Cognitive Behavioral Therapy for Patients With an Early Psychosis

October 22, 2014 updated by: Oslo University Hospital

Does Cognitive Behavioral Therapy Improve Depressive Symptoms and Self-Esteem in Patients With a First Episode Psychosis? A Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to nine months after end of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to nine months after end of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Stiftelsen Helse og Rehabilitering

Investigators

  • Principal Investigator: Jan I Røssberg, MD, PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

December 27, 2011

First Submitted That Met QC Criteria

January 17, 2012

First Posted (Estimate)

January 18, 2012

Study Record Updates

Last Update Posted (Estimate)

October 23, 2014

Last Update Submitted That Met QC Criteria

October 22, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBT2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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