RUFUS - Group Rumination-focused CBT for Negative Symptoms

NCT05851950 | Recruiting DMC

• 1 other identifier: 05851950
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorders

Outcome Measures

Primary Outcomes (1)

• the Brief Negative Symptoms Scale (BNSS)

  Assessment of negative symptoms on a scale from 0-78

  up to 20 weeks

Secondary Outcomes (6)

• Perseverative Thinking Questionnaire (PTQ)

  up to 20 weeks

• Ruminative Response Scale (RRS)

  up to 20 weeks

• Social Functioning Scale (SFS)

  up to 20 weeks

• Scale for the assessment of positive symptoms (SAPS)

  up to 20 weeks

• Calgary depression scale (CDS)

  up to 20 weeks

Study Arms (2)

rumination-focused cognitive behavioural group therapy

EXPERIMENTAL

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

Treatment as usual

ACTIVE COMPARATOR

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

Interventions

group rumination focused cognitive behavioural therapy OTHER

Psychotherapy

rumination-focused cognitive behavioural group therapy

Treatment as usual OTHER

opus treatment

Treatment as usual

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with a psychosis spectrum disorder (ICD-10 F2x)
• At least 8 months left of their OPUS treatment
• The presence of rumination behavior as assessed by a score of minimum 30 on the Perseverative Thinking Questionnaire (PTQ)
• Danish-speaking

You may not qualify if:

• Substance abuse or positive symptoms that make participation in therapy difficult
• Severe suicidal thoughts/behavior
• Lacks capacity to consent
• Mild, moderate, or severe intellectual disability (IQ ˂ 70)
• Planned adjustment of antidepressant and/or antipsychotic treatment (noted in the patient's medical record)

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead

Study Sites (1)

Mental Health Centre Copenhagen

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Louise B Glenthøj

  Mental health center of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Clemmensen

CONTACT

23492490; lars.clemmensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 10, 2023
• Study Start: August 1, 2023
• Primary Completion: January 31, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)