Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Behavioral: Moderated discussion board
* Behavioral: Psychoeducation
* Behavioral: Interactive Psychosocial Tools


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Level 1<br>Moderated discussion board only | Behavioral: Moderated discussion board<br>* 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.<br>* Other names: discussion group;|
| Active Comparator: Level 2<br>Moderated discussion board plus psychoeducation | Behavioral: Moderated discussion board<br>* 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.<br>* Other names: discussion group;Behavioral: Psychoeducation<br>* 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: What is bipolar disorder? - Content about symptoms and diagnosis Stress and triggers of illness Medication and the biological basis of bipolar disorder Depression - Symptoms, early detection and helpful strategies Mania and hypomania - Symptoms, early detection and helpful strategies.<br>* Other names: Education;|
| Active Comparator: Level 3<br>Moderated discussion board plus psychoeducation plus interactive psychosocial tools. | Behavioral: Moderated discussion board<br>* 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.<br>* Other names: discussion group;Behavioral: Psychoeducation<br>* 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: What is bipolar disorder? - Content about symptoms and diagnosis Stress and triggers of illness Medication and the biological basis of bipolar disorder Depression - Symptoms, early detection and helpful strategies Mania and hypomania - Symptoms, early detection and helpful strategies.<br>* Other names: Education;Behavioral: Interactive Psychosocial Tools<br>* 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.<br>* Other names: Online interactive tools;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale (MADRS) | 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) | 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) | 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 | 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) | 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) | 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) | 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) | 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 | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar Disorder, Bipolar, Online intervention, Internet intervention, Self help