Skip to main content
Top
Published in: BMC Psychiatry 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: 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

Published in: BMC Psychiatry | Issue 1/2018

Login to get access

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.

Trial registration

ClinicalTrials.​gov: NCT03197974. Registered 23 June 2017.
Appendix
Available only for authorised users
Literature
1.
go back to reference Merikangas KR, Akiskal HS, Angst J, Greenberg PE, Hirschfeld RM, Petukhova M, et al. Lifetime and 12-month prevalence of bipolar spectrum disorder in the National Comorbidity Survey replication. Arch Gen Psychiatry. 2007;64:543–52.CrossRefPubMedPubMedCentral Merikangas KR, Akiskal HS, Angst J, Greenberg PE, Hirschfeld RM, Petukhova M, et al. Lifetime and 12-month prevalence of bipolar spectrum disorder in the National Comorbidity Survey replication. Arch Gen Psychiatry. 2007;64:543–52.CrossRefPubMedPubMedCentral
2.
go back to reference Angst J, Sellaro R. Historical perspectives and natural history of bipolar disorder. Biol Psychiatry. 2000;48:445–57.CrossRefPubMed Angst J, Sellaro R. Historical perspectives and natural history of bipolar disorder. Biol Psychiatry. 2000;48:445–57.CrossRefPubMed
3.
go back to reference Magalhães PV, Dodd S, Nierenberg AA, Berk M. Cumulative morbidity and prognostic staging of illness in the systematic treatment enhancement program for bipolar disorder (STEP-BD). Aust N Z J Psychiatry. 2012;46:1058–67.CrossRefPubMed Magalhães PV, Dodd S, Nierenberg AA, Berk M. Cumulative morbidity and prognostic staging of illness in the systematic treatment enhancement program for bipolar disorder (STEP-BD). Aust N Z J Psychiatry. 2012;46:1058–67.CrossRefPubMed
4.
go back to reference Berk M, Post R, Ratheesh A, Gliddon E, Singh A, Vieta E, et al. Staging in bipolar disorder: from theoretical framework to clinical utility. World Psychiatry. 2017;16:236–44.CrossRefPubMedPubMedCentral Berk M, Post R, Ratheesh A, Gliddon E, Singh A, Vieta E, et al. Staging in bipolar disorder: from theoretical framework to clinical utility. World Psychiatry. 2017;16:236–44.CrossRefPubMedPubMedCentral
5.
go back to reference Kapczinski F, Vieta E, Andreazza AC, Frey BN, Gomes FA, Tramontina J, et al. Allostatic load in bipolar disorder: implications for pathophysiology and treatment. Neurosci Biobehav Rev. 2008;32:675–92.CrossRefPubMed Kapczinski F, Vieta E, Andreazza AC, Frey BN, Gomes FA, Tramontina J, et al. Allostatic load in bipolar disorder: implications for pathophysiology and treatment. Neurosci Biobehav Rev. 2008;32:675–92.CrossRefPubMed
6.
go back to reference Scott J, Paykel E, Morriss R, Bentall R, Kinderman P, Johnson T, et al. Cognitive-behavioural therapy for severe and recurrent bipolar disorders: randomised controlled trial. Br J Psychiatry. 2006;188:313–20.CrossRefPubMed Scott J, Paykel E, Morriss R, Bentall R, Kinderman P, Johnson T, et al. Cognitive-behavioural therapy for severe and recurrent bipolar disorders: randomised controlled trial. Br J Psychiatry. 2006;188:313–20.CrossRefPubMed
7.
go back to reference Berk M, Berk L, Udina M, Moylan S, Stafford L, Hallam K, et al. Palliative models of care for later stages of mental disorder: maximizing recovery, maintaining hope, and building morale. Aust N Z J Psychiatry. 2012;46:92–9.CrossRefPubMed Berk M, Berk L, Udina M, Moylan S, Stafford L, Hallam K, et al. Palliative models of care for later stages of mental disorder: maximizing recovery, maintaining hope, and building morale. Aust N Z J Psychiatry. 2012;46:92–9.CrossRefPubMed
8.
go back to reference Murray G, Leitan ND, Berk M, Thomas N, Michalak E, Berk L, et al. Online mindfulness-based intervention for late-stage bipolar disorder: pilot evidence for feasibility and effectiveness. J Affect Disord. 2015;178:46–51.CrossRefPubMed Murray G, Leitan ND, Berk M, Thomas N, Michalak E, Berk L, et al. Online mindfulness-based intervention for late-stage bipolar disorder: pilot evidence for feasibility and effectiveness. J Affect Disord. 2015;178:46–51.CrossRefPubMed
9.
go back to reference Hayes SC. Acceptance and commitment therapy, relational frame theory, and the third wave of behavioral and cognitive therapies. Behav Ther. 2004;35:639–65.CrossRef Hayes SC. Acceptance and commitment therapy, relational frame theory, and the third wave of behavioral and cognitive therapies. Behav Ther. 2004;35:639–65.CrossRef
10.
