RUFUS - Group Rumination-focused CBT for Negative Symptoms

Psychotic Disorders Clinical Trial

— RUFUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05851950
• Other study ID #: 05851950
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: July 1, 2026

Study information

• Verified date: October 2023
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: Lars Clemmensen
• Phone: 23492490
• Email: lars.clemmensen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Abstract - --

Introduction:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2026
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 37 Years

Eligibility

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)

Related Conditions & MeSH terms

• Psychotic Disorders

Intervention

Other:
• group rumination focused cognitive behavioural therapy
Psychotherapy
• Treatment as usual
opus treatment

Locations

Country	Name	City	State
Denmark	Mental Health Centre Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Brief Negative Symptoms Scale (BNSS)	Assessment of negative symptoms on a scale from 0-78	up to 20 weeks
Secondary	Perseverative Thinking Questionnaire (PTQ)	Measuring frequency of rumination. Resulting in a total score of 0-60.	up to 20 weeks
Secondary	Ruminative Response Scale (RRS)	Measuring levels of rumination in relation to depression. Resulting in a total score of 22-88.	up to 20 weeks
Secondary	Social Functioning Scale (SFS)	Measuring level of functioning on a scale from of 0-228	up to 20 weeks
Secondary	Scale for the assessment of positive symptoms (SAPS)	Measuring presence of positive symptoms on a scale from 0-170	up to 20 weeks
Secondary	Calgary depression scale (CDS)	Measuring depressive symptoms on a scale from 0-27	up to 20 weeks
Secondary	Behavior Rating Inventory of Executive Function (BRIEF)	Measuring executive functioning on a scale from 75-225	up to 20 weeks