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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00791440
First received: November 13, 2008
Last updated: December 12, 2012
Last verified: December 2012

November 13, 2008
December 12, 2012
November 2008
June 2012   (final data collection date for primary outcome measure)
Scale for the Assessment of Positive Symptoms (SAPS) [ Time Frame: At Baseline and after 10, 20 and 30 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00791440 on ClinicalTrials.gov Archive Site
  • Momentary self-report ratings of psychotic symptoms using a Palm computer [ Time Frame: At Baseline and after 30 weeks ] [ Designated as safety issue: No ]
  • Momentary self-report ratings of stress and coping strategies using a Palm computer [ Time Frame: at Baseline and after 30 weeks ] [ Designated as safety issue: No ]
  • Momentary ambulatory measures of heart rate and breathing [ Time Frame: At Baseline and after 30 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Recovery From Psychosis in Schizophrenia - The Impact of Cognitive-Behavioral Therapy
Psychosis in Schizophrenia: Mechanisms of Recovery

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • Schizophreniform Disorder
  • Behavioral: Cognitive-Behavior Therapy
    Weekly individual Cognitive-Behavior Therapy (CBT) to target hallucinations and delusions in addition to standard psychiatric treatment.
    Other Name: CBT for psychosis
  • Other: Standard Psychiatric Treatment
    Standard psychiatric treatment.
    Other Name: Treatment As Usual (TAU)
  • Experimental: 1
    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.
    Intervention: Behavioral: Cognitive-Behavior Therapy
  • Active Comparator: 2
    30 weeks of standard psychiatric treatment.
    Intervention: Other: Standard Psychiatric Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00791440
5808, K23MH077653
No
New York State Psychiatric Institute
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Principal Investigator: David Kimhy, Ph.D. Columbia University & New York State Psyciatric Institute
New York State Psychiatric Institute
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP