Clinical Research Directory

REWRITALIZE Your Recovery - Evaluation of a Creative Writing Group Intervention

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.

At-Home tDCS as Maintenance Therapy

The primary purpuse of this pilot study is to find out whether a home-based transcranial direct current stimulation (tDCS) program is feasible and well tolerated as maintenance therapy and whether there are early signs that it helps maintain the clinical clinical benefits achieved during successful acute inpatient treatment. Participant population: Adults (18+) with depressive disorder who had already improved/stabilized after acute treatment at our clinic (esketamine, repetitive transcranial magnetic stimulation , or electroconvulsive therapy). Main questions: Feasibility: Do participants reliably complete the home program and stay in the study? Preliminary effectiveness: Do improvements of depressive symptoms hold up over the 4-week treatment and 2-week follow-up (based on self-report and clinician-rated scales)? Participants receive standardized instruction from trained staff and a portable tDCS device (with cap and small sponge electrodes) and complete 20 home sessions over 4 weeks (5 per week), each 30 minutes at a very low current (2 mA); the device gently ramps current up/down for comfort. During treatment, participants use a smartphone app with step-by-step guidance and reminders; sessions are automatically logged. They will also fill out short weekly self-rating questionnaires and join brief phone check-ins every 2 weeks. Where: Department and Outpatient Clinic of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technical University of Munich Safety \& data privacy: The device monitors electrode contact and pauses automatically if contact is poor. Typical sensations can include mild tingling or redness. The app stores anonymized session data so the care team can track progress; no personal data are exchanged between the app and the stimulator, and access is via a secure clinical portal.

Neuromodulation of Different Doses to Treat TRD Guided by pBFS Technique

The aim of this study is to explore the effectiveness and safety of different doses of neural regulation under the guidance of pBFS technology in improving symptoms in patients with moderate to severe depressive disorders.

Nebulized Ketamine for the Treatment of Major Depressive Disorder in an Inpatient Setting

This is a double blind active placebo controlled clinical trial for individuals within an inpatient setting with moderate to severe depression. The purpose of this study is to assess if nebulized ketamine can reduce depressive symptoms.