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

NCT03197974 | Completed

• 2 other identifiers: ORBITAPP1102097
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder, Currently in Remission

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Brief QoL.BD

  Self-report measure to assess quality of life.

  Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.

Secondary Outcomes (8)

• Change in Montgomery-Asberg Depression Scale (MADRS)

  Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.

• Change in Young Mania Rating Scale (YMRS)

  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)

  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)

  Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.

• Change in Functional Assessment Staging Test (FAST)

  Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.

Other Outcomes (11)

• Change in Resource Use Questionnaire

  Baseline, 3 and 6 months.

• Change in Assessment of Quality of Life 8dimension (AQol8d)

  Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.

• Change in Five Facet Mindfulness Questionnaire (FMQ)

  Baseline, immediately post-intervention (post the 5 week active phase), 3 and 6 months.

Study Arms (2)

Mindfulness for Bipolar

OTHER

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

Psychoeducation for Bipolar

OTHER

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

Interventions

Mindfulness for Bipolar BEHAVIORAL

Brief online self-management program with email coaching support

Mindfulness for Bipolar

Psychoeducation for Bipolar BEHAVIORAL

Brief online self-management program with email coaching support

Psychoeducation for Bipolar

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• currently experiencing an episode of depression or hypo/mania
• currently psychotic or actively suicidal

Sponsors & Collaborators

• Swinburne University of Technology: lead
• University of British Columbia: collaborator
• National Health and Medical Research Council, Australia: collaborator
• University of California, Berkeley: collaborator
• Lancaster University: collaborator
• Deakin University: collaborator
• Australian National University: collaborator

Study Sites (1)

Swinburne University of Technology

Hawthorn, Victoria, 3122, Australia

Location

Related Publications (1)

• 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.

  PMID: 30001704 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Greg Murray

  Swinburne University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 23, 2017
• Study Start: September 14, 2017
• Primary Completion: May 29, 2019
• Study Completion: May 29, 2019
• Last Updated: December 1, 2020

Record last verified: 2020-11

Locations

AU (1)