RUFUS - Group Rumination-focused CBT for Negative Symptoms

Mental Health Services in the Capital Region, Denmark

Status: Enrolling

Conditions: Psychotic Disorders

Treatments: Other: group rumination focused cognitive behavioural therapy; Other: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT05851950

05851950

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 37 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

rumination-focused cognitive behavioural group therapy

Experimental group

Description:

1 individual in-take session, 11 sessions of rumination-focused cognitive behavioural group therapy, 1 individual closing session.

Treatment:

Other: group rumination focused cognitive behavioural therapy

Treatment as usual

Active Comparator group

Description:

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.

Treatment:

Other: Treatment as usual