Feasibility randomised controlled trial of Recovery-focused Cognitive Behavioural Therapy for Older Adults with bipolar disorder (RfCBT-OA): study protocol

• Published in: BMJ open 2016-03, Vol.6 (3), p.e010590-e010590
• Main Authors: Tyler, Elizabeth, Lobban, Fiona, Sutton, Chris, Depp, Colin, Johnson, Sheri, Laidlaw, Ken, Jones, Steven H
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Behavior modification; Bipolar disorder; Bipolar Disorder - therapy; Clinical outcomes; Cognitive Behavioral Therapy - methods; Consent; Cost analysis; Cost-Benefit Analysis; England; Feasibility Studies; Female; Health services; Humans; Intervention; Kaplan-Meier Estimate; Male; Mental Health; Older people; Proportional Hazards Models; Psychotherapy; Quality of Life; Quality-Adjusted Life Years; Research Design; Treatment Outcome
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2015-010590

IntroductionBipolar disorder is a severe and chronic mental health problem that persists into older adulthood. The number of people living with this condition is set to rise as the UK experiences a rapid ageing of its population. To date, there has been very little research or service development with respect to psychological therapies for this group of people.Methods and analysisA parallel two-arm randomised controlled trial comparing a 14-session, 6-month Recovery-focused Cognitive-Behavioural Therapy for Older Adults with bipolar disorder (RfCBT-OA) plus treatment as usual (TAU) versus TAU alone. Participants will be recruited in the North-West of England via primary and secondary mental health services and through self-referral. The primary objective of the study is to evaluate the feasibility and acceptability of RfCBT-OA; therefore, a formal power calculation is not appropriate. It has been estimated that randomising 25 participants per group will be sufficient to be able to reliably determine the primary feasibility outcomes (eg, recruitment and retention rates), in line with recommendations for sample sizes for feasibility/pilot trials. Participants in both arms will complete assessments at baseline and then every 3 months, over the 12-month follow-up period. We will gain an estimate of the likely effect size of RfCBT-OA on a range of clinical outcomes and estimate parameters needed to determine the appropriate sample size for a definitive, larger trial to evaluate the effectiveness and cost-effectiveness of RfCBT-OA. Data analysis is discussed further in the Analysis section in the main paper.Ethics and disseminationThis protocol was approved by the UK National Health Service (NHS) Ethics Committee process (REC ref: 15/NW/0330). The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and local, participating NHS trusts.Trial registration numberISRCTN13875321; Pre-results.