An interventional study of group rumination focused cognitive behavioural therapy and Treatment as usual in Psychotic Disorders, sponsored by Mental Health Services in the Capital Region, Denmark. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 37 Years. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Mental Health Services in the Capital Region, Denmark · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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
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
Psychotherapy
opus treatment
the Brief Negative Symptoms Scale (BNSS)
Assessment of negative symptoms on a scale from 0-78
Time frame: up to 20 weeks
Perseverative Thinking Questionnaire (PTQ)
Measuring frequency of rumination. Resulting in a total score of 0-60.
Time frame: up to 20 weeks
Ruminative Response Scale (RRS)
Measuring levels of rumination in relation to depression. Resulting in a total score of 22-88.
Time frame: up to 20 weeks
Social Functioning Scale (SFS)
Measuring level of functioning on a scale from of 0-228
Time frame: up to 20 weeks
Scale for the assessment of positive symptoms (SAPS)
Measuring presence of positive symptoms on a scale from 0-170
Time frame: up to 20 weeks
Calgary depression scale (CDS)
Measuring depressive symptoms on a scale from 0-27
Time frame: up to 20 weeks
Behavior Rating Inventory of Executive Function (BRIEF)
Measuring executive functioning on a scale from 75-225
Time frame: up to 20 weeks
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mental Health Services in the Capital Region, Denmark