go back to reference Hayes SC, Villatte M, Levin M, Hildebrandt M. Open, aware, and active: contextual approaches as an emerging trend in the behavioral and cognitive therapies. Annu Rev Clin Psychol. 2011;7:141–68.CrossRefPubMed Hayes SC, Villatte M, Levin M, Hildebrandt M. Open, aware, and active: contextual approaches as an emerging trend in the behavioral and cognitive therapies. Annu Rev Clin Psychol. 2011;7:141–68.CrossRefPubMed
11.
go back to reference Kabat-Zinn J. Mindfulness-based interventions in context: past, present, and future. Clin Psychol Sci Prac. 2003;10:144–56.CrossRef Kabat-Zinn J. Mindfulness-based interventions in context: past, present, and future. Clin Psychol Sci Prac. 2003;10:144–56.CrossRef
12.
go back to reference Williams JM, Alatiq Y, Crane C, Barnhofer T, Fennell MJ, Duggan DS, et al. Mindfulness-based cognitive therapy (MBCT) in bipolar disorder: preliminary evaluation of immediate effects on between-episode functioning. J Affect Disord. 2008;107:275–9.CrossRefPubMedPubMedCentral Williams JM, Alatiq Y, Crane C, Barnhofer T, Fennell MJ, Duggan DS, et al. Mindfulness-based cognitive therapy (MBCT) in bipolar disorder: preliminary evaluation of immediate effects on between-episode functioning. J Affect Disord. 2008;107:275–9.CrossRefPubMedPubMedCentral
13.
go back to reference Perich T, Manicavasagar V, Mitchell PB, Ball JR. Mindfulness-based approaches in the treatment of bipolar disorder: potential mechanisms and effects. Mindfulness. 2014;5:186–91.CrossRef Perich T, Manicavasagar V, Mitchell PB, Ball JR. Mindfulness-based approaches in the treatment of bipolar disorder: potential mechanisms and effects. Mindfulness. 2014;5:186–91.CrossRef
14.
go back to reference Bos EH, Merea R, Brink E, Sanderman R, Bartels-Velthuis AA. Mindfulness training in a heterogeneous psychiatric sample: outcome evaluation and comparison of different diagnostic groups. J Clin Psychol. 2014;70:60–71.CrossRefPubMed Bos EH, Merea R, Brink E, Sanderman R, Bartels-Velthuis AA. Mindfulness training in a heterogeneous psychiatric sample: outcome evaluation and comparison of different diagnostic groups. J Clin Psychol. 2014;70:60–71.CrossRefPubMed
15.
go back to reference Deckersbach T, Hölzel BK, Eisner LR, Stange JP, Peckham AD, Dougherty DD, et al. Mindfulness-based cognitive therapy for nonremitted patients with bipolar disorder. CNS Neurosci Ther. 2012;18:133–41.CrossRefPubMed Deckersbach T, Hölzel BK, Eisner LR, Stange JP, Peckham AD, Dougherty DD, et al. Mindfulness-based cognitive therapy for nonremitted patients with bipolar disorder. CNS Neurosci Ther. 2012;18:133–41.CrossRefPubMed
16.
go back to reference Perich T, Manicavasagar V, Mitchell PB, Ball J, Hadzi-Pavlovic D. A randomized controlled trial of mindfulness-based cognitive therapy for bipolar disorder. Acta Psychiatr Scand. 2013;127:333–43.CrossRefPubMed Perich T, Manicavasagar V, Mitchell PB, Ball J, Hadzi-Pavlovic D. A randomized controlled trial of mindfulness-based cognitive therapy for bipolar disorder. Acta Psychiatr Scand. 2013;127:333–43.CrossRefPubMed
17.
go back to reference Meadows GN, Shawyer F, Enticott JC, Graham AL, Judd F, Martin PR, et al. Mindfulness-based cognitive therapy for recurrent depression: a translational research study with 2-year follow-up. Aust N Z J Psychiatry. 2014;48:743–55.CrossRefPubMed Meadows GN, Shawyer F, Enticott JC, Graham AL, Judd F, Martin PR, et al. Mindfulness-based cognitive therapy for recurrent depression: a translational research study with 2-year follow-up. Aust N Z J Psychiatry. 2014;48:743–55.CrossRefPubMed
18.
go back to reference Chu C, Stubbs B, Chen T, Tang C, Li D, Yang W, et al. The effectiveness of adjunct mindfulness-based intervention in treatment of bipolar disorder: a systematic review and meta-analysis. J Affect Disord. 2018;225:234–45.CrossRefPubMed Chu C, Stubbs B, Chen T, Tang C, Li D, Yang W, et al. The effectiveness of adjunct mindfulness-based intervention in treatment of bipolar disorder: a systematic review and meta-analysis. J Affect Disord. 2018;225:234–45.CrossRefPubMed
19.
go back to reference Martins MJRV, Castilho P, Carvalho CB, Pereira AT, Santos V, Gumley A, et al. Contextual cognitive-behavioral therapies across the psychosis continuum. Eur Psychol. 2017;22:83–100.CrossRef Martins MJRV, Castilho P, Carvalho CB, Pereira AT, Santos V, Gumley A, et al. Contextual cognitive-behavioral therapies across the psychosis continuum. Eur Psychol. 2017;22:83–100.CrossRef
20.
go back to reference Leitan ND, Michalak EE, Berk L, Berk M, Murray G. Optimizing delivery of recovery-oriented online self-management strategies for bipolar disorder: a review. Bipolar Disord. 2015;17:115–27.CrossRefPubMed Leitan ND, Michalak EE, Berk L, Berk M, Murray G. Optimizing delivery of recovery-oriented online self-management strategies for bipolar disorder: a review. Bipolar Disord. 2015;17:115–27.CrossRefPubMed
21.
go back to reference Griffiths KM, Farrer L, Christensen H. The efficacy of internet interventions for depression and anxiety disorders: a review of randomised controlled trials. Med J Aust. 2010;192:S4.PubMed Griffiths KM, Farrer L, Christensen H. The efficacy of internet interventions for depression and anxiety disorders: a review of randomised controlled trials. Med J Aust. 2010;192:S4.PubMed
22.
go back to reference Todd NJ, Jones SH, Hart A, Lobban FA. A web-based self-management intervention for bipolar disorder ‘living with bipolar’: a feasibility randomised controlled trial. J Affect Disord. 2014;169:21–9.CrossRefPubMed Todd NJ, Jones SH, Hart A, Lobban FA. A web-based self-management intervention for bipolar disorder ‘living with bipolar’: a feasibility randomised controlled trial. J Affect Disord. 2014;169:21–9.CrossRefPubMed
23.
go back to reference Lobban F, Dodd AL, Sawczuk AP, Asar O, Dagnan D, Diggle PJ, et al. Assessing feasibility and acceptability of web-based enhanced relapse prevention for bipolar disorder (ERPonline): a randomized controlled trial. J Med Internet Res. 2017;24(19):e85.CrossRef Lobban F, Dodd AL, Sawczuk AP, Asar O, Dagnan D, Diggle PJ, et al. Assessing feasibility and acceptability of web-based enhanced relapse prevention for bipolar disorder (ERPonline): a randomized controlled trial. J Med Internet Res. 2017;24(19):e85.CrossRef
24.
go back to reference Krusche A, Cyhlarova E, Williams JM. Mindfulness online: an evaluation of the feasibility of a web-based mindfulness course for stress, anxiety and depression. BMJ Open. 2013;3:e003498.CrossRefPubMedPubMedCentral Krusche A, Cyhlarova E, Williams JM. Mindfulness online: an evaluation of the feasibility of a web-based mindfulness course for stress, anxiety and depression. BMJ Open. 2013;3:e003498.CrossRefPubMedPubMedCentral
25.
go back to reference Pots WT, Fledderus M, Meulenbeek PA, ten Klooster PM, Schreurs KM, Bohlmeijer ET. Acceptance and commitment therapy as a web-based intervention for depressive symptoms: randomised controlled trial. Br J Psychiatry. 2016;208:69–77.CrossRefPubMed Pots WT, Fledderus M, Meulenbeek PA, ten Klooster PM, Schreurs KM, Bohlmeijer ET. Acceptance and commitment therapy as a web-based intervention for depressive symptoms: randomised controlled trial. Br J Psychiatry. 2016;208:69–77.CrossRefPubMed
26.
go back to reference Khoury B, Lecomte T, Gaudiano BA, Paquin K. Mindfulness interventions for psychosis: a meta-analysis. Schizophr Res. 2013;150:176–84.CrossRefPubMed Khoury B, Lecomte T, Gaudiano BA, Paquin K. Mindfulness interventions for psychosis: a meta-analysis. Schizophr Res. 2013;150:176–84.CrossRefPubMed
27.
go back to reference Kuyken W, Byford S, Taylor RS, Watkins E, Holden E, White K, et al. Mindfulness-based cognitive therapy to prevent relapse in recurrent depression. J Consult Clin Psychol. 2008;76:966.CrossRefPubMed Kuyken W, Byford S, Taylor RS, Watkins E, Holden E, White K, et al. Mindfulness-based cognitive therapy to prevent relapse in recurrent depression. J Consult Clin Psychol. 2008;76:966.CrossRefPubMed
28.
go back to reference Clarke S, Kingston J, Wilson KG, Bolderston H, Remington B. Acceptance and commitment therapy for a heterogeneous group of treatment-resistant clients: a treatment development study. Cog Beh Prac. 2012;19:560–72.CrossRef Clarke S, Kingston J, Wilson KG, Bolderston H, Remington B. Acceptance and commitment therapy for a heterogeneous group of treatment-resistant clients: a treatment development study. Cog Beh Prac. 2012;19:560–72.CrossRef
29.
go back to reference Farhall J, Shawyer F, Thomas N, Hayes S, Castle D, Copolov D. The Lifengage RCT of ACT for people with persisting positive symptoms of psychosis: initial results. Sydney: Paper presented at the ACBS World Conference; 2013. Farhall J, Shawyer F, Thomas N, Hayes S, Castle D, Copolov D. The Lifengage RCT of ACT for people with persisting positive symptoms of psychosis: initial results. Sydney: Paper presented at the ACBS World Conference; 2013.
