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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00791440
Other study ID # 5808
Secondary ID K23MH077653
Status Completed
Phase N/A
First received November 13, 2008
Last updated December 12, 2012
Start date November 2008
Est. completion date June 2012

Study information

Verified date December 2012
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Cognitive-Behavior Therapy
Weekly individual Cognitive-Behavior Therapy (CBT) to target hallucinations and delusions in addition to standard psychiatric treatment.
Other:
Standard Psychiatric Treatment
Standard psychiatric treatment.

Locations

Country Name City State
United States Columbia University & New York State Psyciatric Institute New York New York

Sponsors (2)

Lead Sponsor Collaborator
New York State Psychiatric Institute National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Scale for the Assessment of Positive Symptoms (SAPS) At Baseline and after 10, 20 and 30 weeks No
Secondary Momentary self-report ratings of psychotic symptoms using a Palm computer At Baseline and after 30 weeks No
Secondary Momentary self-report ratings of stress and coping strategies using a Palm computer at Baseline and after 30 weeks No
Secondary Momentary ambulatory measures of heart rate and breathing At Baseline and after 30 weeks No
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