Targeting Stress Reactivity in Schizophrenia: Integrated Coping Awareness Therapy (I-CAT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- Change Over Time on the mDES - Positive
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment as Usual
Usual treatment provided at the University of North Carolina at Chapel Hill (UNC) Outreach and Support Intervention Services (OASIS) Clinic by trained clinicians.
干预措施: Treatment as Usual (Behavioral)
I-CAT
A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians.
干预措施: I-CAT (Behavioral)
结局指标
主要结局
Change Over Time on the mDES - Positive
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline, 9 months
Salivary cortisol levels were collected as a measure of psychological stress.
次要结局
- 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)