30.
go back to reference Davis L, Kurzban S. Mindfulness-based treatment for people with severe mental illness: a literature review. Am J Psychiatr Rehabili. 2012;15:202–32.CrossRef Davis L, Kurzban S. Mindfulness-based treatment for people with severe mental illness: a literature review. Am J Psychiatr Rehabili. 2012;15:202–32.CrossRef
31.
go back to reference Stange J, Eisner L, Holzel B, Peckham A, Dougherty D, Rauch S, et al. Effects of mindfulness-based cognitive therapy on executive functioning in non-remitted individuals with bipolar disorder. Bipolar Disord. 2011;13:94. Stange J, Eisner L, Holzel B, Peckham A, Dougherty D, Rauch S, et al. Effects of mindfulness-based cognitive therapy on executive functioning in non-remitted individuals with bipolar disorder. Bipolar Disord. 2011;13:94.
32.
go back to reference Stange JP, Eisner LR, Holzel BK, Peckham AD, Dougherty DD, Rauch SL, et al. Mindfulness-based cognitive therapy for bipolar disorder: effects on cognitive functioning. J Psychiatr Pract. 2011;17:410–9.CrossRefPubMedPubMedCentral Stange JP, Eisner LR, Holzel BK, Peckham AD, Dougherty DD, Rauch SL, et al. Mindfulness-based cognitive therapy for bipolar disorder: effects on cognitive functioning. J Psychiatr Pract. 2011;17:410–9.CrossRefPubMedPubMedCentral
33.
go back to reference Michalak EE, Murray G. Development of the QoL. BD: a disorderspecific scale to assess quality of life in bipolar disorder. Bipolar Disord. 2010;12:727–40.CrossRefPubMed Michalak EE, Murray G. Development of the QoL. BD: a disorderspecific scale to assess quality of life in bipolar disorder. Bipolar Disord. 2010;12:727–40.CrossRefPubMed
34.
go back to reference Abraham J. The international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. In: Tietje C, Brouder A, editors. Handbook of transnational economic governance regimes. Leiden: Martinus Nijhoff Publishers; 2009. p. 1041–54. Abraham J. The international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. In: Tietje C, Brouder A, editors. Handbook of transnational economic governance regimes. Leiden: Martinus Nijhoff Publishers; 2009. p. 1041–54.
35.
go back to reference Chan A, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.CrossRefPubMedPubMedCentral Chan A, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.CrossRefPubMedPubMedCentral
36.
go back to reference Eysenbach G. CONSORT-EHEALTH Group CONSORT-EHEALTH: improving and standardizing evaluation reports of web-based and mobile health interventions. J Med Internet Res. 2011;13:e126.CrossRefPubMedPubMedCentral Eysenbach G. CONSORT-EHEALTH Group CONSORT-EHEALTH: improving and standardizing evaluation reports of web-based and mobile health interventions. J Med Internet Res. 2011;13:e126.CrossRefPubMedPubMedCentral
37.
go back to reference Sheehan D, Lecrubier Y, Sheehan K, Amorim P, Janavs J, Weiller E, et al. The Mini-international neuropsychiatric interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59:22–33.PubMed Sheehan D, Lecrubier Y, Sheehan K, Amorim P, Janavs J, Weiller E, et al. The Mini-international neuropsychiatric interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59:22–33.PubMed
38.
go back to reference Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, et al. The Columbia–suicide severity rating scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011;168:1266–77.CrossRefPubMedPubMedCentral Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, et al. The Columbia–suicide severity rating scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011;168:1266–77.CrossRefPubMedPubMedCentral
40.
go back to reference Todd NJ, Jones SH, Lobban FA. What do Service users with bipolar disorder want from a web-based self-management intervention? A qualitative focus group study. Clin Psychol Psychother. 2013;20:531–43.CrossRefPubMed Todd NJ, Jones SH, Lobban FA. What do Service users with bipolar disorder want from a web-based self-management intervention? A qualitative focus group study. Clin Psychol Psychother. 2013;20:531–43.CrossRefPubMed
41.
go back to reference Murray G, Leitan N, Michalak E, Berk L, Berk M. Supporting self-management in bipolar disorder online: a review. Bipolar Disord. 2015;17:23.CrossRef Murray G, Leitan N, Michalak E, Berk L, Berk M. Supporting self-management in bipolar disorder online: a review. Bipolar Disord. 2015;17:23.CrossRef
42.
go back to reference Lauder S, Chester A, Castle D, Dodd S, Gliddon E, Berk L, et al. A randomized head to head trial of MoodSwings.net.au: an internet based self-help program for bipolar disorder. J Affect Disord. 2015;171:13–21.CrossRefPubMed Lauder S, Chester A, Castle D, Dodd S, Gliddon E, Berk L, et al. A randomized head to head trial of MoodSwings.net.au: an internet based self-help program for bipolar disorder. J Affect Disord. 2015;171:13–21.CrossRefPubMed
43.
go back to reference Cosgrove V, Gliddon E, Berk L, Grimm D, Lauder S, Dodd S, et al. Online ethics: where will the interface of mental health and the internet lead us? Int J Bipolar Disord. 2017;5:26.CrossRefPubMedPubMedCentral Cosgrove V, Gliddon E, Berk L, Grimm D, Lauder S, Dodd S, et al. Online ethics: where will the interface of mental health and the internet lead us? Int J Bipolar Disord. 2017;5:26.CrossRefPubMedPubMedCentral
44.
go back to reference Kelders SM, Kok RN, Ossebaard HC, Van Gemert-Pijnen JE. Persuasive system design does matter: a systematic review of adherence to web-based interventions. J Med Internet Res. 2012;14:e152.CrossRefPubMedPubMedCentral Kelders SM, Kok RN, Ossebaard HC, Van Gemert-Pijnen JE. Persuasive system design does matter: a systematic review of adherence to web-based interventions. J Med Internet Res. 2012;14:e152.CrossRefPubMedPubMedCentral
45.
go back to reference Murray G, Leitan ND, Thomas N, Michalak EE, Johnson SL, Jones S, et al. Towards recovery-oriented psychosocial interventions for bipolar disorder: quality of life outcomes, stage-sensitive treatments, and mindfulness mechanisms. Clin Psychol Rev. 2017;52:148–63.CrossRefPubMed Murray G, Leitan ND, Thomas N, Michalak EE, Johnson SL, Jones S, et al. Towards recovery-oriented psychosocial interventions for bipolar disorder: quality of life outcomes, stage-sensitive treatments, and mindfulness mechanisms. Clin Psychol Rev. 2017;52:148–63.CrossRefPubMed
46.
go back to reference Thomas N, Farhall J, Foley F, Leitan ND, Villagonzalo K, Ladd E, et al. Promoting personal recovery in people with persisting psychotic disorders: development and pilot study of a novel digital intervention. Front Psychiatry. 2016;7:196.CrossRefPubMedPubMedCentral Thomas N, Farhall J, Foley F, Leitan ND, Villagonzalo K, Ladd E, et al. Promoting personal recovery in people with persisting psychotic disorders: development and pilot study of a novel digital intervention. Front Psychiatry. 2016;7:196.CrossRefPubMedPubMedCentral
47.
go back to reference Smith DJ, Griffiths E, Poole R, Di Florio A, Barnes E, Kelly MJ, et al. Beating bipolar: exploratory trial of a novel internet-based psychoeducational treatment for bipolar disorder. Bipolar Disord. 2011;13:571–7.CrossRefPubMed Smith DJ, Griffiths E, Poole R, Di Florio A, Barnes E, Kelly MJ, et al. Beating bipolar: exploratory trial of a novel internet-based psychoeducational treatment for bipolar disorder. Bipolar Disord. 2011;13:571–7.CrossRefPubMed
48.
go back to reference Colom F, Vieta E. Psychoeducation manual for bipolar disorder. Cambridge: Cambridge University Press; 2006.CrossRef Colom F, Vieta E. Psychoeducation manual for bipolar disorder. Cambridge: Cambridge University Press; 2006.CrossRef
49.
go back to reference Van Rheenen TE, Rossell SL. Objective and subjective psychosocial functioning in bipolar disorder: an investigation of the relative importance of neurocognition, social cognition and emotion regulation. J Affect Disord. 2014;162:134–41.CrossRefPubMed Van Rheenen TE, Rossell SL. Objective and subjective psychosocial functioning in bipolar disorder: an investigation of the relative importance of neurocognition, social cognition and emotion regulation. J Affect Disord. 2014;162:134–41.CrossRefPubMed
50.
go back to reference Fulford D, Peckham AD, Johnson K, Johnson SL. Emotion perception and quality of life in bipolar I disorder. J Affect Disord. 2014;152:491–7.CrossRefPubMed Fulford D, Peckham AD, Johnson K, Johnson SL. Emotion perception and quality of life in bipolar I disorder. J Affect Disord. 2014;152:491–7.CrossRefPubMed
51.
go back to reference Jones SH, Smith G, Mulligan LD, Lobban F, Law H, Dunn G, et al. Recovery-focused cognitive-behavioural therapy for recent-onset bipolar disorder: randomised controlled pilot trial. Br J Psychiatry. 2015;206:58–66.CrossRefPubMed Jones SH, Smith G, Mulligan LD, Lobban F, Law H, Dunn G, et al. Recovery-focused cognitive-behavioural therapy for recent-onset bipolar disorder: randomised controlled pilot trial. Br J Psychiatry. 2015;206:58–66.CrossRefPubMed
52.
