RUFUS - Group Rumination-focused CBT for Negative Symptoms

Not Applicable

Recruiting

• Conditions: Psychotic Disorders
• Interventions: Other: group rumination focused cognitive behavioural therapy; Other: Treatment as usual

• Registration Number: NCT05851950
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-01
• Study First Submitted QC: 2023-05-01
• Study First Posted: 2023-05-10
• Study Start: 2023-08-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-23
• Primary Completion: 2025-01-31
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rumination-focused cognitive behavioural group therapy	group rumination focused cognitive behavioural therapy	1 individual in-take session, 11 sessions of rumination-focused cognitive behavioural group therapy, 1 individual closing session.
Treatment as usual	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mental Health Centre Copenhagen; 🇩🇰 Copenhagen, Denmark