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

Primary Purpose

Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavior Therapy
Standard Psychiatric Treatment
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective, Schizophreniform, Psychosis, Psychotic, Hallucinations, Delusions, Paranoia, Paranoid, Voices, CBT, Cognitive Behavior Therapy, Cognitive Therapy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Columbia University & New York State Psyciatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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.

30 weeks of standard psychiatric treatment.

Outcomes

Primary Outcome Measures

Scale for the Assessment of Positive Symptoms (SAPS)

Secondary Outcome Measures

Momentary self-report ratings of psychotic symptoms using a Palm computer
Momentary self-report ratings of stress and coping strategies using a Palm computer
Momentary ambulatory measures of heart rate and breathing

Full Information

First Posted
November 13, 2008
Last Updated
December 12, 2012
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00791440
Brief Title
Recovery From Psychosis in Schizophrenia - The Impact of Cognitive-Behavioral Therapy
Official Title
Psychosis in Schizophrenia: Mechanisms of Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
Keywords
Schizophrenia, Schizoaffective, Schizophreniform, Psychosis, Psychotic, Hallucinations, Delusions, Paranoia, Paranoid, Voices, CBT, Cognitive Behavior Therapy, Cognitive Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
30 weeks of standard psychiatric treatment.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavior Therapy
Other Intervention Name(s)
CBT for psychosis
Intervention Description
Weekly individual Cognitive-Behavior Therapy (CBT) to target hallucinations and delusions in addition to standard psychiatric treatment.
Intervention Type
Other
Intervention Name(s)
Standard Psychiatric Treatment
Other Intervention Name(s)
Treatment As Usual (TAU)
Intervention Description
Standard psychiatric treatment.
Primary Outcome Measure Information:
Title
Scale for the Assessment of Positive Symptoms (SAPS)
Time Frame
At Baseline and after 10, 20 and 30 weeks
Secondary Outcome Measure Information:
Title
Momentary self-report ratings of psychotic symptoms using a Palm computer
Time Frame
At Baseline and after 30 weeks
Title
Momentary self-report ratings of stress and coping strategies using a Palm computer
Time Frame
at Baseline and after 30 weeks
Title
Momentary ambulatory measures of heart rate and breathing
Time Frame
At Baseline and after 30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kimhy, Ph.D.
Organizational Affiliation
Columbia University & New York State Psyciatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University & New York State Psyciatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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

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