go back to reference Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134:382–9.CrossRefPubMed Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134:382–9.CrossRefPubMed
53.
go back to reference Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978;133:429–35.CrossRefPubMed Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978;133:429–35.CrossRefPubMed
54.
go back to reference Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, et al. The 16-item quick inventory of depressive symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003;54:573–83.CrossRefPubMed Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, et al. The 16-item quick inventory of depressive symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003;54:573–83.CrossRefPubMed
55.
go back to reference Lovibond S, Lovibond P. Manual for the depression anxiety stress scales. 2nd ed. Sydney: Psychology Foundation; 1995. Lovibond S, Lovibond P. Manual for the depression anxiety stress scales. 2nd ed. Sydney: Psychology Foundation; 1995.
56.
go back to reference Rosa AR, Sánchez-Moreno J, Martínez-Aran A, Salamero M, Torrent C, Reinares M, et al. Validity and reliability of the functioning assessment short test (FAST) in bipolar disorder. Clin Pract Epi Mental Health. 2007;3:5.CrossRef Rosa AR, Sánchez-Moreno J, Martínez-Aran A, Salamero M, Torrent C, Reinares M, et al. Validity and reliability of the functioning assessment short test (FAST) in bipolar disorder. Clin Pract Epi Mental Health. 2007;3:5.CrossRef
57.
go back to reference Cacilhas AA, Magalhães PV d S, Ceresér KM, Walz JC, Weyne F, Rosa AR, et al. Bipolar disorder and age-related functional impairment. Rev Bras Psiquiatr. 2009;31:354–7.CrossRefPubMed Cacilhas AA, Magalhães PV d S, Ceresér KM, Walz JC, Weyne F, Rosa AR, et al. Bipolar disorder and age-related functional impairment. Rev Bras Psiquiatr. 2009;31:354–7.CrossRefPubMed
58.
go back to reference Cacilhas AA, Magalhães d S, Vieira P, Ceresér KM, Walz JC, Weyne F, Rosa AR, et al. Validity of a short functioning test (FAST) in Brazilian outpatients with bipolar disorder. Value Health. 2009;12:624–7.CrossRefPubMed Cacilhas AA, Magalhães d S, Vieira P, Ceresér KM, Walz JC, Weyne F, Rosa AR, et al. Validity of a short functioning test (FAST) in Brazilian outpatients with bipolar disorder. Value Health. 2009;12:624–7.CrossRefPubMed
59.
go back to reference Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28:193–213.CrossRefPubMed Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28:193–213.CrossRefPubMed
60.
61.
go back to reference Calabrese J, Montgomery S, Akhtar S, Hompland M, Olajossy M, Zieba A, Bowden C, et al. Lamotrigine demonstrates long-term mood stabilization in bipolar patients with recent episode of mania or hypomania. Eur Neuropsychopharmacol. 2001;11(3):S206. Calabrese J, Montgomery S, Akhtar S, Hompland M, Olajossy M, Zieba A, Bowden C, et al. Lamotrigine demonstrates long-term mood stabilization in bipolar patients with recent episode of mania or hypomania. Eur Neuropsychopharmacol. 2001;11(3):S206.
62.
go back to reference Richardson J, Khan M, Iezzi A. Preliminary results for the validation of the assessment of quality of life AQoL-8D instrument. Research paper 47: Monash University Centre for health economics; 2010. Richardson J, Khan M, Iezzi A. Preliminary results for the validation of the assessment of quality of life AQoL-8D instrument. Research paper 47: Monash University Centre for health economics; 2010.
63.
go back to reference Richardson J, Iezzi A, Khan MA, Maxwell A. Validity and reliability of the assessment of quality of life (AQoL)-8D multi-attribute utility instrument. Patient. 2014;7:85–96.CrossRefPubMed Richardson J, Iezzi A, Khan MA, Maxwell A. Validity and reliability of the assessment of quality of life (AQoL)-8D multi-attribute utility instrument. Patient. 2014;7:85–96.CrossRefPubMed
64.
go back to reference Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006;13:27–45.CrossRefPubMed Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006;13:27–45.CrossRefPubMed
65.
go back to reference Carmody J, Baer RA. Relationships between mindfulness practice and levels of mindfulness, medical and psychological symptoms and well-being in a mindfulness-based stress reduction program. J Behav Med. 2008;31:23–33.CrossRefPubMed Carmody J, Baer RA. Relationships between mindfulness practice and levels of mindfulness, medical and psychological symptoms and well-being in a mindfulness-based stress reduction program. J Behav Med. 2008;31:23–33.CrossRefPubMed
66.
go back to reference Bohlmeijer E, ten Klooster PM, Fledderus M, Veehof M, Baer R. Psychometric properties of the five facet mindfulness questionnaire in depressed adults and development of a short form. Assessment. 2011;18:308–20.CrossRefPubMed Bohlmeijer E, ten Klooster PM, Fledderus M, Veehof M, Baer R. Psychometric properties of the five facet mindfulness questionnaire in depressed adults and development of a short form. Assessment. 2011;18:308–20.CrossRefPubMed
67.
go back to reference Gu J, Strauss C, Crane C, Barnhofer T, Karl A, Cavanagh K, et al. Examining the factor structure of the 39-item and 15-item versions of the five facet mindfulness questionnaire before and after mindfulness-based cognitive therapy for people with recurrent depression. Psychol Assess. 2016;28:791.CrossRefPubMedPubMedCentral Gu J, Strauss C, Crane C, Barnhofer T, Karl A, Cavanagh K, et al. Examining the factor structure of the 39-item and 15-item versions of the five facet mindfulness questionnaire before and after mindfulness-based cognitive therapy for people with recurrent depression. Psychol Assess. 2016;28:791.CrossRefPubMedPubMedCentral
68.
go back to reference Neff KD. The development and validation of a scale to measure self-compassion. Self Identity. 2003;2:223–50.CrossRef Neff KD. The development and validation of a scale to measure self-compassion. Self Identity. 2003;2:223–50.CrossRef
69.
go back to reference Neff KD. The self-compassion scale is a valid and theoretically coherent measure of self-compassion. Mindfulness. 2016;7:264–74.CrossRef Neff KD. The self-compassion scale is a valid and theoretically coherent measure of self-compassion. Mindfulness. 2016;7:264–74.CrossRef
70.
go back to reference Døssing M, Nilsson KK, Svejstrup SR, Sørensen VV, Straarup KN, Hansen TB. Low self-compassion in patients with bipolar disorder. Compr Psychiatry. 2015;60:53–8.CrossRefPubMed Døssing M, Nilsson KK, Svejstrup SR, Sørensen VV, Straarup KN, Hansen TB. Low self-compassion in patients with bipolar disorder. Compr Psychiatry. 2015;60:53–8.CrossRefPubMed
71.
go back to reference Bjureberg J, Ljótsson B, Tull MT, Hedman E, Sahlin H, Lundh L, et al. Development and validation of a brief version of the difficulties in emotion regulation scale: the DERS-16. J Psychopathol Beh Assess. 2016;38:284–96.CrossRef Bjureberg J, Ljótsson B, Tull MT, Hedman E, Sahlin H, Lundh L, et al. Development and validation of a brief version of the difficulties in emotion regulation scale: the DERS-16. J Psychopathol Beh Assess. 2016;38:284–96.CrossRef
72.
go back to reference Treynor W, Gonzalez R, Nolen-Hoeksema S. Rumination reconsidered: a psychometric analysis. Cog Ther Res. 2003;27:247–59.CrossRef Treynor W, Gonzalez R, Nolen-Hoeksema S. Rumination reconsidered: a psychometric analysis. Cog Ther Res. 2003;27:247–59.CrossRef
73.
go back to reference Feldman GC, Joormann J, Johnson SL. Responses to positive affect: a self-report measure of rumination and dampening. Cog Ther Res. 2008;32:507.CrossRef Feldman GC, Joormann J, Johnson SL. Responses to positive affect: a self-report measure of rumination and dampening. Cog Ther Res. 2008;32:507.CrossRef
74.
go back to reference Gruber J, Eidelman P, Johnson SL, Smith B, Harvey AG. Hooked on a feeling: rumination about positive and negative emotion in inter-episode bipolar disorder. J Abnorm Psychol. 2011;120:956.CrossRefPubMedPubMedCentral Gruber J, Eidelman P, Johnson SL, Smith B, Harvey AG. Hooked on a feeling: rumination about positive and negative emotion in inter-episode bipolar disorder. J Abnorm Psychol. 2011;120:956.CrossRefPubMedPubMedCentral
75.
go back to reference Rudich Z, Lerman SF, Gurevich B, Weksler N, Shahar G. Patients’ self-criticism is a stronger predictor of physician’s evaluation of prognosis than pain diagnosis or severity in chronic pain patients. J Pain. 2008;9:210–6.CrossRefPubMed Rudich Z, Lerman SF, Gurevich B, Weksler N, Shahar G. Patients’ self-criticism is a stronger predictor of physician’s evaluation of prognosis than pain diagnosis or severity in chronic pain patients. J Pain. 2008;9:210–6.CrossRefPubMed
76.
go back to reference Rice KG, Richardson CM, Tueller S. The short form of the revised almost perfect scale. J Pers Assess. 2014;96:368–79.CrossRefPubMed Rice KG, Richardson CM, Tueller S. The short form of the revised almost perfect scale. J Pers Assess. 2014;96:368–79.CrossRefPubMed
77.
