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Completed

NCT Number: NCT00791440

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive-behavior therapy

Behavioral

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

Other names: CBT for psychosis

Standard Psychiatric Treatment

Other

Standard psychiatric treatment.

Other names: Treatment As Usual (TAU)

Primary outcomes

  1. Scale for the Assessment of Positive Symptoms (SAPS)

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

Secondary outcomes

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

    Time frame: At Baseline and after 30 weeks

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

    Time frame: at Baseline and after 30 weeks

  3. Momentary ambulatory measures of heart rate and breathing

    Time frame: At Baseline and after 30 weeks

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Psychosis in Schizophrenia: Mechanisms of Recovery

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Nov 14, 2008
Registry last updated
Dec 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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