Cognitive Behavioral Therapy for Patients With an Early Psychosis
Does Cognitive Behavioral Therapy Improve Depressive Symptoms and Self-Esteem in Patients With a First Episode Psychosis? A Randomized Controlled Study
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 27, 2011
CompletedFirst Posted
Study publicly available on registry
January 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 23, 2014
October 1, 2014
3.8 years
December 27, 2011
October 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Calgary Depression rating Scale for Schizophrenia (CDSS)
Measure depressive symptoms for patients with a psychosis
up to nine months after end of intervention
Secondary Outcomes (1)
Rosenberg Self Esteem Scale
up to nine months after end of intervention
Study Arms (1)
cognitive behavioral therapy
EXPERIMENTALCognitive behavioral therapy up to 26 sessions
Interventions
Patients allocated to the treatment arm will receive up to 26 sessions of cognitive behavioral therapy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- Stiftelsen Helse og Rehabiliteringcollaborator
Study Sites (1)
Oslo University Hospital
Oslo, Oslo County, 0407, Norway
Related Publications (1)
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.
PMID: 31935529DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan I Røssberg, MD, PhD
Oslo University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2011
First Posted
January 18, 2012
Study Start
January 1, 2011
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
October 23, 2014
Record last verified: 2014-10