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RCT of a Web-based Intervention to Improve Quality of Life in Late Stage Bipolar Disorder (ORBIT)

NCT ID: NCT03197974

Last Updated: 2020-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-14

Study Completion Date

2019-05-29

Brief Summary

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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.

Detailed Description

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People who have had significant experience with bipolar disorder (defined here as 10 or more episodes) may not benefit from existing psychosocial interventions targeting symptoms and relapse, and may be better served by interventions targeting quality of life (QoL). Our international team of researchers, clinicians and consumers has developed two different online interventions, both of which there is reason to believe will be useful. Both interventions are brief, with 4 weeks of new online content released weekly, plus one additional week of application. This 5-week 'active phase' is supported by email contact with a personal online coach. The remainder of the 6 months of participant involvement in the trial includes continued access to the website (without coaching support) and follow-up assessments. Both arms are equivalent in using cutting-edge internet technologies and design features to help people engage with the therapeutic content and generalise it into their real lives. The websites have been developed following best-practice principles of persuasive system design, and rely heavily on consumer videos, social engagement through discussion boards, personalised feedback, and intuitive content structure to maximise engagement.

Australia's NHMRC has funded a 4-year project (2016-2019) to develop and compare the effectiveness of the two websites in terms of a range of outcomes, primarily QoL. The randomized controlled trial (RCT) will definitively assess the QoL benefits of two websites for late stage Bipolar Disorder. The RCT has been designed to optimise various aims: minimise risk of bias to support definitive scientific findings (internal validity), support ready dissemination should outcomes be positive (external validity, end-user involvement), and to optimally manage the risks inherent in the population being studied. We expect to find definitive evidence of the comparative QoL benefits of the two interventions, and insights about secondary outcomes including self-rated state anxiety, self-rated depression, and clinician-rated depression. A number of clinical and functional secondary outcomes will also be explored, as will hypothesised mediators and baseline moderators of QoL outcomes. Economic analysis based on cost-consequence analysis, and a range of process evaluations will also be conducted.

A total of 300 participants will be block randomised to provide power to identify a small-moderate treatment effect on QoL. Participants will be blinded as to the experimental intervention. The study uses a single-site (internet-based) design, with advertising occurring primarily online, but also through traditional methods via clinical networks of the researchers in Australia, United Kingdom (UK), Canada and the US. Major assessment time points are baseline, post-treatment (primary endpoint), 3 months post-baseline and 6 months post-baseline. Participants will be remunerated for assessments, which include both online questionnaires and a (blinded) semi-structured clinical interview by phone.

A multi-layered risk-management approach has been developed based on our experience with online interventions for bipolar disorder and psychosis. First and foremost, we explain to participants that their participation does not replace usual care, and no emergency assistance is available through the website (a link to the international site unsuicide is provided). This devolving of responsibility to the participant is reinforced by the inclusion criterion of being under the care of a medical practitioner and having access to local emergency services. Second, both intervention sites contain general information about the potential risks (e.g., generating distress) of the interventions, as well as specific alerts to the potential challenges of particular exercises. Third, a comprehensive 'red flag decision tree' has been developed to guide the team's response to any risk issues arising (see Table 2). Finally, any adverse events arising will be reviewed weekly in the trial executive committee.

Conditions

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Bipolar Disorder, Currently in Remission

Keywords

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stage online self-help coaching support quality of life mindfulness psychoeducation persuasive systems design psychosocial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is a prospective, parallel group, rater-blind, superiority RCT with a 1:1 allocation ratio comparing two websites designed to improve QoL in late stage bipolar disorder. Follow-up time points are immediate post-treatment (primary outcome timepoint), 3-month and 6-month follow-ups. To minimise the risk of bias, we are not publicising which arm is expected to be superior in terms of the primary outcome. Note that we expect that both arms will lead to QoL benefits, and the statistical analysis plan is agnostic about the superiority of the experimental intervention over active control on a number of secondary outcome variables. In both arms, usual management will continue throughout, with medication and psychosocial intervention changes monitored at follow-up interviews. The study setting is online, and participation in both arms will be through a secure server at Swinburne University's National eTherapy Centre (NetC).
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Outcomes Assessors will be blinded as to treatment allocation. To maintain blinding, the Assessor will not be involved in intervention delivery and participants will be instructed not to discuss treatment with their interviewer. When an interview leads to unblinding, the assessor will be replaced.

Participants will be blinded as to the primary hypothesis of which website will have superior benefits for QoL, but will of course be aware of the intervention they receive.

Study Groups

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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.

Group Type OTHER

Mindfulness for Bipolar

Intervention Type BEHAVIORAL

Brief online self-management program with email coaching support

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

Group Type OTHER

Psychoeducation for Bipolar

Intervention Type BEHAVIORAL

Brief online self-management program with email coaching support

Interventions

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Mindfulness for Bipolar

Brief online self-management program with email coaching support

Intervention Type BEHAVIORAL

Psychoeducation for Bipolar

Brief online self-management program with email coaching support

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* currently experiencing an episode of depression or hypo/mania
* currently psychotic or actively suicidal
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role collaborator

National Health and Medical Research Council, Australia

OTHER

Sponsor Role collaborator

University of California, Berkeley

OTHER

Sponsor Role collaborator

Lancaster University

OTHER

Sponsor Role collaborator

Deakin University

OTHER

Sponsor Role collaborator

Australian National University

OTHER

Sponsor Role collaborator

Swinburne University of Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Greg Murray

Role: PRINCIPAL_INVESTIGATOR

Swinburne University of Technology

Locations

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Swinburne University of Technology

Hawthorn, Victoria, Australia

Site Status

Countries

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Australia

References

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Fletcher K, Foley F, Thomas N, Michalak E, Berk L, Berk M, Bowe S, Cotton S, Engel L, Johnson SL, Jones S, Kyrios M, Lapsley S, Mihalopoulos C, Perich T, Murray G. Web-based intervention to improve quality of life in late stage bipolar disorder (ORBIT): randomised controlled trial protocol. BMC Psychiatry. 2018 Jul 13;18(1):221. doi: 10.1186/s12888-018-1805-9.

Reference Type DERIVED
PMID: 30001704 (View on PubMed)

Other Identifiers

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APP1102097

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ORBIT

Identifier Type: -

Identifier Source: org_study_id