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

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ClinicalTrials.gov Identifier: NCT03197974
Recruitment Status : Active, not recruiting
First Posted : June 23, 2017
Last Update Posted : April 5, 2019
Sponsor:
Collaborators:
University of British Columbia
National Health and Medical Research Council, Australia
University of California, Berkeley
Lancaster University
Deakin University
Australian National University
Information provided by (Responsible Party):
Swinburne University of Technology

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder, Currently in Remission Behavioral: Mindfulness for Bipolar Behavioral: Psychoeducation for Bipolar Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Other
Official Title: Web-based Intervention With Email Support to Improve Quality of Life in Late Stage Bipolar Disorder (ORBIT): Randomised Controlled Trial
Actual Study Start Date : September 14, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Other Outcome Measures:
  1. Change in Resource Use Questionnaire [ Time Frame: Baseline, 3 and 6 months. ]
    A self-report measure of health service use.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197974


Locations
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Australia, Victoria
Swinburne University of Technology
Hawthorn, Victoria, Australia, 3122
Sponsors and Collaborators
Swinburne University of Technology
University of British Columbia
National Health and Medical Research Council, Australia
University of California, Berkeley
Lancaster University
Deakin University
Australian National University
Investigators
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Principal Investigator: Greg Murray Swinburne University of Technology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Swinburne University of Technology
ClinicalTrials.gov Identifier: NCT03197974     History of Changes
Other Study ID Numbers: ORBIT
APP1102097 ( Other Grant/Funding Number: National Health and Medical Research Council Australia )
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Swinburne University of Technology:
stage
online
self-help
coaching support
quality of life
mindfulness
psychoeducation
persuasive systems design
psychosocial

Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders