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

December 12, 2012 updated by: New York State Psychiatric Institute

Psychosis in Schizophrenia: Mechanisms of Recovery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • CBT for psychosis
ACTIVE_COMPARATOR: 2
30 weeks of standard psychiatric treatment.
Other: Standard Psychiatric Treatment
Standard psychiatric treatment.
Other Names:
  • Treatment As Usual (TAU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Scale for the Assessment of Positive Symptoms (SAPS)
Time Frame: At Baseline and after 10, 20 and 30 weeks
At Baseline and after 10, 20 and 30 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Momentary self-report ratings of psychotic symptoms using a Palm computer
Time Frame: At Baseline and after 30 weeks
At Baseline and after 30 weeks
Momentary self-report ratings of stress and coping strategies using a Palm computer
Time Frame: at Baseline and after 30 weeks
at Baseline and after 30 weeks
Momentary ambulatory measures of heart rate and breathing
Time Frame: At Baseline and after 30 weeks
At Baseline and after 30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: David Kimhy, Ph.D., Columbia University & New York State Psyciatric Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

November 13, 2008

First Submitted That Met QC Criteria

November 13, 2008

First Posted (ESTIMATE)

November 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 13, 2012

Last Update Submitted That Met QC Criteria

December 12, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5808
  • K23MH077653 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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