go back to reference Donkin L, Christensen H, Naismith SL, Neal B, Hickie IB, Glozier N. A systematic review of the impact of adherence on the effectiveness of e-therapies. J Med Internet Res. 2011;13:e52.CrossRefPubMedPubMedCentral Donkin L, Christensen H, Naismith SL, Neal B, Hickie IB, Glozier N. A systematic review of the impact of adherence on the effectiveness of e-therapies. J Med Internet Res. 2011;13:e52.CrossRefPubMedPubMedCentral
78.
go back to reference Szentagotai A, David D. The efficacy of cognitive-behavioral therapy in bipolar disorder: a quantitative meta-analysis. J Clin Psychiatry. 2010;71:66–72.CrossRefPubMed Szentagotai A, David D. The efficacy of cognitive-behavioral therapy in bipolar disorder: a quantitative meta-analysis. J Clin Psychiatry. 2010;71:66–72.CrossRefPubMed
79.
go back to reference Hutton J, Monaghan P. Choice of parametric accelerated life and proportional hazards models for survival data: asymptotic results. Lifetime Data Anal. 2002;8:375–93.CrossRefPubMed Hutton J, Monaghan P. Choice of parametric accelerated life and proportional hazards models for survival data: asymptotic results. Lifetime Data Anal. 2002;8:375–93.CrossRefPubMed
80.
go back to reference Hayes A. Introduction to mediation, moderation, and conditional process analysis: a regression-based approach. New York: Guildford; 2013. Hayes A. Introduction to mediation, moderation, and conditional process analysis: a regression-based approach. New York: Guildford; 2013.
81.
go back to reference Preacher KJ, Hayes AF. Asymptotic and resampling strategies for assessing and comparing indirect effects in multiple mediator models. Behav Res Methods. 2008;40:879–91.CrossRefPubMed Preacher KJ, Hayes AF. Asymptotic and resampling strategies for assessing and comparing indirect effects in multiple mediator models. Behav Res Methods. 2008;40:879–91.CrossRefPubMed
82.
go back to reference Mihalopoulos C, McCrone P, Knapp M, Johannessen JO, Malla A, McGorry P. The costs of early intervention in psychosis: restoring the balance. Aust N Z J Psychiatry. 2012;46:808–11.CrossRefPubMed Mihalopoulos C, McCrone P, Knapp M, Johannessen JO, Malla A, McGorry P. The costs of early intervention in psychosis: restoring the balance. Aust N Z J Psychiatry. 2012;46:808–11.CrossRefPubMed
83.
go back to reference Mihalopoulos C. Why invest in early psychosis intervention services? Early Interv Psychiatry. 2009;3:237–8.CrossRefPubMed Mihalopoulos C. Why invest in early psychosis intervention services? Early Interv Psychiatry. 2009;3:237–8.CrossRefPubMed
84.
go back to reference Reed SD, Anstrom KJ, Bakhai A, Briggs AH, Califf RM, Cohen DJ, et al. Conducting economic evaluations alongside multinational clinical trials: toward a research consensus. Am Heart J. 2005;149:434–43.CrossRefPubMed Reed SD, Anstrom KJ, Bakhai A, Briggs AH, Califf RM, Cohen DJ, et al. Conducting economic evaluations alongside multinational clinical trials: toward a research consensus. Am Heart J. 2005;149:434–43.CrossRefPubMed
85.
go back to reference Kost RG, Lee LM, Yessis J, Wesley RA, Henderson DK, Coller BS. Assessing participant-centered outcomes to improve clinical research. N Engl J Med. 2013;369:2179–81.CrossRefPubMedPubMedCentral Kost RG, Lee LM, Yessis J, Wesley RA, Henderson DK, Coller BS. Assessing participant-centered outcomes to improve clinical research. N Engl J Med. 2013;369:2179–81.CrossRefPubMedPubMedCentral
86.
go back to reference National Institute for Health Research. Good practice guidance for involving people with experience of mental health problems in research. London: National Health Service; 2013. National Institute for Health Research. Good practice guidance for involving people with experience of mental health problems in research. London: National Health Service; 2013.
88.
go back to reference Onnela JP, Rauch SL. Harnessing smartphone-based digital phenotyping to enhance behavioral and mental health. Neuropsychopharmacology. 2016;417:1691–6.CrossRef Onnela JP, Rauch SL. Harnessing smartphone-based digital phenotyping to enhance behavioral and mental health. Neuropsychopharmacology. 2016;417:1691–6.CrossRef
89.
go back to reference Berk M, Berk L, Dodd S, Cotton S, Macneil C, Daglas R, et al. Stage managing bipolar disorder. Bipolar Disord. 2014;16:471–7.CrossRefPubMed Berk M, Berk L, Dodd S, Cotton S, Macneil C, Daglas R, et al. Stage managing bipolar disorder. Bipolar Disord. 2014;16:471–7.CrossRefPubMed
Metadata
Title
Web-based intervention to improve quality of life in late stage bipolar disorder (ORBIT): randomised controlled trial protocol
Authors
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
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2018
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-018-1805-9

Other articles of this Issue 1/2018

BMC Psychiatry 1/2018 Go to the issue