A Randomised Controlled Trial Examining the Effectiveness of the New Recovery-oriented Creative Writing Group Intervention REWRITALIZE for People With Schizophrenia Spectrum Disorders

Objective: The study has three objectives. The primary objective is to determine if REWR in addition to standard mental healthcare is more effective than standard mental healthcare alone for promoting personal recovery. The secondary objective is to investigate if REWR in addition to standard mental healthcare is more effective than standard mental healthcare alone in promoting a. mentalising, b. self-efficacy, c. functioning and quality of life. The third objective is to explore if REWR in addition to standard mental healthcare furthers clinical recovery, namely cognition, social cognition, psychosocial functioning, and symptom reduction in a sample of young people with schizophrenia spectrum disorders.

Hypotheses: The main hypothesis is that people living with a schizophrenia spectrum disorder who participate in REWR as an add-on to standard mental healthcare, as compared to those that receive standard mental healthcare alone, will show a greater improvement in personal recovery, measured by the Questionnaire for the process of recovery (QPR) immediately after the end of the intervention (approximately 4.5 months post-baseline). Secondary hypotheses include that those who receive REWR in addition to standard mental healthcare will show a greater improvement in personal recovery, as well as mentalising, self-efficacy, clinical recovery and wellbeing immediately after the end of the intervention (approximately 4.5 months post-baseline), as well as six months later (approximately 10.5 months post-baseline).

Ethical considerations: Information about the studies is presented to all potential participants both verbally and in written form so they can make an informed decision about their participation before signing the informed consent forms. Research assistants will make clear to the candidates that participation is voluntary, and that withdrawal can occur at any time without consequence for treatment possibilities. Decisions regarding participation will not influence clinical care in any way. At the information meeting and in the informed consent form it will thus be made clear that the intervention is voluntary and safe, and that participants at any time can stop their participation in the project and withdraw their consent without any consequences for the standard treatment they receive. If the participants wish to withdraw from the experiment during the course, 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. The Regional ethical committee for the Capital Region has decided that the study is not required to seek approval under their legislation, 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 all regulations regarding data security, and make sure that all technical solutions comply with GDPR regulations. The study will be registered at clinicaltrials.gov. 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. The social setting can be associated with anxiety and discomfort, at least initially, as known from previous group start-ups. A mental health care professional will always be present in the group (the co-conductor, see REWRITALIZE under Interventions) and this is expected to reduce participants' distress and to regulate reactions including crisis following the group activity. Supportive sessions are offered by the co-conductor if needed.