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Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)

Primary Purpose

Bipolar Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moderated Discussion Board
Psychoeducation
Interactive Psychosocial Tools
Sponsored by
VA Palo Alto Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bipolar Disorder focused on measuring Bipolar Disorder, Bipolar, Online Intervention, Internet intervention, Self-Help

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Palo Alto Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Level 1

Level 2

Level 3

Arm Description

Moderated discussion board only

Moderated discussion board plus psychoeducation

Moderated discussion board plus psychoeducation plus interactive psychosocial tools

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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)
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).
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.
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.
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.
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
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.

Full Information

First Posted
May 16, 2013
Last Updated
September 8, 2015
Sponsor
VA Palo Alto Health Care System
Collaborators
University of Melbourne
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1. Study Identification

Unique Protocol Identification Number
NCT02106078
Brief Title
Internet-Based Interventions for Bipolar Disorder
Acronym
MoodSwings 2
Official Title
2/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System
Collaborators
University of Melbourne

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar Disorder, Bipolar, Online Intervention, Internet intervention, Self-Help

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Level 1
Arm Type
Active Comparator
Arm Description
Moderated discussion board only
Arm Title
Level 2
Arm Type
Active Comparator
Arm Description
Moderated discussion board plus psychoeducation
Arm Title
Level 3
Arm Type
Active Comparator
Arm Description
Moderated discussion board plus psychoeducation plus interactive psychosocial tools
Intervention Type
Behavioral
Intervention Name(s)
Moderated Discussion Board
Other Intervention Name(s)
discussion board, online discussion, online posts, online discussion boards, forum, discussion forum, support group, discussion group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Other Intervention Name(s)
Online psychoeducation, Online education, Education
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Interactive Psychosocial Tools
Other Intervention Name(s)
Interactive tools, Online tools, Online interactive tools
Intervention Description
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."
Primary Outcome Measure Information:
Title
Montgomery Asberg Rating Scale (MADRS) for Depression
Description
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.
Time Frame
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Title
Young Mania Rating Scale
Description
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.
Time Frame
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Secondary Outcome Measure Information:
Title
Time to Intervention for Mood Episode( TIME)
Description
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.
Time Frame
Changes from Baseline to 3 months, 6 months, 9 months and 12 months
Title
SF-12
Description
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)
Time Frame
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Title
Cornell Service Index (CSI)
Description
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).
Time Frame
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Title
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Description
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.
Time Frame
Change from baseline to 3 months, 6 months, 9 months and 12 months
Title
Medication Adherence rating Scale( MARS)
Description
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.
Time Frame
Changes from Baseline to 3 months, 6months, 9 months and 12 months
Title
Patient satisfaction Questionnaire 18( PSQ-18)
Description
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.
Time Frame
Changes from Baseline to 3 months, 6 months, 9 months and 12 months
Title
Treatment Satisfaction Questionnaire- Modified
Description
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
Time Frame
Changes from Baseline to 3 months, 6 months, 9 months and 12 months
Title
Medical Outcomes Study Social Support Survey( MOS-SSS)
Description
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.
Time Frame
Changes from Baseline to 3 months, 6 months, 9 months and 12 months
Other Pre-specified Outcome Measures:
Title
Inventory Of Stigma Experiences
Description
This scale will be used to measure both the self reported experiences of stigma and the impact of stigma
Time Frame
Changes from Baseline to 3 months, 6 months, 9 months and 12 months
Title
Motivation for Treatment Questionnaire - 8 item ( MTQ 8)
Description
The motivation for Treatment Questionnaire( MTQ-8) consists of eight questions to assess motivational reasons to seek treatment.
Time Frame
Changes from Baseline to 3 months, 6 months,9months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Suppes, MD, PhD
Organizational Affiliation
VA Palo Alto Health Care System & Stanford University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Healthcare System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29931798
Citation
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.
Results Reference
derived
PubMed Identifier
26462799
Citation
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.
Results Reference
derived
Links:
URL
http://moodswings.net.au/
Description
MoodSwings Website

Learn more about this trial

Internet-Based Interventions for Bipolar Disorder

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