Schizoaffective Disorder, Schizophrenia, Schizophreniform Disorder
Conditions
Keywords
Schizophrenia, Schizoaffective, Schizophreniform, Psychosis, Psychotic, Hallucinations, Delusions, Paranoia, Paranoid, Voices, CBT, Cognitive Behavior Therapy, Cognitive Therapy
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).
Interventions
BEHAVIORALCognitive-Behavior Therapy
Weekly individual Cognitive-Behavior Therapy (CBT) to target hallucinations and delusions in addition to standard psychiatric treatment.
Standard psychiatric treatment.
Sponsors
National Institute of Mental Health (NIMH)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scale for the Assessment of Positive Symptoms (SAPS) | At Baseline and after 10, 20 and 30 weeks |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed