RUFUS - Group Rumination-focused CBT for Negative Symptoms

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Psychotic Disorders

Intervention / Treatment
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* Other: group rumination focused cognitive behavioural therapy
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rumination-focused cognitive behavioural group therapy<br>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<br>* Psychotherapy<br>|
| Active Comparator: Treatment as usual<br>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<br>* opus treatment<br>|

What is the study measuring?
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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 |