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Clinical effectiveness and cost-effectiveness of Structured Psychological Support for people with probable personality disorder in mental health services in England: study protocol for a randomised controlled trial

Crawford, M. J., Leeson, V. C., Evans, R. , Goulden, N., Weaver, T., Trumm, A., Barrett, B. M., Khun-Thompson, F., Pandya, S. P., Saunders, K. E., Lamph, G., Woods, D., Smith, H., Greenall, T., Nicklin, V. & Barnicot, K. ORCID: 0000-0001-5083-5135 (2024). Clinical effectiveness and cost-effectiveness of Structured Psychological Support for people with probable personality disorder in mental health services in England: study protocol for a randomised controlled trial. BMJ Open, 14(6), article number e086593. doi: 10.1136/bmjopen-2024-086593

Abstract

Introduction
Evidence-based psychological treatments for people with personality disorder usually involve attending group-based sessions over many months. Low-intensity psychological interventions of less than 6 months duration have been developed, but their clinical effectiveness and cost-effectiveness are unclear.

Methods and analysis
This is a multicentre, randomised, parallel-group, researcher-masked, superiority trial. Study participants will be aged 18 and over, have probable personality disorder and be treated by mental health staff in seven centres in England. We will exclude people who are: unwilling or unable to provide written informed consent, have a coexisting organic or psychotic mental disorder, or are already receiving psychological treatment for personality disorder or on a waiting list for such treatment. In the intervention group, participants will be offered up to 10 individual sessions of Structured Psychological Support. In the control group, participants will be offered treatment as usual plus a single session of personalised crisis planning. The primary outcome is social functioning measured over 12 months using total score on the Work and Social Adjustment Scale (WSAS). Secondary outcomes include mental health, suicidal behaviour, health-related quality of life, patient-rated global improvement and satisfaction, and resource use and costs. The primary analysis will compare WSAS scores across the 12-month period using a general linear mixed model adjusting for baseline scores, allocation group and study centre on an intention-to-treat basis. In a parallel process evaluation, we will analyse qualitative data from interviews with study participants, clinical staff and researchers to examine mechanisms of impact and contextual factors.

Ethics and dissemination
The study complies with the Helsinki Declaration II and is approved by the London—Bromley Research Ethics Committee (IRAS ID 315951). Study findings will be published in an open access peer-reviewed journal; and disseminated at national and international conferences.

Publication Type: Article
Additional Information: © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:Â http://creativecommons.org/licenses/by-nc/4.0/.
Publisher Keywords: Humans, Treatment Outcome, Personality Disorders, Mental Health Services, Quality of Life, Adult, Cost-Benefit Analysis, England, Multicenter Studies as Topic, Psychosocial Intervention, MENTAL HEALTH, Personality disorders, Psychosocial Intervention, Randomized Controlled Trial, Humans, Cost-Benefit Analysis, England, Mental Health Services, Personality Disorders, Quality of Life, Treatment Outcome, Multicenter Studies as Topic, Adult, Psychosocial Intervention, 1103 Clinical Sciences, 1117 Public Health and Health Services, 1199 Other Medical and Health Sciences, 32 Biomedical and clinical sciences, 42 Health sciences, 52 Psychology
Subjects: B Philosophy. Psychology. Religion > BF Psychology
R Medicine > RC Internal medicine > RC0321 Neuroscience. Biological psychiatry. Neuropsychiatry
Departments: School of Health & Psychological Sciences
School of Health & Psychological Sciences > Healthcare Services Research & Management
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