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

November 29, 2020 updated by: Swinburne University of Technology

Web-based Intervention With Email Support to Improve Quality of Life in Late Stage Bipolar Disorder (ORBIT): Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Hawthorn, Victoria, Australia, 3122
        • Swinburne University of Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Mindfulness for Bipolar
Brief online self-management program with email coaching support
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: Psychoeducation for Bipolar
Brief online self-management program with email coaching support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Brief QoL.BD
Time Frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Self-report measure to assess quality of life.
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Montgomery-Asberg Depression Scale (MADRS)
Time Frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
A clinician-rated scale to assess depression symptoms.
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Young Mania Rating Scale (YMRS)
Time Frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
A clinician-rated scale to assess manic symptoms.
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR)
Time Frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
A self-report measure of depression.
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Depression Anxiety Stress Scale (DASS-21, Anxiety and Stress Scales only)
Time Frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
A self-report measure of anxiety and stress symptoms.
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Functional Assessment Staging Test (FAST)
Time Frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
A clinician-rated scale to assess functioning across 6 different domains.
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
A self-report measure of sleep quality.
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Sleep, Circadian Rhythms and Mood questionnaire (SCRAM)
Time Frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
A self-report measure to assess overlap between sleep, circadian rhythms and mood.
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Occurrence of intervention-related relapse
Time Frame: Immediately post-intervention (post the 5 week active phase), 3 and 6 months.
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.
Immediately post-intervention (post the 5 week active phase), 3 and 6 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Resource Use Questionnaire
Time Frame: Baseline, 3 and 6 months.
A self-report measure of health service use.
Baseline, 3 and 6 months.
Change in Assessment of Quality of Life 8dimension (AQol8d)
Time Frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
A self-report measure of quality of life.
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Five Facet Mindfulness Questionnaire (FMQ)
Time Frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
A self-report measure of mindfulness.
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Self-Compassion Scale (SCS)
Time Frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
A self-report measure of self-compassion.
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Difficulties in Emotion Regulation Scale-16 Item (DERS-16)
Time Frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
A self-report measure to assess multiple aspects of emotion dysregulation.
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Ruminative Responses Scale (section of the Response Styles Questionnaire)
Time Frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
A self-report measure of tendency to ruminate.
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Responses to Positive Affect scale (RPA)
Time Frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
A self-report measure to assess rumination and dampening.
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Non-attachment to Ego Scale
Time Frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
A self-report measure to assess non-attachment to self.
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in Depressive Experience Questionnaire Self-Criticism Six-Item Scale (DEQ-SC6)
Time Frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
A self-report measure to assess self-criticism.
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in the Short revised almost perfect scale (SAPS)
Time Frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
A self-report measure to assess perfectionism.
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Change in adherence to medication.
Time Frame: Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.
Self-reported adherence to medication.
Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swinburne University of Technology

Collaborators

National Health and Medical Research Council, Australia
University of British Columbia
University of California, Berkeley
Australian National University
Lancaster University
Deakin University

Investigators

  • Principal Investigator: Greg Murray, Swinburne University of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 14, 2017

Primary Completion (ACTUAL)

May 29, 2019

Study Completion (ACTUAL)

May 29, 2019

Study Registration Dates

First Submitted

June 21, 2017

First Submitted That Met QC Criteria

June 21, 2017

First Posted (ACTUAL)

June 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2020

Last Update Submitted That Met QC Criteria

November 29, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORBIT
  • APP1102097 (OTHER_GRANT: National Health and Medical Research Council Australia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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