Recovery From Psychosis in Schizophrenia - The Impact of Cognitive-Behavioral Therapy - Full Text View

Sponsors and Collaborators:	Columbia University National Institute of Mental Health (NIMH)
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00791440

Purpose

This study examines the impact of Cognitive-Behavior Therapy (CBT) on symptoms, physiological arousal, stressors, and the ways to deal with them in individuals with schizophrenia and related disorders. The primary aim of this study is to investigate the role cognitive coping strategies play in mediating the link between stress, physiological arousal, and psychotic symptoms in individuals with schizophrenia during recovery from psychosis.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder	Behavioral: Cognitive-Behavior Therapy Other: Standard Psychiatric Treatment	Phase III

MedlinePlus related topics: Psychotic Disorders Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Official Title:	Psychosis in Schizophrenia: Mechanisms of Recovery

Further study details as provided by Columbia University:

Primary Outcome Measures:

Scale for the Assessment of Positive Symptoms (SAPS) [ Time Frame: At Baseline and after 10, 20 and 30 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Momentary self-report ratings of psychotic symptoms using a Palm computer [ Time Frame: At Baseline and after 30 weeks ] [ Designated as safety issue: No ]
Momentary self-report ratings of stress and coping strategies using a Palm computer [ Time Frame: at Baseline and after 30 weeks ] [ Designated as safety issue: No ]
Momentary ambulatory measures of heart rate and breathing [ Time Frame: At Baseline and after 30 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	December 2008
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Up to 26-weeks (over a 30 week period) of weekly, individual Cognitive-Behavior Therapy (CBT) to target hallucinations and delusions in addition to standard psychiatric treatment.	Behavioral: Cognitive-Behavior Therapy Weekly individual Cognitive-Behavior Therapy (CBT) to target hallucinations and delusions in addition to standard psychiatric treatment.
2: Active Comparator 30 weeks of standard psychiatric treatment.	Other: Standard Psychiatric Treatment 30 weeks of standard psychiatric treatment.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

English speaking.
Have a diagnosis of schizophrenia, or schizoaffective disorder, or schizophreniform disorder.
Ratings ≥3 for any hallucinations and delusions items on the Scale for Assessment of Positive Symptoms (SAPS).

Exclusion Criteria:

Have a history of heart problems or hypertension.
Regular use of any medications for heart problems or hypertension.
Have used street drugs within the past 4 weeks.
Have history of having suicidal plans or serious self-destructive, violent or aggressive behavior.
Have history of neurological disorders or medical conditions known to seriously affect the brain.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791440

Contacts

Contact: David Kimhy, Ph.D.

212-543-6817

dk553@columbia.edu

Locations

United States, New York
Columbia University & New York State Psyciatric Institute
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

David Kimhy, Ph.D.

Columbia University & New York State Psyciatric Institute

More Information

Responsible Party:	Columbia University ( David Kimhy, Ph.D. )
Study ID Numbers:	ACCESS-IV, K23-MH077653
Study First Received:	November 13, 2008
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00791440
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia University:

Schizophrenia
Schizoaffective
Schizophreniform
Psychosis
Psychotic

Hallucinations
Delusions
Paranoia
Paranoid
Voices

Study placed in the following topic categories:

Schizophrenia
Paranoid Disorders
Delusions
Mental Disorders

Hallucinations
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009