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

New York State Psychiatric Institute34 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Schizophrenia Schizoaffective Disorder Schizophreniform Disorder

Interventions

Cognitive-Behavior TherapyBEHAVIORAL

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

Standard Psychiatric TreatmentOTHER

Standard psychiatric treatment.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Columbia University & New York State Psyciatric Institute

New York, New York, United States

Outcomes

Primary Outcomes

Scale for the Assessment of Positive Symptoms (SAPS)

Time frame: At Baseline and after 10, 20 and 30 weeks

Secondary Outcomes

Momentary self-report ratings of psychotic symptoms using a Palm computer

Time frame: At Baseline and after 30 weeks

Momentary self-report ratings of stress and coping strategies using a Palm computer

Time frame: at Baseline and after 30 weeks

Momentary ambulatory measures of heart rate and breathing

Time frame: At Baseline and after 30 weeks

Data from ClinicalTrials.gov

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