Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)
- Conditions
- Bipolar Disorder
- Interventions
- Behavioral: Moderated discussion boardBehavioral: PsychoeducationBehavioral: Interactive Psychosocial Tools
- Registration Number
- NCT02118623
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 304
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Level 2 Moderated discussion board Moderated discussion board plus psychoeducation Level 3 Interactive Psychosocial Tools Moderated discussion board plus psychoeducation plus interactive psychosocial tools. Level 1 Moderated discussion board Moderated discussion board only Level 3 Psychoeducation Moderated discussion board plus psychoeducation plus interactive psychosocial tools. Level 2 Psychoeducation Moderated discussion board plus psychoeducation Level 3 Moderated discussion board Moderated discussion board plus psychoeducation plus interactive psychosocial tools.
- Primary Outcome Measures
Name Time Method Montgomery-Asberg Depression Rating Scale (MADRS) 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.
Young Mania Rating Scale (YMRS) 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
Name Time Method Time to Intervention for Mood Episode (TIME) 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.
SF-12 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.
Cornell Service Index (CSI) 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).
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) 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.
Medication Adherence Rating Scale (MARS) 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.
Patient Satisfaction Questionnaire 18 (PSQ-18) 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.
Treatment Satisfaction Questionnaire-Modified 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.
Medical Outcomes Study Social Support Survey (MOS-SSS) 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.
Trial Locations
- Locations (1)
University of Melbourne - Barwon Health
🇦🇺Geelong, Victoria, Australia