Cognitive Behavioral Therapy for Patients With an Early Psychosis
Primary Purpose
Psychosis, Schizophrenia, Depressive Symptoms
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
cognitive behavioral therapy
Sponsored by
About this trial
This is an interventional treatment trial for Psychosis focused on measuring Psychosis, Schizophrenia, Cognitive behavioral therapy, Self esteem, Depression
Eligibility 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
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cognitive behavioral therapy
Arm Description
Cognitive behavioral therapy up to 26 sessions
Outcomes
Primary Outcome Measures
Calgary Depression rating Scale for Schizophrenia (CDSS)
Measure depressive symptoms for patients with a psychosis
Secondary Outcome Measures
Rosenberg Self Esteem Scale
Measure the level of self esteem among patients with a psychosis
Full Information
NCT ID
NCT01511406
First Posted
December 27, 2011
Last Updated
October 22, 2014
Sponsor
Oslo University Hospital
Collaborators
Stiftelsen Helse og Rehabilitering
1. Study Identification
Unique Protocol Identification Number
NCT01511406
Brief Title
Cognitive Behavioral Therapy for Patients With an Early Psychosis
Official Title
Does Cognitive Behavioral Therapy Improve Depressive Symptoms and Self-Esteem in Patients With a First Episode Psychosis? A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo University Hospital
Collaborators
Stiftelsen Helse og Rehabilitering
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Schizophrenia, Depressive Symptoms, Self-esteem
Keywords
Psychosis, Schizophrenia, Cognitive behavioral therapy, Self esteem, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cognitive behavioral therapy
Arm Type
Experimental
Arm Description
Cognitive behavioral therapy up to 26 sessions
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral therapy
Other Intervention Name(s)
CBT
Intervention Description
Patients allocated to the treatment arm will receive up to 26 sessions of cognitive behavioral therapy
Primary Outcome Measure Information:
Title
Calgary Depression rating Scale for Schizophrenia (CDSS)
Description
Measure depressive symptoms for patients with a psychosis
Time Frame
up to nine months after end of intervention
Secondary Outcome Measure Information:
Title
Rosenberg Self Esteem Scale
Description
Measure the level of self esteem among patients with a psychosis
Time Frame
up to nine months after end of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan I Røssberg, MD, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
31935529
Citation
Sonmez N, Romm KL, Ostefjells T, Grande M, Jensen LH, Hummelen B, Tesli M, Melle I, Rossberg JI. Cognitive behavior therapy in early psychosis with a focus on depression and low self-esteem: A randomized controlled trial. Compr Psychiatry. 2020 Feb;97:152157. doi: 10.1016/j.comppsych.2019.152157. Epub 2019 Dec 26.
Results Reference
derived
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Cognitive Behavioral Therapy for Patients With an Early Psychosis
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