Schizophrenia Clinical Trial
— I-CATOfficial title:
Targeting Stress Reactivity in Schizophrenia: Integrating Coping Awareness Therapy (I-CAT) Pilot Trial
Integrated Coping and Awareness Therapy is a novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping, as well as a range of possible proximal (e.g. immune indices of stress reactivity, symptom severity) and distal measures (e.g. relapse, quality of life).
Status | Completed |
Enrollment | 6 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Current or past diagnosis of a schizophrenia spectrum disorder. - Has been receiving treatment for psychosis or taking medication for psychosis for less than 5 years. Exclusion Criteria: - Has been hospitalized in the last 3 months. - Currently practicing meditation - Current dependence on alcohol or drugs. - History of significant neurological disorder. - History of serious head injury (i.e., loss of consciousness longer than 15 minutes, no neuropsychological sequelae, no cognitive rehabilitation treatment post head injury). - Illiteracy. - Sensory limitation including visual (e.g., blindness, glaucoma, vision uncorrectable to 20/40) or hearing (e.g. hearing loss) impairments. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Salivary Cortisol at Six Months | Salivary cortisol measured before, during and after a social stressor test. | Baseline, 6 Months | No |
Secondary | Change from Baseline Urinary Oxidative Stress Level [Isoprostane] at Six Months | Baseline, 6 Months | No | |
Secondary | Change from Baseline Positive and Negative Syndrome Scale (PANSS) Total Score at Six Months | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (no current symptomatology) to 210 (severely ill). | Baseline, 6 Months | No |
Secondary | Change from Baseline Quality of Life Scale (QLS; Bilker et al., 2003) Total Score at Six Months | The Quality of Life Scale (QLS) is a semi-structured interview with 7-items that are rated on a 7-point scale with higher ratings reflecting less impaired functioning. | Baseline, 6 Months | No |
Secondary | Change from Baseline Heart Rate Variability (HRV) Measurement at Six Months | Baseline, 6 Months | No | |
Secondary | Change from Baseline Modified Differential Emotions Scale (mDES) Positive Emotion Sub Scale Score at Six Months | Rating scale that identifies strongest experiences of 20 emotions for the past week on a 5-point scale from (0 = not at all to 4= extremely). The mDES includes a Positive and Negative Emotion subscale. | Baseline, 6 Months | No |
Secondary | Change from Baseline Perceived Stress Scale (PSS) Total Score at Six Months | The PSS is a 10-item, well validated and widely used self-report measure of the degree that situations in day-to-day life are perceived as stressful, unpredictable, uncontrollable, and how overloaded subjects find their lives. The 10 items are rated on a 5-point scale that ranges from 0 (never) to 4 (almost always). The PSS total score consists of the sum of the 10 PSS items and ranges from 0 (no subjective experience of stress) to 40 (overwhelmed with stress). | Baseline, 6 Months | No |
Secondary | Change from Baseline Brief COPE Scale (Assisted Format) Total Score at Six Months | A short-version COPE Inventory. Assesses response to stress. 14 scales with two items each; self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion and self-blame. Reliability analyses exceeded alpha=0.60, except for venting, denial and acceptance, all of which exceed alpha = 0.50 (Carver et al 1997) Carver, C. S. (1997). International Journal of Behavioral Medicine, 4, 92-100 | Baseline, 6 Months | No |
Secondary | Change from Baseline Five Facet Mindfulness Questionnaire (FFMQ) Total Score at Six Months | The Five Facet Mindfulness Questionnaire (FFMQ) which assesses the five facets of being mindful in daily life: observing, describing, acting with awareness, non-reactivity to inner experience, and non- judging of inner experience. Each of the 39 items is rated using a Likert-type scale ranging from 1 (never or very rarely true) to 5 (very often or always true). | Baseline, 6 Months | No |
Secondary | Change from Baseline Psychological Well-Being (PWB) Scale Total Score at Six Months | The Psychological Well-Being (PWB) Scale includes six sub scales (autonomy, environmental mastery, personal growth, purpose in life, positive relations with others, and self-acceptance) as well as a total score. The 54 items are rated on a 7-point Likert scale from 1 "strongly disagree" to 7 "strongly agree", with some items being reverse-scored. | Baseline, 6 Months | No |
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