Internet-Based Interventions for Bipolar Disorder

Bipolar Disorder Clinical Trial

— MoodSwings 2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02106078
• Other study ID #: 1R34MH091284
• Status: Active, not recruiting
• Phase: N/A
• First received: May 16, 2013
• Last updated: September 8, 2015
• Start date: January 2014
• Est. completion date: June 2016

Study information

• Verified date: September 2015
• Source: VA Palo Alto Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

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.
• 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: 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
• 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."

Locations

Country	Name	City	State
United States	VA Palo Alto Healthcare System	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Palo Alto Health Care System	University of Melbourne

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inventory Of Stigma Experiences	This scale will be used to measure both the self reported experiences of stigma and the impact of stigma	Changes from Baseline to 3 months, 6 months, 9 months and 12 months	No
Other	Motivation for Treatment Questionnaire - 8 item ( MTQ 8)	The motivation for Treatment Questionnaire( MTQ-8) consists of eight questions to assess motivational reasons to seek treatment.	Changes from Baseline to 3 months, 6 months,9months and 12 months	No
Primary	Montgomery Asberg Rating Scale (MADRS) for Depression	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	No
Primary	Young Mania Rating Scale	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	No
Secondary	Time to Intervention for Mood Episode( TIME)	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.	Changes from Baseline to 3 months, 6 months, 9 months and 12 months	Yes
Secondary	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 as due to emotional problems (Ware et al., 1996)	Change from Baseline to 3 months, 6 months, 9 months and 12 months	No
Secondary	Cornell Service Index (CSI)	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).	Change from Baseline to 3 months, 6 months, 9 months and 12 months	No
Secondary	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 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.	Change from baseline to 3 months, 6 months, 9 months and 12 months	No
Secondary	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.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.	Changes from Baseline to 3 months, 6months, 9 months and 12 months	No
Secondary	Patient satisfaction Questionnaire 18( PSQ-18)	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.	Changes from Baseline to 3 months, 6 months, 9 months and 12 months	No
Secondary	Treatment Satisfaction Questionnaire- Modified	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	Changes from Baseline to 3 months, 6 months, 9 months and 12 months	No
Secondary	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.	Changes from Baseline to 3 months, 6 months, 9 months and 12 months	No

External Links

•   MoodSwings Website