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Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Moderated discussion board
Psychoeducation
Interactive Psychosocial Tools
Sponsored by
University of Melbourne
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 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.

Sites / Locations

  • University of Melbourne - Barwon Health

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 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.
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.

Secondary Outcome Measures

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.
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.
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).
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.
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.
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.
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.
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
April 15, 2014
Last Updated
October 24, 2017
Sponsor
University of Melbourne
Collaborators
VA Palo Alto Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT02118623
Brief Title
Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)
Official Title
1/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

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
304 (Actual)

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. 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.
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 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".
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
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 (YMRS)
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 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.
Time Frame
Change from 3 months to 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 due to emotional problems.
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). 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 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.
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 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.
Time Frame
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Title
Patient Satisfaction Questionnaire 18 (PSQ-18)
Description
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.
Time Frame
Change 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 bipolar disorder and the MoodSwings 2.0 program. This questionnaire was originally a modified version of the Treatment Satisfaction Questionnaire.
Time Frame
Change 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
Change 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
Change 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
Change from Baseline to 3 months, 6 months, 9 months 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Berk, FFPsych, PhD
Organizational Affiliation
Deakin University and University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Melbourne - Barwon Health
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia

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://www.moodswings.net.au
Description
MoodSwings website

Learn more about this trial

Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)

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