Targeting Stress Reactivity in Schizophrenia: Integrated Coping Awareness Therapy

Schizophreniform Disorders Clinical Trial

— I-CAT  

Official title:

Targeting Stress Reactivity in Schizophrenia: Integrated Coping Awareness Therapy (I-CAT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067311
• Other study ID #: 16-1173
• Secondary ID: 4R33MH100250-03
• Status: Completed
• Phase: N/A
• Start date: October 3, 2016
• Est. completion date: March 30, 2020

Study information

• Verified date: May 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizophrenia
• Schizophreniform Disorders

Intervention

Behavioral:
• I-CAT
I-CAT is a novel therapeutic intervention combining mindfulness and meditation 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).
• Treatment as Usual
Treatment as usual defined by participant clinician at OASIS clinic.

Locations

Country	Name	City	State
United States	UNC OASIS Carrboro	Carrboro	North Carolina
United States	UNC STEP	Carrboro	North Carolina
United States	UNC Oasis Wake	Raleigh	North Carolina
United States	UNC Wake STEP	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change Over Time on the mDES - Positive	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.	Baseline, 4.5, 9, and 12 months
Primary	Change Over Time on the mDES - Negative	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.	Baseline, 4.5, 9, and 12 months
Primary	Change Over Time on the QLS	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.	Baseline, 4.5, 9, and 12 months
Primary	Change Over Time on the FESFS	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.	Baseline, 4.5, 9, and 12 months
Primary	Change Over Time on the PSS	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.	Baseline, 4.5, 9, and 12 months
Primary	Change Over Time on the DSI	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.	Baseline, 4.5, 9, and 12 months
Primary	Change Over Time on Salivary Cortisol Levels	Salivary cortisol levels were collected as a measure of psychological stress.	Baseline, 9 months
Secondary	Change Over Time on the PANSS Total Score	The Positive and Negative Syndrome Scale (PANSS) assessed current symptoms. PANSS items are rated on a seven-point scale with higher scores reflecting more severe symptoms (ICCs for study assessors >.90). Items are summed for a total score (range 30 - 210). Assessed at 4.5 months, 9 months, 12 months.	Baseline, 4.5, 9, and 12 months
Secondary	Change Over Time on the FFMQ	The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item self-report measure assessing facets of being mindful in daily life (i.e., observing, describing, acting with awareness, non-reactivity to inner experience, and non-judging of inner experience). Items are endorsed on a five-point scale (1 = never or rarely true to 5 = very often or always true) and averaged for a total score (range 1-5) with higher scores indicating greater mindfulness ability. Assessed at 4.5 months, 9 months, 12 months.	Baseline, 4.5, 9, and 12 months
Secondary	Change Over Time on the SCS	The Self-Compassion Scale Short Form (SCS) is a 12-item self-report measure of self-compassion. SCS items are endorsed on a five-point scale (1 = almost never to 5 = almost always) and are summed for a total score (range 12 - 60) with higher scores indicating higher levels of self-compassion. Assessed at 4.5 months, 9 months, 12 months.	Baseline, 4.5, 9, and 12 months
Secondary	Change Over Time on the PWB	The Psychological Well-Being Scale (PWB) is a 54-item self-report measure with items endorsed on a seven-point scale (1 = strongly disagree to 6 = strongly agree). Items are summed for a total score (range 54 - 324) with higher scores indicating better psychological well-being. Assessed at 4.5 months, 9 months, 12 months.	Baseline, 4.5, 9, and 12 months
Secondary	Respiratory Sinus Arrhythmia	Index of heart rate variability assessed as the ratio of low-to-high frequencies in the respiratory-cardiac power spectrum. Mean level respiratory sinus arrhythmia (RSA) derived from heart rate monitor worn while participants engaged in a 5-minute mindfulness exercise.	9 months