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

Primary Purpose

Psychotic Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
group rumination focused cognitive behavioural therapy
Treatment as usual
Sponsored by
Mental Health Services in the Capital Region, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders

Eligibility Criteria

18 Years - 37 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mental Health Centre CopenhagenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

rumination-focused cognitive behavioural group therapy

Treatment as usual

Arm Description

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

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.

Outcomes

Primary Outcome Measures

the Brief Negative Symptoms Scale (BNSS)
Assessment of negative symptoms on a scale from 0-78

Secondary Outcome Measures

Perseverative Thinking Questionnaire (PTQ)
Measuring frequency of rumination. Resulting in a total score of 0-60.
Ruminative Response Scale (RRS)
Measuring levels of rumination in relation to depression. Resulting in a total score of 22-88.
Social Functioning Scale (SFS)
Measuring level of functioning on a scale from of 0-228
Scale for the assessment of positive symptoms (SAPS)
Measuring presence of positive symptoms on a scale from 0-170
Calgary depression scale (CDS)
Measuring depressive symptoms on a scale from 0-27
Behavior Rating Inventory of Executive Function (BRIEF)
Measuring executive functioning on a scale from 75-225

Full Information

First Posted
May 1, 2023
Last Updated
October 20, 2023
Sponsor
Mental Health Services in the Capital Region, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05851950
Brief Title
RUFUS - Group Rumination-focused CBT for Negative Symptoms
Acronym
RUFUS
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mental Health Services in the Capital Region, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rumination-focused cognitive behavioural group therapy
Arm Type
Experimental
Arm Description
1 individual in-take session, 11 sessions of rumination-focused cognitive behavioural group therapy, 1 individual closing session.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
group rumination focused cognitive behavioural therapy
Intervention Description
Psychotherapy
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
opus treatment
Primary Outcome Measure Information:
Title
the Brief Negative Symptoms Scale (BNSS)
Description
Assessment of negative symptoms on a scale from 0-78
Time Frame
up to 20 weeks
Secondary Outcome Measure Information:
Title
Perseverative Thinking Questionnaire (PTQ)
Description
Measuring frequency of rumination. Resulting in a total score of 0-60.
Time Frame
up to 20 weeks
Title
Ruminative Response Scale (RRS)
Description
Measuring levels of rumination in relation to depression. Resulting in a total score of 22-88.
Time Frame
up to 20 weeks
Title
Social Functioning Scale (SFS)
Description
Measuring level of functioning on a scale from of 0-228
Time Frame
up to 20 weeks
Title
Scale for the assessment of positive symptoms (SAPS)
Description
Measuring presence of positive symptoms on a scale from 0-170
Time Frame
up to 20 weeks
Title
Calgary depression scale (CDS)
Description
Measuring depressive symptoms on a scale from 0-27
Time Frame
up to 20 weeks
Title
Behavior Rating Inventory of Executive Function (BRIEF)
Description
Measuring executive functioning on a scale from 75-225
Time Frame
up to 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Clemmensen
Phone
23492490
Email
lars.clemmensen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise B Glenthøj
Organizational Affiliation
Mental health center of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Centre Copenhagen
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christin Lund
Email
christin.louise.nymann.lund@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

RUFUS - Group Rumination-focused CBT for Negative Symptoms

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