ACTIVE_COMPARATOR: Level 3
Moderated discussion board plus psychoeducation plus interactive psychosocial tools
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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:
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:
Other Names:
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Change from Baseline to 3 months, 6 months, 9 months and 12 months
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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.
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Change from Baseline to 3 months, 6 months, 9 months and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Changes from Baseline to 3 months, 6 months, 9 months and 12 months
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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)
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Change from Baseline to 3 months, 6 months, 9 months and 12 months
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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).
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Change from Baseline to 3 months, 6 months, 9 months and 12 months
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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
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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.
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Change from baseline to 3 months, 6 months, 9 months and 12 months
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Medication Adherence rating Scale( MARS)
Time Frame: Changes from Baseline to 3 months, 6months, 9 months and 12 months
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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.
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Changes from Baseline to 3 months, 6months, 9 months and 12 months
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Patient satisfaction Questionnaire 18( PSQ-18)
Time Frame: Changes from Baseline to 3 months, 6 months, 9 months and 12 months
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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.
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Changes from Baseline to 3 months, 6 months, 9 months and 12 months
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Treatment Satisfaction Questionnaire- Modified
Time Frame: Changes from Baseline to 3 months, 6 months, 9 months and 12 months
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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
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Changes from Baseline to 3 months, 6 months, 9 months and 12 months
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Medical Outcomes Study Social Support Survey( MOS-SSS)
Time Frame: Changes from Baseline to 3 months, 6 months, 9 months and 12 months
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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.
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Changes from Baseline to 3 months, 6 months, 9 months and 12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Changes from Baseline to 3 months, 6 months, 9 months and 12 months
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Motivation for Treatment Questionnaire - 8 item ( MTQ 8)
Time Frame: Changes from Baseline to 3 months, 6 months,9months and 12 months
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The motivation for Treatment Questionnaire( MTQ-8) consists of eight questions to assess motivational reasons to seek treatment.
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Changes from Baseline to 3 months, 6 months,9months and 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Patricia Suppes, MD, PhD, VA Palo Alto Health Care System & Stanford University School of Medicine
Publications and helpful links
General Publications
- Gliddon E, Cosgrove V, Berk L, Lauder S, Mohebbi M, Grimm D, Dodd S, Coulson C, Raju K, Suppes T, Berk M. A randomized controlled trial of MoodSwings 2.0: An internet-based self-management program for bipolar disorder. Bipolar Disord. 2019 Feb;21(1):28-39. doi: 10.1111/bdi.12669. Epub 2018 Jun 21.
- Gliddon E, Lauder S, Berk L, Cosgrove V, Grimm D, Dodd S, Suppes T, Berk M. Evaluating discussion board engagement in the MoodSwings online self-help program for bipolar disorder: protocol for an observational prospective cohort study. BMC Psychiatry. 2015 Oct 14;15:243. doi: 10.1186/s12888-015-0630-7.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R34MH091284 (NIH)
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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