REWRITALIZE Your Recovery - Evaluation of a Creative Writing Group Intervention

NCT06251908 | Active Not Recruiting

• 1 other identifier: p-2023-14655
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 6

Brief Summary

Health institutes call for psychosocial interventions and recovery-oriented approaches as supplement to pharmacological treatment for mental health disorders. Participatory art interventions have been suggested to be promising in promoting recovery by stimulating connectedness, hope, renegotiation of identity, participatory meaning-making and empowerment. Moreover, cognitive literature studies suggest there might be potential benefits of engaging with literature in terms of improved cognition and social cognition. In spite of promising findings, the evidence base is still thin. We have developed REWRITALIZE (REWR), a manualised, recovery-oriented fifteen-session participatory creative writing group intervention, led by a professional author and attended by a mental health professional. The intervention comprises introduction to literary forms, spontaneous writing on those forms, sharing texts and engaging in reflective discussions about them. It is designed to provide a holding and non-stigmatising environment. The aim of the present study is to evaluate REWR for persons with severe mental illness. This study is a randomised controlled clinical trial (RCT) with an embedded pilot RCT focusing on clinical and personal recovery. This study is an investigator-initiated, randomised, two-arm, single-blinded, multi-center, waiting list trial. Participants (n=266) with severe mental illness (\>18 yrs.) will be recruited at six psychiatric centres in region Zealand and randomised to active (creative writing group + treatment as usual) or control (waiting list + treatment as usual) condition. Assessments will be collected pre- and post-intervention and six months after end of intervention. The primary outcome measure will be the questionnaire of the process of recovery administered at the end of the intervention. Secondary outcome measures comprise measures of recovery, self-efficacy and mentalising assessed at the end of the intervention and six months after the intervention ends. The post-intervention measures will be compared between active and control groups by means of independent sample t-tests. The pilot RCT will focus on a subset of participants (n=70) with schizophrenia spectrum disorders (18-35 yrs), evaluating exploratory outcome measures related perspective-taking, social cognition, cognitive function, psychosocial functioning, and symptom level.

Conditions

Severe Depression; Personality Disorder, Borderline; Psychosis; Schizophreniform Disorders; Bipolar Disorder; Ptsd

Keywords

recovery; creative writing groups; pilot RCT; schizophrenia spectrum disorders; participatory arts

Outcome Measures

Primary Outcomes (1)

• Questionnaire for the process of recovery (QPR)

  Measure of overall personal recovery. Total score range: 0-60. High is better.

  Measured at baseline and immediately after the end of intervention (4.5 months after baseline)

Secondary Outcomes (7)

• Questionnaire for the process of recovery (QPR)

  Measured at baseline and six months after the end of intervention (10.5 months after baseline)

• Thwarted Belongingness Scale (TBS)

  Measured at baseline and immediately after the end of intervention (4.5 months after baseline)

• Self efficacy for personal recovery (SEPRS)

  Measured at baseline and immediately after the end of intervention (4.5 months after baseline)

• Mentalization scale (MentS)

  Measured at baseline and immediately after the end of intervention (4.5 months after baseline)

• Toronto Alexithymia scale (TAS)

  Measured at baseline and immediately after the end of intervention (4.5 months after baseline)

Other Outcomes (11)

• Exploratory: Thwarted Belongingness Scale (TBS)

  Measured at baseline and six months after the end of intervention (10.5 months after baseline)

• Exploratory: Self efficacy for personal recovery (SEPRS)

  Measured at baseline and six months after the end of intervention (10.5 months after baseline)

• Exploratory: Mentalization scale (MentS)

  Measured at baseline and six months after the end of intervention (10.5 months after baseline)

Study Arms (2)

Active intervention arm

EXPERIMENTAL

Participants allocated to active intervention arm will receive Rewritalize in addition to standard mental health care

Other: Rewritalize; Other: Standard mental health care

Control arm

ACTIVE COMPARATOR

Participants allocated to the control arm will receive standard mental health care.

Other: Standard mental health care

Interventions

Rewritalize OTHER

REWR is conceptualised as a hybrid between an art group and a group therapy intervention. It is structured as a progressive participatory art group program led by a conductor-tandem: the primary conductor, a professional writer with extensive teaching experience, is supplemented by a co-conductor with clinical expertise who participates in the group activities together with the other participants. The conductor-tandem secure high artistic standards while also ensuring psychological safety. A close collaboration between the two is necessary and both participate in a 30-hour preparatory course and are supervised during the course of the intervention. The writing course consists in 15 sessions of 3 hours per session. At each session participants are introduced to literary texts that work as prompts for the writing exercises, which last 5-15 min. After each text is read out loud, the participants engage in a reflective discussion about the text.

Also known as: REWR

Active intervention arm

Standard mental health care OTHER

F-ACT is a community-based treatment model that provides multidisciplinary, flexible, and assertive outpatient treatment to patients with severe mental illness. OPUS is a nationally implemented 2-year-long early intervention for people with first-episode psychosis. OPUS is a multidisciplinary assertive community treatment model and offer psychoeducation, social skills training, relapse prevention and family involvement, including possibility for treatment participation in psychoeducational multifamily groups. In F-ACT and OPUS a primary staff member is in regular contact with the patient and responsible for coordinating the treatment elements. The treatment is individual and contingent upon patients' needs.

Also known as: Flexible assertive community treatment (F-ACT) and early intervention (OPUS)

Active intervention arm; Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a severe mental illness
• Minimum 18 yrs. of age
• Master Danish

You may not qualify if:

• Aggressive or disruptive behaviour that hinders participation

Sponsors & Collaborators

• Amager Hospital: lead

Study Sites (6)

Psychiatric Centre Bornholm

Rønne, Bornholm, 3700, Denmark

Location

Psychiatric Centre Nørrebro

Copenhagen, Region Sjælland, 2100, Denmark

Location

Psychiatric centre Amager

Copenhagen, Region Sjælland, 2300, Denmark

Location

Psychiatric Centre North

Hillerød, Region Sjælland, 3400, Denmark

Location

Psychiatric Centre West

Holbæk, Region Sjælland, 4300, Denmark

Location

Psychiatric Centre South

Vordingborg, Region Sjælland, 4760, Denmark

Location

Related Publications (1)

• Henningsson S, Brestisson JT, Bjorkedal SB, Bundesen B, Nielsen KS, Ebersbach B, Hjorthoj C, Eplov LF. 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. BMC Psychiatry. 2024 Dec 5;24(1):891. doi: 10.1186/s12888-024-06254-5.

  PMID: 39639282 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Bipolar Disorder; Depression; Stress Disorders, Post-Traumatic; Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Personality Disorders

Study Officials

• Lene F Eplov, Dr.

  Mental Health Services Capital Region Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Owing to the nature of the intervention, neither participants nor staff can be blinded to allocation. They will be instructed not to disclose the allocation status to the researchers. Baseline data will be collected prior to randomisation and the research clinicians and research assistant that collect follow-up data will be blinded. If he or she is unblinded during the follow-up assessments, for instance if the participant accidentally reveals his or her allocation status, the participant will be invited to another follow-up session, with a blinded assessor. An employee outside the research team will extract data from REDCap on study completion and group allocation will be coded with A and B to ensure blinding of the researchers while analysing data, interpretation of data, drawing conclusions, and writing up reports.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research, Associate professor

Model Details: The RCT is designed as an investigator-initiated, randomised, two-arm, single-blinded, multi-center, waiting list-controlled superiority trial, with an embedded pilot RCT.

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 9, 2024
• Study Start: February 12, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (6)