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

New York State Psychiatric Institute

Status: Completed

Conditions: Schizophreniform Disorder; Schizophrenia; Schizoaffective Disorder

Treatments: Behavioral: Cognitive-Behavior Therapy; Other: Standard Psychiatric Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00791440

K23MH077653 (U.S. NIH Grant/Contract)

5808

Details and patient eligibility

About

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.

Full 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).

Enrollment: 34 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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34 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive-Behavior Therapy

2

Active Comparator group

Description:

30 weeks of standard psychiatric treatment.

Treatment:

Other: Standard Psychiatric Treatment