Cognitive Behavioral Therapy for Patients With an Early Psychosis
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|ClinicalTrials.gov Identifier: NCT01511406|
Recruitment Status : Completed
First Posted : January 18, 2012
Last Update Posted : October 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Psychosis Schizophrenia Depressive Symptoms Self-esteem||Behavioral: cognitive behavioral therapy||Phase 2|
A growing body of evidence supports the use of Cognitive Behavioural Therapy (CBT) for the treatment of schizophrenia. The strength of evidence is especially strong for patients with persistent hallucinations and delusions. As it comes to the effect of CBT for patients with a first episode psychosis the picture is more unclear. The main reason is probably that the CBT interventions to a less extent have been adjusted to fit first episode psychosis patients. The main problems for patients with a first episode psychosis (FEP) is rarely persistent hallucinations and delusions but they struggle with social anxiety, depression, alcohol and drug abuse and low self esteem. Forthcoming studies examining the effect of CBT for patients with a first episode psychosis should aim to have a focus on these symptoms.
The main aim of the present study is to examine whether CBT has any effect on depressive symptoms and self-esteem in patients with a FEP.
The study will include patients with a first episode psychosis with Axis-I DSM IV diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, and psychosis not otherwise specified. To be included in the study the patients should meet the criteria of an affective episode the last year or have a score on Calgary Depression of Schizophrenia Scale above four. Patients are randomly selected to either a treatment group or a control (placebo) group. The aim is to include 30 patients in each group. Patients in the treatment group will receive a manual-based CBT intervention comprising up to 26 sessions during a six months period. The control group will receive treatment as usual (TAU).
The patients are assessed before the entry of the study and after 6 months (end of treatment). Moreover they will be assessed after 9 months of ending therapy.
In this study we hypothesize that
- patients receiving CBT will have less depressive symptoms than TAU-patients at the and of treatment and at six months follow up
- CBT-patients will demonstrate a better improvement in their self-esteem than TAU-patients at the end of treatment and at six months follow up.
To our knowledge, no previous studies have examined outcome after CBT treatment with regards to depressive symptoms and self-esteem. Furthermore, this is the first randomized controlled study in Norway of CBT among patients with a FEP.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Does Cognitive Behavioral Therapy Improve Depressive Symptoms and Self-Esteem in Patients With a First Episode Psychosis? A Randomized Controlled Study|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Experimental: cognitive behavioral therapy
Cognitive behavioral therapy up to 26 sessions
Behavioral: cognitive behavioral therapy
Patients allocated to the treatment arm will receive up to 26 sessions of cognitive behavioral therapy
Other Name: CBT
- Calgary Depression rating Scale for Schizophrenia (CDSS) [ Time Frame: up to nine months after end of intervention ]Measure depressive symptoms for patients with a psychosis
- Rosenberg Self Esteem Scale [ Time Frame: up to nine months after end of intervention ]Measure the level of self esteem among patients with a psychosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511406
|Oslo University Hospital|
|Oslo, Norway, 0407|
|Principal Investigator:||Jan I Røssberg, MD, PhD||Oslo University Hospital|