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Trial of Cognitive Behavioral Therapy for Schizophrenia

Phase 3 Randomized Controlled Trial of Cognitive Behavioural Therapy for Patients With Schizophrenia

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00300651
Enrollment
70
Registered
2006-03-09
Start date
2006-03-31
Completion date
2009-08-31
Last updated
2006-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delusional Disorder, Schizoaffective Disorder, Schizophrenia

Keywords

Cognitive Behavioral Therapy, Schizophrenia, Cognitive Biases, Efficacy

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.

Interventions

BEHAVIORALCognitive Behavioral Therapy

Sponsors

Philipps University Marburg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
16 Years to 69 Years
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

Design outcomes

Primary

MeasureTime frame
Positive and Negative Syndrome Scale (PANSS)before and after treatment and at 1-year-follow-up

Secondary

MeasureTime frame
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

Countries

Germany

Contacts

Primary ContactTania M Lincoln, PhD
lincoln@staff.uni-marburg.de+49 (0)6421 2823647
Backup ContactWinfried Rief, Prof.
rief@staff.uni-marburg.de+49 (0)6421 2823641

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026