Cognitive Behavioral Therapy for Patients With an Early Psychosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Stiftelsen Helse og Rehabilitering
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01511406
First received: December 27, 2011
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

The purpose of the present study is to examine whether cognitive behavior therapy will reduce depressive symptoms and increase self-esteem for patients with a first episode psychosis.


Condition Intervention Phase
Psychosis
Schizophrenia
Depressive Symptoms
Self-esteem
Behavioral: cognitive behavioral therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Cognitive Behavioral Therapy Improve Depressive Symptoms and Self-Esteem in Patients With a First Episode Psychosis? A Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Calgary Depression rating Scale for Schizophrenia (CDSS) [ Time Frame: up to nine months after end of intervention ] [ Designated as safety issue: No ]
    Measure depressive symptoms for patients with a psychosis


Secondary Outcome Measures:
  • Rosenberg Self Esteem Scale [ Time Frame: up to nine months after end of intervention ] [ Designated as safety issue: No ]
    Measure the level of self esteem among patients with a psychosis


Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

Hypothesis:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants are eligible for the study if they are diagnosed with a psychotic disorder or bipolar disorder with psychosis according to DSM-IV (i.e. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder or psychosis NOS
  • Aged between 18-65 years
  • Are capable of giving a written consent to participate in the study.

Exclusion Criteria:

  • A history of head injury, neurological disorders, developmental disorders, and all episodes of psychosis being judged as substance-induced rather than a primary episode of a psychotic disorder.
  • Being in treatment for more than five years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01511406

Locations
Norway
Oslo University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Oslo University Hospital
Stiftelsen Helse og Rehabilitering
Investigators
Principal Investigator: Jan I Røssberg, MD, PhD Oslo University Hospital
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01511406     History of Changes
Other Study ID Numbers: CBT2011
Study First Received: December 27, 2011
Last Updated: January 17, 2012
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Oslo University Hospital:
Psychosis
Schizophrenia
Cognitive behavioral therapy
Self esteem
Depression

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia
Depression
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 16, 2014