RUFUS - Group Rumination-focused CBT for Negative Symptoms (RUFUS)

• ClinicalTrials.gov Identifier: NCT05851950
• Recruitment Status: Recruiting
• First Posted: May 10, 2023
• Last Update Posted: October 23, 2023
• Sponsor: Mental Health Services in the Capital Region, Denmark
• Information provided by (Responsible Party): Mental Health Services in the Capital Region, Denmark

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Psychotic Disorders	Other: group rumination focused cognitive behavioural therapy; Other: Treatment as usual	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: August 1, 2023
• Estimated Primary Completion Date: January 31, 2025
• Estimated Study Completion Date: July 1, 2026

Arms and Interventions

Arm	Intervention/treatment
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; Psychotherapy
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; opus treatment

Outcome Measures

Primary Outcome Measures :

1. the Brief Negative Symptoms Scale (BNSS) [ Time Frame: up to 20 weeks ]
   Assessment of negative symptoms on a scale from 0-78

Secondary Outcome Measures :

1. Perseverative Thinking Questionnaire (PTQ) [ Time Frame: up to 20 weeks ]
   Measuring frequency of rumination. Resulting in a total score of 0-60.
2. 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.
3. Social Functioning Scale (SFS) [ Time Frame: up to 20 weeks ]
   Measuring level of functioning on a scale from of 0-228
4. 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
5. Calgary depression scale (CDS) [ Time Frame: up to 20 weeks ]
   Measuring depressive symptoms on a scale from 0-27
6. Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: up to 20 weeks ]
   Measuring executive functioning on a scale from 75-225

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 37 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Contacts

Contact: Lars Clemmensen; 23492490; lars.clemmensen@regionh.dk

Locations

Denmark

Mental Health Centre Copenhagen; Recruiting

Copenhagen, Denmark

Contact: Christin Lund christin.louise.nymann.lund@regionh.dk

Sponsors and Collaborators

Mental Health Services in the Capital Region, Denmark

Investigators

• Principal Investigator: Louise B Glenthøj; Mental health center of Copenhagen

More Information

• Responsible Party: Mental Health Services in the Capital Region, Denmark
• ClinicalTrials.gov Identifier: NCT05851950
• Other Study ID Numbers: 05851950
• First Posted: May 10, 2023
• Last Update Posted: October 23, 2023
• Last Verified: October 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders