Clinical trial NCT00791440: Recovery From Psychosis in Schizophrenia - The Impact of Cognitive-Behavioral Therapy
Official title: Psychosis in Schizophrenia: Mechanisms of Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Keywords: Schizophrenia
Schizoaffective
Schizophreniform
Psychosis
Psychotic
Hallucinations
Delusions
Paranoia
Paranoid
Voices
CBT
Cognitive Behavior Therapy
Cognitive Therapy
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-11-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Scale for the Assessment of Positive Symptoms (SAPS)
timeFrame: At Baseline and after 10, 20 and 30 weeks
Secondary outcomes:
measure: Momentary self-report ratings of psychotic symptoms using a Palm computer
timeFrame: At Baseline and after 30 weeks
measure: Momentary self-report ratings of stress and coping strategies using a Palm computer
timeFrame: at Baseline and after 30 weeks
measure: Momentary ambulatory measures of heart rate and breathing
timeFrame: At Baseline and after 30 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University & New York State Psyciatric Institute
state: New York
Study officials:
affiliation: Columbia University & New York State Psyciatric Institute
name: David Kimhy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: