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

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dc.contributor.authorFletcher, Kathryn
dc.contributor.authorFoley, Fiona
dc.contributor.authorThomas, Neil
dc.contributor.authorMichalak, Erin
dc.contributor.authorBerk, Lesley
dc.contributor.authorBerk, Michael
dc.contributor.authorBowe, Steve
dc.contributor.authorCotton, Sue
dc.contributor.authorEngel, Lidia
dc.contributor.authorJohnson, Sheri L
dc.contributor.authorJones, Steven
dc.contributor.authorKyrios, Michael
dc.contributor.authorLapsley, Sara
dc.contributor.authorMihalopoulos, Cathrine
dc.contributor.authorPerich, Tania
dc.contributor.authorMurray, Greg
dc.date.accessioned2018-08-16T05:15:54Z
dc.date.available2018-08-16T05:15:54Z
dc.date.issued2018-07-13
dc.date.updated2018-07-20T04:00:11Z
dc.descriptionThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
dc.description.abstractBackground 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.en_US
dc.description.sponsorshipThis trial is funded by the Australian National Health and Medical Research Council (NHMRC; APP1102097). Funding is augmented by Swinburne University of Technology, the host organisation and the location of the HREC from which ethical approval was sought. MB is supported by an NHMRC Senior Principal Research Fellowship (APP1059660). GM has received Project Grant funding from the NHMRC, beyondblue and CIHR, and personal fees from Servier and CSL biotherapies. SC has received funding from NHMRC, beyondblue, Movember, Stanley Medical Research Institute, and American Foundation for Suicide Prevention.en_US
dc.identifier.citationFletcher, K., Foley, F., Thomas, N., Michalak, E., Berk, L., Berk, M., Bowe, S., Cotton, S., Engel, L., Johnson, S. L., Jones, S., Kyrios, M., Lapsley, S., Mihalopoulos, C., Perich, T., & Murray, G., (2018). Web-based intervention to improve quality of life in late stage bipolar disorder (ORBIT): randomised controlled trial protocol. BMC Psychiatry, 18(1):221.
dc.identifier.doihttps://doi.org/10.1186/s12888-018-1805-9
dc.identifier.issn1471-244X
dc.identifier.urihttp://hdl.handle.net/2328/38189
dc.language.isoenen
dc.oaire.license.condition.licenseCC-BY
dc.relationhttp://purl.org/au-research/grants/nhmrc/1102097en
dc.relationhttp://purl.org/au-research/grants/nhmrc/1059660en
dc.relation.grantnumberNHMRC/APP1102097en
dc.relation.grantnumberNHMRC/APP1059660en
dc.rightsThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
dc.rights.holderThe Author(s).
dc.subjectRandomised controlled trial (RCT)
dc.subjectBipolar disorder
dc.subjectWeb-based intervention
dc.subjectMindfulness
dc.subjectPsychoeducation
dc.subjectQuality of life
dc.subjectStage
dc.subjectDepression
dc.subjectMania
dc.titleWeb-based intervention to improve quality of life in late stage bipolar disorder (ORBIT): randomised controlled trial protocol
dc.typeArticleen
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