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RUFUS - Group Rumination-focused CBT for Negative Symptoms

NCT05851950 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-10-23

No results posted yet for this study

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

Interventions

OTHER

group rumination focused cognitive behavioural therapy

Psychotherapy

OTHER

Treatment as usual

opus treatment

Sponsors & Collaborators

  • Mental Health Services in the Capital Region, Denmark

    lead OTHER

Principal Investigators

  • Louise B Glenthøj · Mental health center of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
37 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-01-31
Completion
2026-07-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05851950 on ClinicalTrials.gov