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RUFUS - Group Rumination-focused CBT for Negative Symptoms (RUFUS)

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ClinicalTrials.gov Identifier: NCT05851950
Recruitment Status : Recruiting
First Posted : May 10, 2023
Last Update Posted : October 23, 2023
Sponsor:
Information provided by (Responsible Party):
Mental Health Services in the Capital Region, Denmark

Tracking Information
First Submitted Date  ICMJE May 1, 2023
First Posted Date  ICMJE May 10, 2023
Last Update Posted Date October 23, 2023
Actual Study Start Date  ICMJE August 1, 2023
Estimated Primary Completion Date January 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2023)
the Brief Negative Symptoms Scale (BNSS) [ Time Frame: up to 20 weeks ]
Assessment of negative symptoms on a scale from 0-78
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2023)
  • Perseverative Thinking Questionnaire (PTQ) [ Time Frame: up to 20 weeks ]
    Measuring frequency of rumination. Resulting in a total score of 0-60.
  • Ruminative Response Scale (RRS) [ Time Frame: up to 20 weeks ]
    Measuring levels of rumination in relation to depression. Resulting in a total score of 22-88.
  • Social Functioning Scale (SFS) [ Time Frame: up to 20 weeks ]
    Measuring level of functioning on a scale from of 0-228
  • Scale for the assessment of positive symptoms (SAPS) [ Time Frame: up to 20 weeks ]
    Measuring presence of positive symptoms on a scale from 0-170
  • Calgary depression scale (CDS) [ Time Frame: up to 20 weeks ]
    Measuring depressive symptoms on a scale from 0-27
  • Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: up to 20 weeks ]
    Measuring executive functioning on a scale from 75-225
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RUFUS - Group Rumination-focused CBT for Negative Symptoms
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psychotic Disorders
Intervention  ICMJE
  • Other: group rumination focused cognitive behavioural therapy
    Psychotherapy
  • Other: Treatment as usual
    opus treatment
Study Arms  ICMJE
  • Experimental: rumination-focused cognitive behavioural group therapy
    1 individual in-take session, 11 sessions of rumination-focused cognitive behavioural group therapy, 1 individual closing session.
    Intervention: Other: group rumination focused cognitive behavioural therapy
  • Active Comparator: 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.
    Intervention: Other: Treatment as usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 1, 2023)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2026
Estimated Primary Completion Date January 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 37 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lars Clemmensen 23492490 lars.clemmensen@regionh.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05851950
Other Study ID Numbers  ICMJE 05851950
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Mental Health Services in the Capital Region, Denmark
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mental Health Services in the Capital Region, Denmark
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Louise B Glenthøj Mental health center of Copenhagen
PRS Account Mental Health Services in the Capital Region, Denmark
Verification Date October 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP