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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH077653 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 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. |
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| 2 | Active Comparator | 30 weeks of standard psychiatric treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavior Therapy | Behavioral | Weekly individual Cognitive-Behavior Therapy (CBT) to target hallucinations and delusions in addition to standard psychiatric treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Scale for the Assessment of Positive Symptoms (SAPS) | At Baseline and after 10, 20 and 30 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Kimhy, Ph.D. | Columbia University & New York State Psyciatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University & New York State Psyciatric Institute | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D001523 | Mental Disorders |
| D006212 | Hallucinations |
| D003702 | Delusions |
| D010259 | Paranoid Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Standard Psychiatric Treatment | Other | Standard psychiatric treatment. |
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| Momentary ambulatory measures of heart rate and breathing | At Baseline and after 30 weeks |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |