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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00791440
First received: November 13, 2008
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  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
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
 Behavioral: Cognitive-Behavior Therapy
Other: Standard Psychiatric Treatment

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:

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 ]

Enrollment: 34
Study Start Date: November 2008
Study Completion Date: June 2012
Primary Completion Date: June 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)

Detailed Description:

This study examines the mechanisms of recovery from psychosis. Specifically, the study aims to evaluate the putative impact of enhancing cognitive coping strategies via Cognitive-Behavior Therapy for psychosis (CBTp) on subjective stress, autonomic regulation (physiological arousal), and psychotic symptoms in individuals with schizophrenia and related disorders. As part of the study, participants will be randomized to receive up to 26 weekly sessions of CBTp (over 30 weeks) or "treatment as usual". Research evaluations will completed at baseline, and after 10, 20 and 30 weeks. The study outcome measures include psychotic symptoms as measured by clinical interviews, along with ambulatory measures of autonomic regulation and self-reports of psychotic experiences during daily functioning using mobile devices (i.e., Palm computers).

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females between ages 18-50.
  • Have capacity to give informed consent.
  • English speaking.
  • Have a DSM-IV diagnosis of schizophrenia, or schizoaffective disorder, or schizophreniform disorder.
  • Presence of active psychosis as indexed by ratings ≥3 on any hallucinations and delusions items of the Scale for Assessment of Positive Symptoms (SAPS).

Exclusion Criteria:

  • Lacks capacity to give informed consent.
  • Diagnosis of mental retardation (IQ < 80).
  • Have history of neurological disorders or medical conditions known to seriously affect the brain.
  • Have history of cardiac conditions or hypertension; current use of anti-cholinergic, beta-blockers, anti-histamine, or anti-hypertensive medication; abnormalities on ECG.
  • Have used street drugs within the past 4 weeks.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791440

Locations
United States, New York
Columbia University & New York State Psyciatric Institute
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 12, 2012
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 May 23, 2013