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Abstract
Introduction Improving accessible, acceptable recovery-oriented service provision for people with bipolar disorder (BD) is an important priority. Mindfulness and acceptance-based cognitive and behavioural therapies (or ‘third -wave’ CBT) may prove fruitful due to the considerable overlap between these approaches and key features of personal recovery. Groups also confer therapeutic benefits consistent with personal recovery and may improve recovery-oriented service provision by adding another modality for accessing support. The primary objective of this trial is to explore the feasibility and acceptability of a new recovery-focused group therapy (RfGT) intervention for adults with BD. This is the first published feasibility assessment of a time-limited RfGTrecovery-focused group therapy intervention for BD.
Methods/ analysis This protocol describes an open feasibility study, utilising a pre-treatment design versus post- treatment design and nested qualitative evaluation. Participants will be recruited from the Central Coast region of New South Wales, Australia, from primary care providers, specialist mental health services, non-government organisations and via self-referral. The primary outcomes are feasibility and acceptability as indexed by recruitment, retention, intervention adherence, adverse events (if any) and detailed consumer feedback. Clinical outcomes and process measures will be assessed to inform future research. Primary outcome data will utiliseuse descriptive statistics (eg, summarizingsummarising recruitment, demographics, attendance, attrition and intervention adherence). Secondary outcomes will be assessed using repeated-measures analysis of covariance across all time points (including change, effect size and variability).
Ethics and dissemination Ethical approval has been granted by the Northern Sydney Local Health District HREChuman research ethics committee (HREC) (HREC/16/HAWKE/69) and The University of Newcastle HREC (H-2016–0107). The Ffindings will be used to improve the intervention per user needs and preferences, and inform what amendments and/or information are required before a follow-on trial would be possible. This study contributes to a growing body of innovative, recovery-oriented innovations of psychological treatments for adults with BD.
Trial registration number ACTRN12616000887471; Pre-results.
- bipolar disorder
- recovery
- group therapy
- psychological intervention
- third wave cbt
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Footnotes
Contributors AKB is a trial coordinator and led the development of the study protocol, recovery-focused group therapy intervention and manuscript in collaboration with all investigators listed. All investigators contributed to study design, selection of assessment instruments and informing the duration and content of the group therapy intervention. Specifically, ALB contributed expertise on motivational interviewing and multiple health behaviour change; SHJ contributed expertise on recovery focused interventions in bipolar disorder (BD); FL contributed expertise on the conduct and process of group therapy interventions in BD; FK-L contributed expertise on cognitive behaviour therapy for severe mental illness and potential opportunities for integrating technology (eg, self-monitoring); MB provided expertise from the perspective of a person with lived experience of BD (including co-facilitating focus groups with AKB)—ensuring that the perspective of the service user was represented throughout all stages of the research process. JA led the statistical analysis plan and contributed to study design (eg, advising on sample size and outcome measures). In summary, all authors made substantial contributions to study conception and design. All authors also offered critical revisions to the manuscript for important intellectual content, have approved the final version of this manuscript and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding Dr Beck is supported by a stipend from the NHMRC Centre for Research Excellence in Mental Health and Substance Use (APP1041129; G1200943). In-kind support (therapy room) is provided by the R.E.A.D. Clinic. Dr Banfield is supported by Australian Research Council Discovery Early Career Researcher Award DE150100637.
Competing interests We have read and understood BMJ policy on declaration of interests and declare the following interests: AKB is the CI and will be responsible for conducting the baseline assessments and group therapy intervention. She is also a contract clinical psychologist at the R.E.A.D. Clinic Erina, where the research is to be conducted. Nathan Beehag (co-facilitator) is a contract psychologist at the R.E.A.D. Clinic. The nature of the study minimises the likelihood of potential conflict of interest, in that study participation involves routine elements of psychological assessment (completion of self-report questionnaires, clinician-administered questionnaires and clinical interview) and participation does not require participants to change their current involvement with services.
Patient consent Obtained.
Ethics approval This study has been approved by the Northern Sydney Local Health District human research ethics committee, reference number RESP/16/45; HREC/16/HAWKE/69 and The University of Newcastle HREC, reference number H-2016-0107.
Provenance and peer review Not commissioned; externally peer reviewed.