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

Kathryn Fletcher; Fiona Foley; Neil Thomas; Erin Michalak; Lesley Berk; Michael Berk; Steve Bowe; Sue Cotton; Lidia Engel; Sheri L. Johnson; Steven Jones; Michael Kyrios; Sara Lapsley; Cathrine Mihalopoulos; Tania Perich; Greg Murray

doi:10.1186/s12888-018-1805-9

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

Kathryn Fletcher, Fiona Foley, Neil Thomas, Erin Michalak, Lesley Berk, Michael Berk, Steve Bowe, Sue Cotton, Lidia Engel, Sheri L. Johnson, Steven Jones, Michael Kyrios, Sara Lapsley, Cathrine Mihalopoulos, Tania Perich, Greg Murray

Western Sydney University

Research output: Contribution to journal › Article › peer-review

Abstract

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.

Original language	English
Article number	221
Number of pages	13
Journal	BMC Psychiatry
Volume	18
Issue number	1
DOIs	https://doi.org/10.1186/s12888-018-1805-9
Publication status	Published - 2018

Open Access - Access Right Statement

© The Author(s). 2018 Open Access This 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.

Keywords

Internet
manic-depressive illness
quality of life
randomized controlled trials

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10.1186/s12888-018-1805-9

Cite this

Fletcher, 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), Article 221. https://doi.org/10.1186/s12888-018-1805-9

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abstract = "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.",

keywords = "Internet, manic-depressive illness, quality of life, randomized controlled trials",

author = "Kathryn Fletcher and Fiona Foley and Neil Thomas and Erin Michalak and Lesley Berk and Michael Berk and Steve Bowe and Sue Cotton and Lidia Engel and Johnson, {Sheri L.} and Steven Jones and Michael Kyrios and Sara Lapsley and Cathrine Mihalopoulos and Tania Perich and Greg Murray",

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doi = "10.1186/s12888-018-1805-9",

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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 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, 221. https://doi.org/10.1186/s12888-018-1805-9

TY - JOUR

T1 - Web-based intervention to improve quality of life in late stage bipolar disorder (ORBIT) : randomised controlled trial protocol

AU - Fletcher, Kathryn

AU - Foley, Fiona

AU - Thomas, Neil

AU - Michalak, Erin

AU - Berk, Lesley

AU - Berk, Michael

AU - Bowe, Steve

AU - Cotton, Sue

AU - Engel, Lidia

AU - Johnson, Sheri L.

AU - Jones, Steven

AU - Kyrios, Michael

AU - Lapsley, Sara

AU - Mihalopoulos, Cathrine

AU - Perich, Tania

AU - Murray, Greg

PY - 2018

Y1 - 2018

N2 - 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.

AB - 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.

KW - Internet

KW - manic-depressive illness

KW - quality of life

KW - randomized controlled trials

UR - http://handle.westernsydney.edu.au:8081/1959.7/uws:48116

U2 - 10.1186/s12888-018-1805-9

DO - 10.1186/s12888-018-1805-9

M3 - Article

SN - 1471-244x

VL - 18

JO - BMC Psychiatry

JF - BMC Psychiatry

IS - 1

M1 - 221

ER -

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

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