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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| group rumination focused cognitive behavioural therapy | Other | Psychotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Brief Negative Symptoms Scale (BNSS) | Assessment of negative symptoms on a scale from 0-78 | up to 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Perseverative Thinking Questionnaire (PTQ) | Measuring frequency of rumination. Resulting in a total score of 0-60. | up to 20 weeks |
| Ruminative Response Scale (RRS) | Measuring levels of rumination in relation to depression. Resulting in a total score of 22-88. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lars Clemmensen | Contact | 23492490 | lars.clemmensen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Louise B Glenthøj | Mental health center of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mental Health Centre Copenhagen | Recruiting | Copenhagen | Denmark |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as usual | Other | opus treatment |
|
| up to 20 weeks |
| Social Functioning Scale (SFS) | Measuring level of functioning on a scale from of 0-228 | up to 20 weeks |
| Scale for the assessment of positive symptoms (SAPS) | Measuring presence of positive symptoms on a scale from 0-170 | up to 20 weeks |
| Calgary depression scale (CDS) | Measuring depressive symptoms on a scale from 0-27 | up to 20 weeks |
| Behavior Rating Inventory of Executive Function (BRIEF) | Measuring executive functioning on a scale from 75-225 | up to 20 weeks |