RUFUS - Group Rumination-focused CBT for Negative Symptoms (RUFUS)
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|ClinicalTrials.gov Identifier: NCT05851950
Recruitment Status : Recruiting
First Posted : May 10, 2023
Last Update Posted : October 23, 2023
Abstract - --
Psychosis spectrum disorders are characterized by both positive and negative symptoms, but whereas there is good effect of treatment on positive symptoms, there is still a scarcity of effective interventions aimed at reducing negative symptoms. Rumination has been proposed as an important and fundamental factor in the development and maintenance of symptoms across psychiatric diagnoses, and there is a need to develop effective interventions targeting rumination behaviors and negative symptoms in patients with psychotic disorders. The aim of the current study is to investigate the feasibility and acceptability of group rumination-focused cognitive behavioral therapy (RFCBT) in the treatment of young people with psychosis spectrum disorders as well as investigating potential indications of treatment efficacy.
Methods and analysis: The study is a mixed-method clinical randomized controlled pilot trial with a target sample of 60 patients, who are randomized to either receive 13 weeks of group CFCBT or 13 weeks of treatment as usual (TAU). All patients are examined at the start of the project and at the 13-week follow-up. The researcher will compare changes in outcomes from baseline to posttreatment between group CFCBT and TAU. In addition, qualitative analyzes are carried out to explore feasibility and acceptability and to uncover the patients' experience of receiving the intervention.
|Condition or disease
|Other: group rumination focused cognitive behavioural therapy Other: Treatment as usual
|Study Type :
|Interventional (Clinical Trial)
|Estimated Enrollment :
|Single (Outcomes Assessor)
|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
|Actual Study Start Date :
|August 1, 2023
|Estimated Primary Completion Date :
|January 31, 2025
|Estimated Study Completion Date :
|July 1, 2026
Experimental: rumination-focused cognitive behavioural group therapy
1 individual in-take session, 11 sessions of rumination-focused cognitive behavioural group therapy, 1 individual closing session.
Other: group rumination focused cognitive behavioural therapy
Active Comparator: Treatment as usual
standard OPUS treatment. OPUS treatment is handled by an interdisciplinary OPUS team and consists primarily of medical treatment, psychoeducation, training in symptom management and social skills as well as family discussions. All patients in OPUS have a contact doctor and a contact person who is responsible for coordinating the treatment and collaborating with municipal bodies.
Other: Treatment as usual
- the Brief Negative Symptoms Scale (BNSS) [ Time Frame: up to 20 weeks ]Assessment of negative symptoms on a scale from 0-78
- Perseverative Thinking Questionnaire (PTQ) [ Time Frame: up to 20 weeks ]Measuring frequency of rumination. Resulting in a total score of 0-60.
- Ruminative Response Scale (RRS) [ Time Frame: up to 20 weeks ]Measuring levels of rumination in relation to depression. Resulting in a total score of 22-88.
- Social Functioning Scale (SFS) [ Time Frame: up to 20 weeks ]Measuring level of functioning on a scale from of 0-228
- Scale for the assessment of positive symptoms (SAPS) [ Time Frame: up to 20 weeks ]Measuring presence of positive symptoms on a scale from 0-170
- Calgary depression scale (CDS) [ Time Frame: up to 20 weeks ]Measuring depressive symptoms on a scale from 0-27
- Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: up to 20 weeks ]Measuring executive functioning on a scale from 75-225
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05851950
|Contact: Lars Clemmensen
|Mental Health Centre Copenhagen
|Contact: Christin Lund email@example.com
|Louise B Glenthøj
|Mental health center of Copenhagen