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

NCT ID: NCT00791440

Last Updated: 2012-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-06-30

Brief Summary

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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

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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).

Conditions

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Schizophrenia Schizoaffective Disorder Schizophreniform Disorder

Keywords

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Schizophrenia Schizoaffective Schizophreniform Psychosis Psychotic Hallucinations Delusions Paranoia Paranoid Voices CBT Cognitive Behavior Therapy Cognitive Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Cognitive-Behavior Therapy

Intervention Type BEHAVIORAL

Weekly individual Cognitive-Behavior Therapy (CBT) to target hallucinations and delusions in addition to standard psychiatric treatment.

2

30 weeks of standard psychiatric treatment.

Group Type ACTIVE_COMPARATOR

Standard Psychiatric Treatment

Intervention Type OTHER

Standard psychiatric treatment.

Interventions

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Cognitive-Behavior Therapy

Weekly individual Cognitive-Behavior Therapy (CBT) to target hallucinations and delusions in addition to standard psychiatric treatment.

Intervention Type BEHAVIORAL

Standard Psychiatric Treatment

Standard psychiatric treatment.

Intervention Type OTHER

Other Intervention Names

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CBT for psychosis Treatment As Usual (TAU)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Kimhy, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University & New York State Psyciatric Institute

Locations

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Columbia University & New York State Psyciatric Institute

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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K23MH077653

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5808

Identifier Type: -

Identifier Source: org_study_id