Psychotic DisordersRUFUSNCT05851950
RUFUS - Group Rumination-focused CBT for Negative Symptoms
A study testing group rumination focused cognitive behavioural therapy and Treatment as usual in people with Psychotic Disorders, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 37 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- group rumination focused cognitive behavioural therapy and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2023to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 37 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Mental Health Centre Copenhagen
Copenhagen
Christin Lund, christin.louise.nymann.lund@regionh.dk
About this study
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
Abstract - --
Introduction:
Read more
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.
- Conditions
- Psychotic Disorders
- Being tested
- group rumination focused cognitive behavioural therapy, Treatment as usual
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group rumination focused cognitive behavioural therapyOther
Psychotherapy
Treatment as usualOther
opus treatment
| Study group | Role | What they receive |
|---|---|---|
| rumination-focused cognitive behavioural group therapy | Experimental | 1 individual in-take session, 11 sessions of rumination-focused cognitive behavioural group therapy, 1 individual closing session. Receives: Other: group rumination focused cognitive behavioural therapy |
| Treatment as usual | Active comparator | 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. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Brief Negative Symptoms Scale (BNSS)
Assessment of negative symptoms on a scale from 0-78
Measured: up to 20 weeks
Secondary outcomes (6)
Perseverative Thinking Questionnaire (PTQ)
Measuring frequency of rumination. Resulting in a total score of 0-60.
Measured: up to 20 weeks
Ruminative Response Scale (RRS)
Measuring levels of rumination in relation to depression. Resulting in a total score of 22-88.
Measured: up to 20 weeks
Social Functioning Scale (SFS)
Measuring level of functioning on a scale from of 0-228
Measured: up to 20 weeks
Scale for the assessment of positive symptoms (SAPS)
Measuring presence of positive symptoms on a scale from 0-170
Measured: up to 20 weeks
Calgary depression scale (CDS)
Measuring depressive symptoms on a scale from 0-27
Measured: up to 20 weeks
Behavior Rating Inventory of Executive Function (BRIEF)
Measuring executive functioning on a scale from 75-225
Measured: up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Aug 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise B Glenthøj, Principal investigator, Mental health center of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851950
- Sponsor's protocol ID
- 05851950
- Acronym
- RUFUS
- Status last verified
- Oct 2023
- First submitted
- 1 May 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05851950
- Acronym / sponsor ID
- RUFUS / 05851950
- Conditions
- Psychotic Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rumination-focused cognitive behavioural group therapy | Experimental | Other: group rumination focused cognitive behavioural therapy1 individual in-take session, 11 sessions of rumination-focused cognitive behavioural group therapy, 1 individual closing session. |
| Treatment as usual | Active comparator | Other: Treatment as usualstandard 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. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group rumination focused cognitive behavioural therapyPsychotherapy | Other | rumination-focused cognitive behavioural group therapy |
| Treatment as usualopus treatment | Other | Treatment as usual |
Primary outcome
the Brief Negative Symptoms Scale (BNSS)
Time frame: up to 20 weeks
Assessment of negative symptoms on a scale from 0-78
6 secondary outcomes
Perseverative Thinking Questionnaire (PTQ)
Time frame: up to 20 weeks
Ruminative Response Scale (RRS)
Time frame: up to 20 weeks
Social Functioning Scale (SFS)
Time frame: up to 20 weeks
Scale for the assessment of positive symptoms (SAPS)
Time frame: up to 20 weeks
Calgary depression scale (CDS)
Time frame: up to 20 weeks
Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: up to 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise B Glenthøj principal investigator
Mental health center of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group rumination focused cognitive behavioural therapy and Treatment as usual in people with Psychotic Disorders, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Clemmensen (23492490, lars.clemmensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Brief Negative Symptoms Scale (BNSS) (time frame: up to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.