Skip to main content
Top
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Balancing ACT: evaluating the effectiveness of psychoeducation and Acceptance and Commitment Therapy (ACT) groups for people with bipolar disorder: study protocol for pilot randomised controlled trial

Authors: Emma O’Donoghue, Abigail Clark, Matthew Richardson, John Hodsoll, Sunil Nandha, Eric Morris, Fergus Kane, Deirdre O’Keeffe, Lucy Butler, Suzanne Jolley

Published in: Trials | Issue 1/2018

Login to get access

Abstract

Background

Bipolar disorder is a chronic and disabling psychiatric condition, characterised by recurrent episodes of mania, hypomania and depression. It places a heavy burden on sufferers and families, with high societal and healthcare costs. Many service users with a diagnosis of bipolar disorder also experience prominent psychotic symptoms, with differential diagnoses of schizoaffective disorder, and relapses characterised by repeated manic psychotic episodes and grandiosity. Such presentations require specific adaptations to standard bipolar disorder interventions in order to address their psychosis, alongside mood regulation, with a particular emphasis on impulsivity, irritability, disinhibition and elation. The Balancing ACT study aims to evaluate an innovative group intervention combining Acceptance and Commitment Therapy and psychoeducation approaches (ACT/PE) with individuals experiencing bipolar disorder and/or symptoms within community psychosis services.

Methods

The Balancing ACT study is a randomised controlled trial comparing Balancing ACT groups (ACT/PE) plus routine care to routine care alone. Balancing ACT (ACT/PE) comprises ten group sessions, each lasting 2 hours, delivered weekly. The primary outcome is psychological wellbeing; secondary outcomes are mental health relapses (measured by service use averages for the 12 months pre baseline and 3 months post baseline). We will also measure mood, distress, recovery and psychological change processes. Participants will be randomised in a 1:1 ratio, after baseline assessment. Outcomes will be assessed by trained assessors blind to treatment condition at 0, 10 and 14 weeks. Recruitment began in April 2017 and is on-going until the end of October 2017.

Discussion

The Balancing ACT study will contribute to the currently limited evidence base for psychological interventions for people experiencing bipolar disorder and/or symptoms in the context of community psychosis services.

