1. REWRITALIZE your recovery: a study protocol for a randomised controlled trial (RCT) examining the effectiveness of the new recovery-oriented creative writing group intervention REWRITALIZE for people with severe mental illness.
- Author
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Henningsson S, Brestisson JT, Bjørkedal SB, Bundesen B, Nielsen KS, Ebersbach B, Hjorthøj C, and Eplov LF
- Subjects
- Adult, Humans, Psychotherapy, Group methods, Randomized Controlled Trials as Topic, Creativity, Mental Disorders therapy, Mental Disorders psychology, Writing
- Abstract
Background: Health institutions advocate for psychosocial and recovery-oriented interventions alongside pharmacological treatment for severe mental illness. Participatory arts interventions appear promising in promoting personal recovery by fostering connectedness, hope, renegotiation of identity, meaning-making, and empowerment. Despite encouraging findings, however, the evidence base remains thin. Further, results from cognitive literature studies suggest possible impact on parameters of clinical recovery, but this has not been studied in clinical contexts. We developed REWRITALIZE, a structured, recovery-oriented, fifteen-session creative writing group intervention led by a professional author alongside a mental health professional. Participants engage with literary forms, write on them, share their texts, and partake in reflective discussions within a supportive, non-stigmatising environment, designed to promote self-expression, playful experimentation, agency, recognition, participatory meaning-making, renegotiation of identity and social engagement. The aim of this project is to evaluate REWRITALIZE for persons with severe mental illness through a randomised controlled trial (RCT) focusing on personal recovery outcomes. Additionally, an embedded pilot RCT will explore additional outcomes i.e., clinical recovery for a subgroup with schizophrenia spectrum disorders., Methods: The RCT is an investigator-initiated, randomised, two-arm, assessor-blinded, multi-center, waiting-list superiority trial involving 300 participants (age > 18) from six psychiatric centers in regions Capital and Zealand in Denmark, randomised to receive either the creative writing intervention combined with standard treatment or standard treatment alone. Assessments will be conducted before and after the intervention and at six months post intervention. The primary outcome is personal recovery at the end of intervention measured with the questionnaire of the process of recovery. Secondary outcomes include other measures of personal recovery, self-efficacy, mentalising, and quality of life. The pilot RCT, integrated within the RCT, will focus on 70 of the participants aged 18-35 with schizophrenia spectrum disorders, evaluating exploratory measures related to perspective-taking, social cognition, cognitive function, psychosocial functioning, and symptom pressure., Discussion: This is the first RCT for creative writing groups. It assesses whether REWRITALIZE, as adjunct to standard mental healthcare, is more effective for personal recovery than standard care. If successful, it would provide evidence for the efficacy of REWRITALIZE, potentially enabling its implementation across mental health centers in Denmark., Trial Registration: Privacy (data protection agency): p-2023-14655. Danish National Center for Ethics: 2313949., Clinicaltrials: gov: NCT06251908. Registration date 02.02.2024., Competing Interests: Declarations. Ethics approval and consent to participate: Information about the study is presented to all potential participants both verbally and in written form. At the information meeting and in the informed consent form it is made clear that the intervention is voluntary and safe, and that participants can stop their participation in the project at any time and withdraw their consent without consequences for the treatment they receive. If the participants wish to withdraw from the experiment during the intervention, there are three options: 1) They withdraw from the intervention but not from the study, therefore they will participate in the data collection at the follow-ups. 2) They withdraw from both the intervention and the study, but data from the baseline measures can be used in the research project. 3) They withdraw from both the intervention and the study, and their data will be deleted. The study will be conducted in agreement with the Declaration of Helsinki [116]. The Regional Ethical Committee for the Capital Region has decided that the study is not required to seek approval under their legislation (2313949), which covers human participation in medical trials. We will adhere to all other ethical standards guiding good practice in research. The study has been registered with the Danish Data Protection Agency (p-2023–14655), and we will comply with data security and GDPR regulations. The study has been registered at clinicaltrials.gov (NCT06251908), registration date 02.02.2024. If any modifications are made to the data collection or data analyses, these protocol amendments will be reported to the Danish Data Protection Agency and to clinicaltrials.gov. The intervention is not expected to have any serious side-effects. This is supported by the pilot study and similar studies [64]. Consent for publication: N/a. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)
- Published
- 2024
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