Group therapy focusing on rumination for young people with psychotic disorders
RUFUS - a Randomized Mixed Methods Pilot Clinical Trial Investigating the Relevance and Feasibility of Rumination-focused Cognitive Behavioral Therapy in the Treatment of Patients With Emergent Psychosis Spectrum Disorder
This study is testing a new group therapy designed to help young people with psychotic disorders by focusing on their negative thoughts to see if it works better than standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 37 Years |
| Sex | All |
| Sponsor | Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05851950 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and acceptability of group rumination-focused cognitive behavioral therapy (RFCBT) for young individuals diagnosed with psychosis spectrum disorders. It aims to address the negative symptoms associated with these disorders, which are often resistant to traditional treatments. The study will involve a randomized controlled pilot trial with 60 participants, assessing the impact of RFCBT compared to standard treatment. The effectiveness of this intervention will be evaluated through various measures, including the Perseverative Thinking Questionnaire.
Who should consider this trial
Good fit: Ideal candidates are Danish-speaking young individuals diagnosed with a psychosis spectrum disorder who exhibit rumination behaviors.
Not a fit: Patients with severe suicidal thoughts, substance abuse issues, or those lacking the capacity to consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce negative symptoms in young patients with psychotic disorders, improving their overall quality of life.
How similar studies have performed: While there is limited research specifically on RFCBT for psychotic disorders, similar cognitive behavioral approaches have shown promise in addressing negative symptoms in other psychiatric conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosed with a psychosis spectrum disorder (ICD-10 F2x) 2. At least 8 months left of their OPUS treatment 3. The presence of rumination behavior as assessed by a score of minimum 30 on the Perseverative Thinking Questionnaire (PTQ) 4. Danish-speaking Exclusion Criteria: 1. Substance abuse or positive symptoms that make participation in therapy difficult 2. Severe suicidal thoughts/behavior 3. Lacks capacity to consent 4. Mild, moderate, or severe intellectual disability (IQ ˂ 70) 5. Planned adjustment of antidepressant and/or antipsychotic treatment (noted in the patient's medical record)
Where this trial is running
Copenhagen
- Mental Health Centre Copenhagen — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Louise B Glenthøj — Mental health center of Copenhagen
- Study coordinator: Lars Clemmensen
- Email: lars.clemmensen@regionh.dk
- Phone: 23492490
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.