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Web-based intervention to improve quality of life in late stage bipolar disorder (ORBIT): randomised controlled trial protocol

Fletcher, Kathryn, Foley, Fiona, Thomas, Neil, Michalak, Erin, Berk, Lesley, Berk, Michael, Bowe, Steve, Cotton, Sue, Engel, Lidia, Johnson, Sheri L., Jones, Steven, Kyrios, Michael, Lapsley, Sara, Mihalopoulos, Cathrine, Perich, Tania and Murray, Greg 2018, Web-based intervention to improve quality of life in late stage bipolar disorder (ORBIT): randomised controlled trial protocol, BMC psychiatry, vol. 18, no. 1, pp. 1-13, doi: 10.1186/s12888-018-1805-9.

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Title Web-based intervention to improve quality of life in late stage bipolar disorder (ORBIT): randomised controlled trial protocol
Author(s) Fletcher, Kathryn
Foley, Fiona
Thomas, Neil
Michalak, Erin
Berk, LesleyORCID iD for Berk, Lesley orcid.org/0000-0002-3677-7503
Berk, MichaelORCID iD for Berk, Michael orcid.org/0000-0002-5554-6946
Bowe, SteveORCID iD for Bowe, Steve orcid.org/0000-0003-3813-842X
Cotton, Sue
Engel, LidiaORCID iD for Engel, Lidia orcid.org/0000-0002-7959-3149
Johnson, Sheri L.
Jones, Steven
Kyrios, Michael
Lapsley, Sara
Mihalopoulos, CathrineORCID iD for Mihalopoulos, Cathrine orcid.org/0000-0002-7127-9462
Perich, Tania
Murray, Greg
Journal name BMC psychiatry
Volume number 18
Issue number 1
Article ID 221
Start page 1
End page 13
Total pages 13
Publisher BioMed Central
Place of publication London, Eng.
Publication date 2018-07-13
ISSN 1471-244X
Keyword(s) Bipolar disorder
Depression
Mania
Mindfulness
Psychoeducation
Quality of life
Randomised controlled trial (RCT)
Stage
Web-based intervention
Science & Technology
Life Sciences & Biomedicine
Psychiatry
COGNITIVE-BEHAVIORAL THERAPY
FACET MINDFULNESS QUESTIONNAIRE
SELF-MANAGEMENT INTERVENTION
RECURRENT DEPRESSION
COMMITMENT THERAPY
CLINICAL-TRIALS
RATING-SCALE
SHORT-FORM
PSYCHOSIS
RECOVERY
Summary BACKGROUND: The primary objective of this randomised controlled trial (RCT) is to establish the effectiveness of a novel online quality of life (QoL) intervention tailored for people with late stage (≥ 10 episodes) bipolar disorder (BD) compared with psychoeducation. Relative to early stage individuals, this late stage group may not benefit as much from existing psychosocial treatments. The intervention is a guided self-help, mindfulness based intervention (MBI) developed in consultation with consumers, designed specifically for web-based delivery, with email coaching support. 

METHODS/DESIGN: This international RCT will involve a comparison of the effectiveness and cost-effectiveness of two 5-week adjunctive online self-management interventions: Mindfulness for Bipolar 2.0 and an active control (Psychoeducation for Bipolar). A total of 300 participants will be recruited primarily via social media channels. Main inclusion criteria are: a diagnosis of BD (confirmed via a phone-administered structured diagnostic interview), no current mood episode, history of 10 or more mood episodes, no current psychotic features or active suicidality, under the care of a medical practitioner. Block randomisation will be used for allocation to the interventions, and participants will retain access to the program for 6 months. Evaluations will be conducted at pre- and post- treatment, and at 3- and 6- months follow-up. The primary outcome measure will be the Brief Quality of Life in Bipolar Disorder Scale (Brief QoL.BD), collected immediately post-intervention at 5 weeks (T1). Secondary measures include BD-related symptoms (mania, depression, anxiety, stress), time to first relapse, functioning, sleep quality, social rhythm stability and resource use. Measurements will be collected online and via telephone assessments at baseline (T0), 5 weeks (T1), three months (T2) and six months (T3). Candidate moderators (diagnosis, anxiety or substance comorbidities, demographics and current treatments) will be investigated as will putative therapeutic mechanisms including mindfulness, emotion regulation and self-compassion. A cost-effectiveness analysis will be conducted. Acceptability and any unwanted events (including adverse treatment reactions) will be documented and explored. 

DISCUSSION: This definitive trial will test the effectiveness and cost-effectiveness of a novel QoL focused, mindfulness based, online guided self-help intervention for late stage BD, and investigate its putative mechanisms of therapeutic action.
Language eng
DOI 10.1186/s12888-018-1805-9
Field of Research 1103 Clinical Sciences
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2018, The Authors
Free to Read? Yes
Use Rights Creative Commons Attribution licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30111707

Document type: Journal Article
Collections: School of Medicine
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.