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

Schizophrenia Clinical Trial

Official title:

Psychosis in Schizophrenia: Mechanisms of Recovery

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

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder

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