Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02118623
Registration number
NCT02118623
Ethics application status
Date submitted
15/04/2014
Date registered
21/04/2014
Date last updated
26/10/2017
Titles & IDs
Public title
Internet-Based Interventions for Bipolar Disorder (MoodSwings 2)
Query!
Scientific title
1/2-A Randomized Trial of Internet-Based Interventions for Bipolar Disorder
Query!
Secondary ID [1]
0
0
1R34MH091384
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder
0
0
Query!
Condition category
Condition code
Mental Health
0
0
0
0
Query!
Other mental health disorders
Query!
Mental Health
0
0
0
0
Query!
Depression
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Behaviour - Moderated discussion board
Behaviour - Psychoeducation
Behaviour - Interactive Psychosocial Tools
Active Comparator: Level 1 - Moderated discussion board only
Active Comparator: Level 2 - Moderated discussion board plus psychoeducation
Active Comparator: Level 3 - Moderated discussion board plus psychoeducation plus interactive psychosocial tools.
Behaviour: 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.
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.
Behaviour: 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.
Behaviour: 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 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".
Query!
Intervention code [1]
0
0
Behaviour
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Montgomery-Asberg Depression Rating Scale (MADRS)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Query!
Primary outcome [2]
0
0
Young Mania Rating Scale (YMRS)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Query!
Secondary outcome [1]
0
0
Time to Intervention for Mood Episode (TIME)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Change from 3 months to 6 months, 9 months and 12 months
Query!
Secondary outcome [2]
0
0
SF-12
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Query!
Secondary outcome [3]
0
0
Cornell Service Index (CSI)
Query!
Assessment method [3]
0
0
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).
Query!
Timepoint [3]
0
0
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Query!
Secondary outcome [4]
0
0
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Query!
Secondary outcome [5]
0
0
Medication Adherence Rating Scale (MARS)
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Query!
Secondary outcome [6]
0
0
Patient Satisfaction Questionnaire 18 (PSQ-18)
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Query!
Secondary outcome [7]
0
0
Treatment Satisfaction Questionnaire-Modified
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Query!
Secondary outcome [8]
0
0
Medical Outcomes Study Social Support Survey (MOS-SSS)
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Change from Baseline to 3 months, 6 months, 9 months and 12 months
Query!
Eligibility
Key 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.
Query!
Minimum age
21
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Supportive Care
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/01/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/05/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
304
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
University of Melbourne - Barwon Health - Geelong
Query!
Recruitment postcode(s) [1]
0
0
3220 - Geelong
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University of Melbourne
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Government body
Query!
Name [1]
0
0
VA Palo Alto Health Care System
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02118623
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Michael Berk, FFPsych, PhD
Query!
Address
0
0
Deakin University and University of Melbourne
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02118623
Download to PDF