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

This study is currently recruiting participants.

Verified December 2011 by New York State Psychiatric Institute

First Received on November 13, 2008. Last Updated on December 9, 2011 History of Changes

Sponsor:	New York State Psychiatric Institute
Collaborator:	National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):	New York State Psychiatric Institute
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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Psychosis in Schizophrenia: Mechanisms of Recovery

Resource links provided by NLM:

MedlinePlus related topics: Mental Disorders Psychotic Disorders Schizophrenia

U.S. FDA Resources

Further study details as provided by New York State Psychiatric Institute:

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:	November 2008
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Up to 26 sessions (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. Other Name: CBT for psychosis
Active Comparator: 2 30 weeks of standard psychiatric treatment.	Other: Standard Psychiatric Treatment Standard psychiatric treatment. Other Name: Treatment As Usual (TAU)

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 on any hallucinations and delusions items of 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	Recruiting
New York, New York, United States, 10032

Sponsors and Collaborators

New York State Psychiatric Institute

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

David Kimhy, Ph.D.

Columbia University & New York State Psyciatric Institute

More Information

No publications provided

Responsible Party:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00791440 History of Changes
Other Study ID Numbers:	5808, K23MH077653
Study First Received:	November 13, 2008
Last Updated:	December 9, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:

Schizophrenia
Schizoaffective
Schizophreniform
Psychosis
Psychotic
Hallucinations
Delusions

Paranoia
Paranoid
Voices
CBT
Cognitive Behavior Therapy
Cognitive Therapy

Additional relevant MeSH terms:

Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 09, 2012