Targeting Stress Reactivity in Schizophrenia: Integrated Coping Awareness Therapy (I-CAT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophreniform Disorders
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 38
- Locations
- 4
- Primary Endpoint
- Change Over Time on the mDES - Positive
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
To test the feasibility of a clinical trial implementing I-CAT, a novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping, as well as a range of possible proximal (e.g. autonomic, endocrine, immune indices of stress reactivity, symptom severity) and distal measures (function, relapse, quality of life) for 40 people with first episode psychosis in the context of a small randomized controlled trial.
Detailed Description
Schizophrenia is one of the most devastating disorders that often results in a lack of functional recovery. Current treatments focused on remediating symptoms have shown only small successes in a return to functioning despite evidence of a dysregulated stress response. There is a fundamental gap in understanding the impact of allostatic overload in persons with schizophrenia that the investigators theorize is associated with deficits in functioning and with an increased vulnerability and relapse risk. The long-term goal is to test an intervention aimed at improving stress reactivity. The objective in this application is to develop and test the feasibility of a novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping. The central hypothesis is that an intervention that improves stress reactivity as measured proximally by endocrine, immune, and autonomic indices will result in improved adaptive capacity, better role functioning, reduced risk of relapse, and decreased likelihood of disability for people in the early stages of schizophrenia. The rationale for the proposed research is that stress reactivity may be a modifiable risk factor underlying functional deficits in schizophrenia. The intervention integrates two treatment approaches. The first is based on research showing that mindfulness meditation practice is associated with alterations in the neural processing of stressful events and targets adaptive responses to stress. The second focuses on providing a buffer against stress by using the self-generation of adaptive emotions with a positive psychology intervention, which is potentially associated with building protective social resources. These complimentary interventions provide a comprehensive synergistic approach for this population that could lead to more adaptive coping responses and create a buffer against stress
Investigators
Eligibility Criteria
Inclusion Criteria
- •meets Diagnostic and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for schizophrenia spectrum disorder according diagnostic checklist completed by individual's clinician
- •age 15 to 35, both genders, and any ancestry
- •currently receiving services from UNC OASIS, Schizophrenia Treatment and Evaluation Program (STEP), or a community clinic
- •willing and able to provide informed consent
Exclusion Criteria
- •greater than 8 years of antipsychotic and/or psychological treatment for psychosis
- •Intelligence Quotient (IQ) less than 80
- •low stress level as reported by clinician or participant
- •meets criteria for current substance dependence
- •been hospitalized in the past month
- •actively practicing meditation in the past year
Outcomes
Primary Outcomes
Change Over Time on the mDES - Positive
Time Frame: Baseline, 4.5, 9, and 12 months
The modified self-report Differential Emotion Scale (mDES) assessed the frequency of experiencing discrete emotions from the previous week. Items are endorsed on a five-point scale indicating frequency (0 = not at all, 4 = most of the time). Items are summed to yield positive (mDES - Positive) and negative emotion (mDES - Negative) subscales (range for both 0-40). Higher scores on the positive subscale indicate more positive emotions. Assessed at 4.5 months, 9 months, 12 months.
Change Over Time on the PSS
Time Frame: Baseline, 4.5, 9, and 12 months
The Perceived Stress Scale (PSS) is a ten-item self-report measure of the degree to which daily situations from the past week are perceived as stressful, unpredictable, uncontrollable, as well as how "overloaded" individuals feel (0 = never, 4 = very often). Items are summed for a total score (range 0 - 40) with higher scores indicating more perceived stress. Assessed at 4.5 months, 9 months, 12 months.
Change Over Time on the DSI
Time Frame: Baseline, 4.5, 9, and 12 months
The Daily Stress Inventory (DSI) is a 58-item self-report measure assessing the frequency and intensity of stressful events within the past 24-hours. If an event is endorsed, participants rate the amount of stress the event caused (0 = did not occur, 1 = occurred but was not stressful to 7 = occurred and caused me to panic). The DSI yields an average impact rating (AIR; average impact of ratings given items endorsed \[sum/frequency\]; range 1-7) with higher scores indicating more daily stress. Assessed at 4.5 months, 9 months, 12 months.
Change Over Time on the mDES - Negative
Time Frame: Baseline, 4.5, 9, and 12 months
The modified self-report Differential Emotion Scale (mDES) assessed the frequency of experiencing discrete emotions from the previous week. Items are endorsed on a five-point scale indicating frequency (0 = not at all, 4 = most of the time). Items are summed to yield positive (mDES - Positive) and negative emotion (mDES - Negative) subscales (range for both 0-40). Higher scores on the negative subscale indicate more negative emotions. Assessed at 4.5 months, 9 months, 12 months.
Change Over Time on the QLS
Time Frame: Baseline, 4.5, 9, and 12 months
The Quality of Life Scale (QLS) is a semi-structured 7-item interview with sub scales, including active acquaintances, social initiatives, occupational role functioning, degree of motivation, anhedonia, commonplace objects, and capacity for empathy. The 7-items are rated on a 7-point scale with higher ratings reflecting less impaired functioning (total range 7-49). Assessed at 4.5 months, 9 months, 12 months.
Change Over Time on the FESFS
Time Frame: Baseline, 4.5, 9, and 12 months
The First Episode Social Functioning Scale (FESFS) is a 42-item self-report measure assessing social functioning in early SSD. The FESFS includes a total score and eight subscales assessing: independent living skills, interacting with people in different contexts, social activities, intimacy, friendships, family relations, work, and school. Domain scores are averaged with higher scores reflecting better perceived functioning (range 0-4). Assessed at 4.5 months, 9 months, 12 months.
Change Over Time on Salivary Cortisol Levels
Time Frame: Baseline, 9 months
Salivary cortisol levels were collected as a measure of psychological stress.
Secondary Outcomes
- Change Over Time on the PANSS Total Score(Baseline, 4.5, 9, and 12 months)
- Change Over Time on the PWB(Baseline, 4.5, 9, and 12 months)
- Respiratory Sinus Arrhythmia(9 months)
- Change Over Time on the FFMQ(Baseline, 4.5, 9, and 12 months)
- Change Over Time on the SCS(Baseline, 4.5, 9, and 12 months)