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

Not Applicable

Completed

• Conditions: Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder
• Interventions: Other: Standard Psychiatric Treatment; Behavioral: Cognitive-Behavior Therapy

• Registration Number: NCT00791440
• Lead Sponsor: New York State Psychiatric Institute

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).

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-13
• Study First Submitted QC: 2008-11-13
• Study First Posted: 2008-11-14
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-12
• Last Update Posted: 2012-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Standard Psychiatric Treatment	30 weeks of standard psychiatric treatment.
1	Cognitive-Behavior Therapy	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.

Primary Outcome Measures

Name	Time	Method
Scale for the Assessment of Positive Symptoms (SAPS)	At Baseline and after 10, 20 and 30 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Columbia University & New York State Psyciatric Institute; 🇺🇸 New York, New York, United States