Psychotic Disorders
Conditions
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.
Interventions
OTHERgroup rumination focused cognitive behavioural therapy
Psychotherapy
OTHERTreatment as usual
opus treatment
Sponsors
Mental Health Services in the Capital Region, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 37 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Brief Negative Symptoms Scale (BNSS) | up to 20 weeks | Assessment of negative symptoms on a scale from 0-78 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perseverative Thinking Questionnaire (PTQ) | up to 20 weeks | Measuring frequency of rumination. Resulting in a total score of 0-60. |
| Ruminative Response Scale (RRS) | up to 20 weeks | Measuring levels of rumination in relation to depression. Resulting in a total score of 22-88. |
| Social Functioning Scale (SFS) | up to 20 weeks | Measuring level of functioning on a scale from of 0-228 |
| Calgary depression scale (CDS) | up to 20 weeks | Measuring depressive symptoms on a scale from 0-27 |
| Behavior Rating Inventory of Executive Function (BRIEF) | up to 20 weeks | Measuring executive functioning on a scale from 75-225 |
| Scale for the assessment of positive symptoms (SAPS) | up to 20 weeks | Measuring presence of positive symptoms on a scale from 0-170 |
Countries
Denmark
Contacts
Primary ContactLars Clemmensen
Outcome results
None listed