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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03197974
Ethics application status
Date submitted
21/06/2017
Date registered
23/06/2017

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
BEHAVIORAL - Mindfulness for Bipolar
BEHAVIORAL - 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


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

BEHAVIORAL: Psychoeducation for Bipolar
Brief online self-management program with email coaching support
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Brief QoL.BD
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)
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)
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)
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)
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)
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)
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)
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
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/05/2019
Sample size
Target
Accrual to date
Final
302
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03197974