Phase 3 Randomized Controlled Trial of Cognitive Behavioural Therapy for Patients With Schizophrenia
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Philipps University Marburg
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Positive and Negative Syndrome Scale (PANSS)before and after treatment and at 1-year-follow-up
Study Overview
Brief Summary
The following study addresses the hypothesis that cognitive-behavioral interventions will be effective in reducing positive and negative symptoms of schizophrenia under the conditions of the German health care system. It is also hypothesized that interventions designed to reduce delusions will reduce cognitive biases and dysfunctional self-concepts.
Detailed Description
Background: In spite of the proven effectiveness in a series of randomized controlled studies, cognitive-behavioural interventions for the treatment of symptoms of schizophrenia have been not yet been evaluated under the conditions of the German health care system. Additionally, it remains unclear which processes are responsible for reducing positive symptoms using CBT-interventions.
Hypothesis
The following study addresses the hypothesis that CBT will be effective in reducing positive and negative symptoms of schizophrenia. It is also hypothesized that CBT will reduce cognitive biases and dysfunctional self-concepts.
Method: 70 patients with a primary diagnosis of schizophrenia will be randomized to a CBT-treatment- and a waiting-list-control-group. CBT involves a formulation-based treatment of approximately 25 sessions by trained and supervised therapists plus standard care (psychiatric medical treatment) in an outpatient setting. Participants will be referred from cooperating psychiatrists. Patients randomized to the waiting-list condition take part in the assessment phase, then receive standard care alone for 12 weeks and are then offered CBT. The primary outcome measure will be the Positive and Negative Syndrome Scale. Additionally, depression, dysfunctional self-concepts and cognitive biases will be assessed before and after treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 16 Years to 69 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •persons with a primary diagnosis of schizophrenia, schizoaffective disorder, delusional disorder acute or in incomplete remission a value of at least 3 on delusions, P1, P3 or G9 in Positive and Negative Syndrome Scale
- •fluent in German language
Exclusion Criteria
- •severe organic brain disease
Outcomes
Primary Outcomes
Positive and Negative Syndrome Scale (PANSS)before and after treatment and at 1-year-follow-up
Secondary Outcomes
- Depression before and after treatment and at 1-year-follow-up
- Dysfunctional Attitudes before and after treatment and at 1-year-follow-up
- Cognitive biases (jumping to conclusions, attribution, theory of mind) before and after treatment