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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03197974




Registration number
NCT03197974
Ethics application status
Date submitted
21/06/2017
Date registered
23/06/2017
Date last updated
5/04/2019

Titles & IDs
Public title
RCT of a Web-based Intervention to Improve Quality of Life in Late Stage Bipolar Disorder (ORBIT)
Scientific title
Web-based Intervention With Email Support to Improve Quality of Life in Late Stage Bipolar Disorder (ORBIT): Randomised Controlled Trial
Secondary ID [1] 0 0
APP1102097
Secondary ID [2] 0 0
ORBIT
Universal Trial Number (UTN)
Trial acronym
ORBIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder, Currently in Remission 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Mindfulness for Bipolar
Behaviour - Psychoeducation for Bipolar

Other: Mindfulness for Bipolar - Introduction to, and training in the skills of mindfulness, self-compassion, and values-oriented action, and how these can be applied to managing symptoms of bipolar disorder.

Other: Psychoeducation for Bipolar - Information about bipolar disorder and the patient's role in managing the condition, including identifying triggers, and responding to early warning signs of episodes, and developing a healthy lifestyle


Behaviour: Mindfulness for Bipolar
Brief online self-management program with email coaching support

Behaviour: Psychoeducation for Bipolar
Brief online self-management program with email coaching support

Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Brief QoL.BD - Self-report measure to assess quality of life.
Timepoint [1] 0 0
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Secondary outcome [1] 0 0
Change in Montgomery-Asberg Depression Scale (MADRS) - A clinician-rated scale to assess depression symptoms.
Timepoint [1] 0 0
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Secondary outcome [2] 0 0
Change in Young Mania Rating Scale (YMRS) - A clinician-rated scale to assess manic symptoms.
Timepoint [2] 0 0
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Secondary outcome [3] 0 0
Change in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) - A self-report measure of depression.
Timepoint [3] 0 0
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Secondary outcome [4] 0 0
Change in Depression Anxiety Stress Scale (DASS-21, Anxiety and Stress Scales only) - A self-report measure of anxiety and stress symptoms.
Timepoint [4] 0 0
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Secondary outcome [5] 0 0
Change in Functional Assessment Staging Test (FAST) - A clinician-rated scale to assess functioning across 6 different domains.
Timepoint [5] 0 0
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Secondary outcome [6] 0 0
Change in Pittsburgh Sleep Quality Index (PSQI) - A self-report measure of sleep quality.
Timepoint [6] 0 0
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Secondary outcome [7] 0 0
Change in Sleep, Circadian Rhythms and Mood questionnaire (SCRAM) - A self-report measure to assess overlap between sleep, circadian rhythms and mood.
Timepoint [7] 0 0
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Secondary outcome [8] 0 0
Occurrence of intervention-related relapse - Using the Time to Intervention for Mood Episode (TIME) and a modified version of the MINI International Neuropsychiatric Interview (MINI) to determine treatment-related relapse events.
Timepoint [8] 0 0
Immediately post-intervention (post the 5 week active phase), 3 and 6 months.

Eligibility
Key inclusion criteria
To ensure ready translation, minimally restrictive inclusion and exclusion criteria will be
set.



- diagnosis of BD from a mental health professional

- diagnosis of BD (BD I, BD II or Other Specified Bipolar and Related Disorder)
confirmed by semi-structured interview using DSM-5 (Diagnostic and statistical manual
of mental disorders-5) criteria, excluding criteria that mania/hypomania require
abnormalities of activity/energy.

- must have experienced 10 or more episodes of mania, hypomania or depression

- must be under the care of and able to provide phone/mail contact details for a
nominated medical practitioner

- must have local access to emergency services

- must have sufficient understanding of written and spoken English

- must have ready daily access to the internet and adequate internet literacy

- aged between 18 - 65 years
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- currently experiencing an episode of depression or hypo/mania

- currently psychotic or actively suicidal

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Swinburne University of Technology - Hawthorn
Recruitment postcode(s) [1] 0 0
3122 - Hawthorn

Funding & Sponsors
Primary sponsor type
Other
Name
Swinburne University of Technology
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of British Columbia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Health and Medical Research Council, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of California, Berkeley
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Lancaster University
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Deakin University
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Australian National University
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this study is to improve outcomes in people with bipolar disorder (BD) by
comparing two new online interventions specifically designed to improve quality of life
amongst people who have had multiple (10 or more) episodes of BD.
Trial website
https://clinicaltrials.gov/show/NCT03197974
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Greg Murray
Address 0 0
Swinburne University of Technology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications