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

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

Tracking Information

• First Submitted Date: May 1, 2023
• First Posted Date: May 10, 2023
• Last Update Posted Date: October 23, 2023
• Actual Study Start Date: August 1, 2023
• Estimated Primary Completion Date: January 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: RUFUS - Group Rumination-focused CBT for Negative Symptoms
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Psychotic Disorders

Intervention

• Other: group rumination focused cognitive behavioural therapy
  Psychotherapy
• Other: Treatment as usual
  opus treatment

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 1, 2023): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 1, 2026
• Estimated Primary Completion Date: January 31, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 37 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Lars Clemmensen; 23492490; lars.clemmensen@regionh.dk

• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT05851950
• Other Study ID Numbers: 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

• 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: Mental Health Services in the Capital Region, Denmark
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Louise B Glenthøj; Mental health center of Copenhagen

• PRS Account: Mental Health Services in the Capital Region, Denmark
• Verification Date: October 2023