Trial registration

ISRCTN73327972. Registered on 27 March 2017. Balancing ACT: evaluating the effectiveness of psychoeducation and Acceptance and Commitment Therapy (ACT) groups for people with bipolar disorder.
Appendix
Available only for authorised users
Literature
1.
go back to reference Mansell W, Morrison AP, Reid G, Lowens I, Tai S. The interpretation of, and responses to, changes in internal states: an integrative cognitive model of mood swings and bipolar disorders. Behav Cogn Psychother. 2007;35(05):515–39. Mansell W, Morrison AP, Reid G, Lowens I, Tai S. The interpretation of, and responses to, changes in internal states: an integrative cognitive model of mood swings and bipolar disorders. Behav Cogn Psychother. 2007;35(05):515–39.
3.
go back to reference Mansell W, Tai S, Clark A, Akgonul S, Dunn G, Davies L, et al. A novel cognitive behaviour therapy for bipolar disorders (Think Effectively About Mood Swings or TEAMS): study protocol for a randomized controlled trial. Trials. 2014;15(1):405.CrossRefPubMedPubMedCentral Mansell W, Tai S, Clark A, Akgonul S, Dunn G, Davies L, et al. A novel cognitive behaviour therapy for bipolar disorders (Think Effectively About Mood Swings or TEAMS): study protocol for a randomized controlled trial. Trials. 2014;15(1):405.CrossRefPubMedPubMedCentral
4.
go back to reference Treuer T, Tohen M. Predicting the course and outcome of bipolar disorder: a review. Eur Psychiatry. 2010;25(6):328–33.CrossRefPubMed Treuer T, Tohen M. Predicting the course and outcome of bipolar disorder: a review. Eur Psychiatry. 2010;25(6):328–33.CrossRefPubMed
5.
go back to reference Gitlin MJ, Swendsen J, Heller TL, Hammen C. Relapse and impairment in bipolar disorder. Am J Psychiatry. 1995;152(11):1635.CrossRefPubMed Gitlin MJ, Swendsen J, Heller TL, Hammen C. Relapse and impairment in bipolar disorder. Am J Psychiatry. 1995;152(11):1635.CrossRefPubMed
6.
go back to reference Scott J, Colom F, Vieta E. A meta-analysis of relapse rates with adjunctive psychological therapies compared to usual psychiatric treatment for bipolar disorders. Int J Neuropsychopharmacol. 2007;10(01):123–9.CrossRefPubMed Scott J, Colom F, Vieta E. A meta-analysis of relapse rates with adjunctive psychological therapies compared to usual psychiatric treatment for bipolar disorders. Int J Neuropsychopharmacol. 2007;10(01):123–9.CrossRefPubMed
7.
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(5–6):71–577. 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(5–6):71–577.
8.
go back to reference Miklowitz DJ. Adjunctive psychotherapy for bipolar disorder: state of the evidence. Am J Psychiatr. 2008;165(11):1408–19.CrossRefPubMed Miklowitz DJ. Adjunctive psychotherapy for bipolar disorder: state of the evidence. Am J Psychiatr. 2008;165(11):1408–19.CrossRefPubMed
9.
go back to reference NICE. Schizophrenia: core interventions in the treatment and management of schizophrenia in adults in primary and secondary care, NICE clinical guideline; 2009. p. 82. NICE. Schizophrenia: core interventions in the treatment and management of schizophrenia in adults in primary and secondary care, NICE clinical guideline; 2009. p. 82.
10.
go back to reference Hayes SC, Strosahl K, Wilson KG. Acceptance and commitment therapy: an experiential approach to behavior change. New York: Guilford Press; 1999. Hayes SC, Strosahl K, Wilson KG. Acceptance and commitment therapy: an experiential approach to behavior change. New York: Guilford Press; 1999.
11.
go back to reference Öst LG. The efficacy of acceptance and commitment therapy: an updated systematic review and meta-analysis. Behav Res Ther. 2014;61:105–21.CrossRefPubMed Öst LG. The efficacy of acceptance and commitment therapy: an updated systematic review and meta-analysis. Behav Res Ther. 2014;61:105–21.CrossRefPubMed
12.
go back to reference Davis ML, Morina N, Powers MB, Smits JAJ, Emmelkamp PMG. A meta-analysis of the efficacy of acceptance and commitment therapy for clinically relevant mental and physical health problems. Psychother Psychosom. 2015;84(1):30–6.CrossRefPubMed Davis ML, Morina N, Powers MB, Smits JAJ, Emmelkamp PMG. A meta-analysis of the efficacy of acceptance and commitment therapy for clinically relevant mental and physical health problems. Psychother Psychosom. 2015;84(1):30–6.CrossRefPubMed
13.
go back to reference Bach P, Hayes SC. The use of acceptance and commitment therapy to prevent the rehospitalization of psychotic patients: a randomized controlled trial. J Consult Clin Psychol. 2002;70(5):1129.CrossRefPubMed Bach P, Hayes SC. The use of acceptance and commitment therapy to prevent the rehospitalization of psychotic patients: a randomized controlled trial. J Consult Clin Psychol. 2002;70(5):1129.CrossRefPubMed
14.
go back to reference Pankowski S, Adler M, Andersson G, Lindefors N, Svanborg C. Group acceptance and commitment therapy (ACT) for bipolar disorder and co-existing anxiety—an open pilot study. Cogn Behav Ther. 2017;46(2):114–28.CrossRefPubMed Pankowski S, Adler M, Andersson G, Lindefors N, Svanborg C. Group acceptance and commitment therapy (ACT) for bipolar disorder and co-existing anxiety—an open pilot study. Cogn Behav Ther. 2017;46(2):114–28.CrossRefPubMed
15.
go back to reference Gergel T, Owen GS. Fluctuating capacity and advance decision-making in bipolar affective disorder—self-binding directives and self-determination. Int J Law Psychiatry. 2015;40:92–101.CrossRefPubMedPubMedCentral Gergel T, Owen GS. Fluctuating capacity and advance decision-making in bipolar affective disorder—self-binding directives and self-determination. Int J Law Psychiatry. 2015;40:92–101.CrossRefPubMedPubMedCentral
16.
go back to reference Kurtz MM, Gerraty RT. A meta-analytic investigation of neurocognitive deficits in bipolar illness: profile and effects of clinical state. Neuropsychology. 2009;23(5):551.CrossRefPubMedPubMedCentral Kurtz MM, Gerraty RT. A meta-analytic investigation of neurocognitive deficits in bipolar illness: profile and effects of clinical state. Neuropsychology. 2009;23(5):551.CrossRefPubMedPubMedCentral
17.
go back to reference Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat. 2005;4(4):287–91.CrossRef Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat. 2005;4(4):287–91.CrossRef
18.
go back to reference Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012;65(3):301–8.CrossRefPubMed Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012;65(3):301–8.CrossRefPubMed
19.
go back to reference Beecham J, Knapp M. Costing psychiatric interventions. In: Measuring mental health needs. Thornicroft G, editor. London: Gaskell; 2001. p. 200–224.46. Beecham J, Knapp M. Costing psychiatric interventions. In: Measuring mental health needs. Thornicroft G, editor. London: Gaskell; 2001. p. 200–224.46.
20.
go back to reference Johns LC, Oliver JE, Khondoker M, Byrne M, Jolley S, Wykes T, et al. The feasibility and acceptability of a brief Acceptance and Commitment Therapy (ACT) group intervention for people with psychosis: the ‘ACT for life’ study. J Behav Ther Exp Psychiatry. 2016;50:257–63.CrossRefPubMed Johns LC, Oliver JE, Khondoker M, Byrne M, Jolley S, Wykes T, et al. The feasibility and acceptability of a brief Acceptance and Commitment Therapy (ACT) group intervention for people with psychosis: the ‘ACT for life’ study. J Behav Ther Exp Psychiatry. 2016;50:257–63.CrossRefPubMed
21.
go back to reference Michalak EE, Murray G. Development of the QoL. BD: a disorder-specific scale to assess quality of life in bipolar disorder. Bipolar Disord. 2010;12(7):727–40.CrossRefPubMed Michalak EE, Murray G. Development of the QoL. BD: a disorder-specific scale to assess quality of life in bipolar disorder. Bipolar Disord. 2010;12(7):727–40.CrossRefPubMed
22.
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(1):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(1):58–66.CrossRefPubMed
23.
go back to reference Xiao L, Gao Y, Zhang L, Chen P, Sun X, Tang S. Validity and reliability of the Brief version of Quality of Life in Bipolar Disorder (Brief QoL. BD) among Chinese bipolar patients. J Affect Disord. 2016;193:66–72.CrossRefPubMed Xiao L, Gao Y, Zhang L, Chen P, Sun X, Tang S. Validity and reliability of the Brief version of Quality of Life in Bipolar Disorder (Brief QoL. BD) among Chinese bipolar patients. J Affect Disord. 2016;193:66–72.CrossRefPubMed
24.
go back to reference Bauer M, Crits-Christoph P, Ball W, Dewees E, McAllister T, Alahi P, et al. Independent assessment of manic and depressive symptoms by self-rating: scale characteristics and implications for the study of mania. Arch Gen Psychiatry. 1991;48:807–12.CrossRefPubMed Bauer M, Crits-Christoph P, Ball W, Dewees E, McAllister T, Alahi P, et al. Independent assessment of manic and depressive symptoms by self-rating: scale characteristics and implications for the study of mania. Arch Gen Psychiatry. 1991;48:807–12.CrossRefPubMed
25.
go back to reference Barkham M, Bewick B, Mullin T, Gilbody S, Connell J, Cahill J, et al. The CORE-10: a short measure of psychological distress for routine use in the psychological therapies. Counsell Psychother Res J. 2013;13:3–13.CrossRef Barkham M, Bewick B, Mullin T, Gilbody S, Connell J, Cahill J, et al. The CORE-10: a short measure of psychological distress for routine use in the psychological therapies. Counsell Psychother Res J. 2013;13:3–13.CrossRef
26.
go back to reference Jones S, Mulligan LD, Higginson S, Dunn G, Morrison AP. The Bipolar Recovery Questionnaire: psychometric properties of a quantitative measure of recovery experiences in bipolar disorder. J Affect Disord. 2013;147(1):34–43.CrossRefPubMed Jones S, Mulligan LD, Higginson S, Dunn G, Morrison AP. The Bipolar Recovery Questionnaire: psychometric properties of a quantitative measure of recovery experiences in bipolar disorder. J Affect Disord. 2013;147(1):34–43.CrossRefPubMed
27.
go back to reference Smout M, Davies M, Burns N, Christie A. Development of the Valuing Questionnaire (VQ). J Contextual Behav Sci. 2014;3(3):164–72.CrossRef Smout M, Davies M, Burns N, Christie A. Development of the Valuing Questionnaire (VQ). J Contextual Behav Sci. 2014;3(3):164–72.CrossRef
28.
go back to reference Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, et al. Preliminary psychometric properties of the Acceptance and Action Questionnaire–II: A revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011;42(4):676–88.CrossRefPubMed Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, et al. Preliminary psychometric properties of the Acceptance and Action Questionnaire–II: A revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011;42(4):676–88.CrossRefPubMed
29.
go back to reference Chadwick P, Hember M, Symes J, Peters E, Kuipers E, Dagnan D. Responding mindfully to unpleasant thoughts and images: reliability and validity of the Southampton Mindfulness Questionnaire (SMQ). Br J Clin Psychol. 2008;47(4):451–5.CrossRefPubMed Chadwick P, Hember M, Symes J, Peters E, Kuipers E, Dagnan D. Responding mindfully to unpleasant thoughts and images: reliability and validity of the Southampton Mindfulness Questionnaire (SMQ). Br J Clin Psychol. 2008;47(4):451–5.CrossRefPubMed
31.
go back to reference Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.CrossRefPubMedPubMedCentral Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7.CrossRefPubMedPubMedCentral
32.
go back to reference Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRefPubMedPubMedCentral Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRefPubMedPubMedCentral
Metadata
Title
Balancing ACT: evaluating the effectiveness of psychoeducation and Acceptance and Commitment Therapy (ACT) groups for people with bipolar disorder: study protocol for pilot randomised controlled trial
Authors
Emma O’Donoghue
Abigail Clark
Matthew Richardson
John Hodsoll
Sunil Nandha
Eric Morris
Fergus Kane
Deirdre O’Keeffe
Lucy Butler
Suzanne Jolley
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2789-y

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue