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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psychotic Disorders
• Intervention / Treatment: Other: group rumination focused cognitive behavioural therapy; Other: Treatment as usual

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lars Clemmensen; Phone Number: 23492490; Email: lars.clemmensen@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • Mental Health Centre Copenhagen
    • Contact: Christin Lund; Email: christin.louise.nymann.lund@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Brief Negative Symptoms Scale (BNSS)	Assessment of negative symptoms on a scale from 0-78	up to 20 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Investigators: Principal Investigator: Louise B Glenthøj, Mental health center of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders
• Other Study ID Numbers: 05851950

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No