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

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT03067311
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 38
• Locations: 4
• Arms: 2
• Actual Duration (Months): 41.9
• Patients Per Site: 9.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophreniform Disorders	Behavioral: I-CAT; Behavioral: Treatment as Usual	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Targeting Stress Reactivity in Schizophrenia: Integrated Coping Awareness Therapy (I-CAT)
• Actual Study Start Date: Oct 3, 2016
• Actual Primary Completion Date: Mar 30, 2020
• Actual Study Completion Date: Mar 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: I-CAT A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians.	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).
Active Comparator: 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.	Behavioral: Treatment as Usual; Treatment as usual defined by participant clinician at OASIS clinic.

Outcome Measures

Primary Outcome Measures

1. Change Over Time on the mDES - Positive [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.

2. Change Over Time on the mDES - Negative [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.

3. Change Over Time on the QLS [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.

4. Change Over Time on the FESFS [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.

5. Change Over Time on the PSS [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.

6. Change Over Time on the DSI [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.

7. Change Over Time on Salivary Cortisol Levels [Baseline, 9 months]

   Salivary cortisol levels were collected as a measure of psychological stress.

Secondary Outcome Measures

1. Change Over Time on the PANSS Total Score [Baseline, 4.5, 9, and 12 months]

   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.

2. Change Over Time on the FFMQ [Baseline, 4.5, 9, and 12 months]

   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.

3. Change Over Time on the SCS [Baseline, 4.5, 9, and 12 months]

   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.

4. Change Over Time on the PWB [Baseline, 4.5, 9, and 12 months]

   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.

5. Respiratory Sinus Arrhythmia [9 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UNC OASIS Carrboro	Carrboro	North Carolina	United States	27510
2	UNC STEP	Carrboro	North Carolina	United States	27510
3	UNC Oasis Wake	Raleigh	North Carolina	United States	27603
4	UNC Wake STEP	Raleigh	North Carolina	United States	27610

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: David L Penn, PhD, The Unviersity of North Carolina at Chapel Hill
• Principal Investigator: Diana Perkins, MD, The Unviersity of North Carolina at Chapel Hill
• Principal Investigator: Piper S Meyer-Kalos, PhD, Minnesota Center for Chemical and Mental Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 10, 2020

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT03067311
• Other Study ID Numbers: 16-1173; 4R33MH100250-03
• First Posted: Mar 1, 2017
• Last Update Posted: Mar 3, 2021
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Schizophrenia; Psychotic Disorders

Study Results

Participant Flow

Arm/Group Title	I-CAT	Treatment as Usual
Arm/Group Description	A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. 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).	Usual treatment provided at the University of North Carolina at Chapel Hill (UNC) OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
Period Title: Overall Study
STARTED	19	19
COMPLETED	17	17
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	I-CAT	Treatment as Usual	Total
Arm/Group Description	A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. 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).	Usual treatment provided at the UNC OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.	Total of all reporting groups
Overall Participants	19	19	38
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	19 100%	19 100%	38 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23.6 (4.3)	24.9 (3.9)	24.3 (4.1)
Sex: Female, Male (Count of Participants)
Female	9 47.4%	9 47.4%	18 47.4%
Male	10 52.6%	10 52.6%	20 52.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 21.1%	1 5.3%	5 13.2%
Not Hispanic or Latino	15 78.9%	18 94.7%	33 86.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 5.3%	1 5.3%	2 5.3%
Asian	2 10.5%	2 10.5%	4 10.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 26.3%	2 10.5%	7 18.4%
White	11 57.9%	14 73.7%	25 65.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	19 100%	19 100%	38 100%
WASI-II Intelligence Quotient (IQ) Score (t-score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [t-score]	107.7 (14.1)	111.5 (12)	109.6 (13.05)
Duration of Illness (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	1.7 (1.5)	1.8 (2)	1.8 (1.8)
PANSS Total (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	62.3 (17.2)	58.4 (16)	60.4 (16.6)
mDES - Positive Emotions (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	21.3 (6.9)	20.9 (9.3)	21.1 (8.1)
mDES - Negative Emotions (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	15.6 (8.7)	18.2 (10.6)	16.9 (9.65)
Quality of Life Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	26 (8.3)	25.3 (7.2)	25.7 (7.8)
First Episode Social Functioning Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3 (0.4)	3.2 (0.5)	3.1 (0.45)
Perceived Stress Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	18.8 (6.3)	20.9 (8.5)	19.9 (7.4)
Daily Stress Inventory (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.0 (1.3)	2.9 (1.2)	2.95 (1.25)
Five Facets of Mindfulness Questionnaire (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3 (0.4)	3 (0.6)	3 (0.5)
Self-Compassion Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	34.7 (7)	35.7 (9.7)	35.2 (8.35)
Perceived Well-Being Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	207.9 (36.8)	209.32 (46.8)	208.61 (41.8)

Outcome Measures

1. Primary Outcome

Title	Change Over Time on the mDES - Positive
Description	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.
Time Frame	Baseline, 4.5, 9, and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I-CAT	Treatment as Usual
Arm/Group Description	A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. 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).	Usual treatment provided at the UNC OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
Measure Participants	17	17
4.5 months change from baseline	0.35 (0.19)	0.42 (0.20)
9 months change from baseline	0.62 (0.19)	0.25 (0.19)
12 months change from baseline	0.28 (0.19)	0.38 (0.21)

2. Primary Outcome

Title	Change Over Time on the mDES - Negative
Description	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.
Time Frame	Baseline, 4.5, 9, and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I-CAT	Treatment as Usual
Arm/Group Description	A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. 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).	Usual treatment provided at the UNC OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
Measure Participants	17	17
4.5 months change from baseline	0.01 (0.17)	-0.38 (0.20)
9 months change from baseline	-0.27 (0.17)	-0.19 (0.19)
12 months change from baseline	-0.01 (0.19)	-0.24 (0.20)

3. Primary Outcome

Title	Change Over Time on the QLS
Description	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.
Time Frame	Baseline, 4.5, 9, and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I-CAT	Treatment as Usual
Arm/Group Description	A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. 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).	Usual treatment provided at the UNC OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
Measure Participants	17	17
4.5 months change from baseline	0.10 (0.16)	0.36 (0.78)
9 months change from baseline	0.26 (0.16)	0.28 (0.18)
12 months change from baseline	0.74 (0.16)	0.91 (0.18)

4. Primary Outcome

Title	Change Over Time on the FESFS
Description	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.
Time Frame	Baseline, 4.5, 9, and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I-CAT	Treatment as Usual
Arm/Group Description	A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. 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).	Usual treatment provided at the UNC OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
Measure Participants	17	17
4.5 months change from baseline	-0.07 (0.14)	0.04 (0.16)
9 months change from baseline	0.22 (0.15)	0.20 (0.15)
12 months change from baseline	0.40 (0.15)	0.33 (0.17)

5. Primary Outcome

Title	Change Over Time on the PSS
Description	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.
Time Frame	Baseline, 4.5, 9, and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I-CAT	Treatment as Usual
Arm/Group Description	A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. 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).	Usual treatment provided at the UNC OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
Measure Participants	17	17
4.5 months change from baseline	-0.26 (0.19)	-0.46 (0.23)
9 months change from baseline	-0.36 (0.19)	-0.44 (0.20)
12 months change from baseline	-0.16 (0.20)	-0.52 (0.22)

6. Primary Outcome

Title	Change Over Time on the DSI
Description	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.
Time Frame	Baseline, 4.5, 9, and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I-CAT	Treatment as Usual
Arm/Group Description	A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. 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).	Usual treatment provided at the UNC OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
Measure Participants	17	17
4.5 months change from baseline	0.09 (0.23)	-0.09 (0.23)
9 months change from baseline	0.46 (0.22)	-0.12 (0.23)
12 months change from baseline	-0.41 (0.24)	-0.51 (0.25)

7. Primary Outcome

Title	Change Over Time on Salivary Cortisol Levels
Description	Salivary cortisol levels were collected as a measure of psychological stress.
Time Frame	Baseline, 9 months

Outcome Measure Data

Analysis Population Description

Saliva samples unable to be collected from all participants.

Arm/Group Title	I-CAT	Treatment as Usual
Arm/Group Description	A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. 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).	Usual treatment provided at the UNC OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
Measure Participants	17	12
Least Squares Mean (Standard Error) [ug/dL]	0.0254 (0.0240)	-0.0124 (0.0274)

8. Secondary Outcome

Title	Change Over Time on the PANSS Total Score
Description	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.
Time Frame	Baseline, 4.5, 9, and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I-CAT	Treatment as Usual
Arm/Group Description	A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. 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).	Usual treatment provided at the UNC OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
Measure Participants	17	17
4.5 months change from baseline	-0.49 (0.15)	-0.29 (0.16)
9 months change from baseline	-0.81 (0.15)	-0.29 (0.16)
12 months change from baseline	-1.00 (0.15)	-0.66 (0.17)

9. Secondary Outcome

Title	Change Over Time on the FFMQ
Description	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.
Time Frame	Baseline, 4.5, 9, and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I-CAT	Treatment as Usual
Arm/Group Description	A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. 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).	Usual treatment provided at the UNC OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
Measure Participants	17	17
4.5 months change from baseline	0.18 (0.144)	0.51 (0.15)
9 months change from baseline	0.35 (0.14)	0.26 (0.14)
12 months change from baseline	0.26 (0.14)	0.13 (0.15)

10. Secondary Outcome

Title	Change Over Time on the SCS
Description	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.
Time Frame	Baseline, 4.5, 9, and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I-CAT	Treatment as Usual
Arm/Group Description	A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. 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).	Usual treatment provided at the UNC OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
Measure Participants	17	17
4.5 months change from baseline	-0.06 (0.18)	0.30 (0.20)
9 months change from baseline	0.11 (0.18)	0.27 (0.19)
12 months change from baseline	0.04 (0.19)	0.13 (0.20)

11. Secondary Outcome

Title	Change Over Time on the PWB
Description	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.
Time Frame	Baseline, 4.5, 9, and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I-CAT	Treatment as Usual
Arm/Group Description	A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. 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).	Usual treatment provided at the UNC OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
Measure Participants	17	17
4.5 months change from baseline	0.21 (0.14)	0.17 (0.15)
9 months change from baseline	0.36 (0.14)	-0.01 (0.15)
12 months change from baseline	0.29 (0.14)	0.12 (0.16)

12. Secondary Outcome

Title	Respiratory Sinus Arrhythmia
Description	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.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

Data not available for all participants due to device technical issues or post-treatment appointment completed remotely.

Arm/Group Title	I-CAT	Treatment as Usual
Arm/Group Description	A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. 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).	Usual treatment provided at the UNC OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
Measure Participants	9	11
Least Squares Mean (Standard Error) [ln(msec)^2]	4.58 (0.520)	6.15 (0.562)

Adverse Events

Time Frame	From baseline to study follow-up, a total of approximately 12 months.
Arm/Group Title	I-CAT		Treatment as Usual
Arm/Group Description	A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. 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).		Usual treatment provided at the UNC OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
All Cause Mortality
	I-CAT		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)
Serious Adverse Events
	I-CAT		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/19 (15.8%)		2/19 (10.5%)
General disorders
Increased psychiatric symptoms	1/19 (5.3%)	1	2/19 (10.5%)	4
Discontinued medication	1/19 (5.3%)	1	0/19 (0%)	0
Dyskinesia	1/19 (5.3%)	1	0/19 (0%)	0
Other (Not Including Serious) Adverse Events
	I-CAT		Treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.