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

Study Overview
=================
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).

Official Title
-----------------
Psychosis in Schizophrenia: Mechanisms of Recovery

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder

Intervention / Treatment
-----------------
* Behavioral: Cognitive-Behavior Therapy
* Other: Standard Psychiatric Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Behavioral: Cognitive-Behavior Therapy<br>* Weekly individual Cognitive-Behavior Therapy (CBT) to target hallucinations and delusions in addition to standard psychiatric treatment.<br>* Other names: CBT for psychosis;|
| Active Comparator: 2<br>30 weeks of standard psychiatric treatment. | Other: Standard Psychiatric Treatment<br>* Standard psychiatric treatment.<br>* Other names: Treatment As Usual (TAU);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale for the Assessment of Positive Symptoms (SAPS) |  | At Baseline and after 10, 20 and 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Momentary self-report ratings of psychotic symptoms using a Palm computer |  | 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 ambulatory measures of heart rate and breathing |  | At Baseline and after 30 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Schizoaffective, Schizophreniform, Psychosis, Psychotic, Hallucinations, Delusions, Paranoia, Paranoid, Voices, CBT, Cognitive Behavior Therapy, Cognitive Therapy