Bipolar DisorderNCT02118623
Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)
A study testing Moderated discussion board, Psychoeducation and Interactive Psychosocial Tools in people with Bipolar Disorder, run by University of Melbourne at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Moderated discussion board, Psychoeducation and Interactive Psychosocial Tools
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
University of Melbourne - Barwon Health
Geelong, Victoria, 3220
About this study
Official title: 1/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder
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.
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- Moderated discussion board, Psychoeducation, Interactive Psychosocial Tools
- Keywords
- Bipolar Disorder, Bipolar, Online intervention, Internet intervention, Self help
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderated discussion boardBehavioural
Also called discussion board, online discussion, online posts, online discussion boards
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.
PsychoeducationBehavioural
Also called Online psychoeducation, Online education, Education
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 ToolsBehavioural
Also called Interactive tools, Online tools, Online interactive 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 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".
| Study group | Role | What they receive |
|---|---|---|
| Level 1 | Active comparator | Moderated discussion board only Receives: Behavioral: Moderated discussion board |
| Level 2 | Active comparator | Moderated discussion board plus psychoeducation Receives: Behavioral: Moderated discussion board; Behavioral: Psychoeducation |
| Level 3 | Active comparator | Moderated discussion board plus psychoeducation plus interactive psychosocial tools. Receives: Behavioral: Moderated discussion board; Behavioral: Psychoeducation; Behavioral: Interactive Psychosocial Tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- VA Palo Alto Health Care System
- Responsible party
- Principal investigator, Michael Berk, University of Melbourne
- Investigators
- Michael Berk, FFPsych, PhD, Principal investigator, Deakin University and University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118623
- Sponsor's protocol ID
- 1R34MH091384
- Status last verified
- Oct 2017
- First submitted
- 15 Apr 2014
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29931798Gliddon 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.
PubMed 26462799
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT02118623
- Acronym / sponsor ID
- 1R34MH091384
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Bipolar, Online intervention, Internet intervention, Self help
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- VA Palo Alto Health Care System
- Study start
- Jan 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Level 1 | Active comparator | Behavioral: Moderated discussion boardModerated discussion board only |
| Level 2 | Active comparator | Behavioral: Moderated discussion board, Behavioral: PsychoeducationModerated discussion board plus psychoeducation |
| Level 3 | Active comparator | Behavioral: Moderated discussion board, Behavioral: Psychoeducation, Behavioral: Interactive Psychosocial ToolsModerated discussion board plus psychoeducation plus interactive psychosocial tools. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderated discussion boardAlso: discussion board, online discussion, online posts, online discussion boardsAll 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. | Behavioural | Level 1, Level 2, Level 3 |
| PsychoeducationAlso: Online psychoeducation, Online education, EducationOnline 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: 1. What is bipolar disorder? - Content about symptoms and diagnosis 2. Stress and triggers of illness 3. Medication and the biological basis of bipolar disorder 4. Depression - Symptoms, early detection and helpful strategies 5. Mania and hypomania - Symptoms, early detection and helpful strategies. | Behavioural | Level 2, Level 3 |
| Interactive Psychosocial ToolsAlso: Interactive tools, Online tools, Online interactive toolsOnline 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". | Behavioural | Level 3 |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 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)
Time frame: 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.
8 secondary outcomes
Time to Intervention for Mood Episode (TIME)
Time frame: Change from 3 months to 6 months, 9 months and 12 months
SF-12
Time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Cornell Service Index (CSI)
Time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Medication Adherence Rating Scale (MARS)
Time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Patient Satisfaction Questionnaire 18 (PSQ-18)
Time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Treatment Satisfaction Questionnaire-Modified
Time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Medical Outcomes Study Social Support Survey (MOS-SSS)
Time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Derived from this study: PubMed 29931798Gliddon 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.
- Derived from this study: PubMed 26462799Gliddon 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.
- MoodSwings websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Berk, FFPsych, PhD principal investigator
Deakin University and University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderated discussion board, Psychoeducation and Interactive Psychosocial Tools in people with Bipolar Disorder, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Change from Baseline to 3 months, 6 months, 9 months and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02118623, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.