Trial Outcomes & Findings for Targeting Stress Reactivity in Schizophrenia: Integrated Coping Awareness Therapy (NCT NCT03067311)
NCT ID: NCT03067311
Last Updated: 2021-03-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
Baseline, 4.5, 9, and 12 months
Results posted on
2021-03-03
Participant Flow
Participant milestones
| Measure |
I-CAT
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).
|
Treatment as Usual
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
17
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
I-CAT
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).
|
Treatment as Usual
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Moved away
|
1
|
1
|
Baseline Characteristics
Targeting Stress Reactivity in Schizophrenia: Integrated Coping Awareness Therapy
Baseline characteristics by cohort
| Measure |
I-CAT
n=19 Participants
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).
|
Treatment as Usual
n=19 Participants
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
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
23.6 years
STANDARD_DEVIATION 4.3 • n=93 Participants
|
24.9 years
STANDARD_DEVIATION 3.9 • n=4 Participants
|
24.3 years
STANDARD_DEVIATION 4.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
WASI-II Intelligence Quotient (IQ) Score
|
107.7 t-score
STANDARD_DEVIATION 14.1 • n=93 Participants
|
111.5 t-score
STANDARD_DEVIATION 12 • n=4 Participants
|
109.6 t-score
STANDARD_DEVIATION 13.05 • n=27 Participants
|
|
Duration of Illness
|
1.7 years
STANDARD_DEVIATION 1.5 • n=93 Participants
|
1.8 years
STANDARD_DEVIATION 2 • n=4 Participants
|
1.8 years
STANDARD_DEVIATION 1.8 • n=27 Participants
|
|
PANSS Total
|
62.3 units on a scale
STANDARD_DEVIATION 17.2 • n=93 Participants
|
58.4 units on a scale
STANDARD_DEVIATION 16 • n=4 Participants
|
60.4 units on a scale
STANDARD_DEVIATION 16.6 • n=27 Participants
|
|
mDES - Positive Emotions
|
21.3 units on a scale
STANDARD_DEVIATION 6.9 • n=93 Participants
|
20.9 units on a scale
STANDARD_DEVIATION 9.3 • n=4 Participants
|
21.1 units on a scale
STANDARD_DEVIATION 8.1 • n=27 Participants
|
|
mDES - Negative Emotions
|
15.6 units on a scale
STANDARD_DEVIATION 8.7 • n=93 Participants
|
18.2 units on a scale
STANDARD_DEVIATION 10.6 • n=4 Participants
|
16.9 units on a scale
STANDARD_DEVIATION 9.65 • n=27 Participants
|
|
Quality of Life Scale
|
26 units on a scale
STANDARD_DEVIATION 8.3 • n=93 Participants
|
25.3 units on a scale
STANDARD_DEVIATION 7.2 • n=4 Participants
|
25.7 units on a scale
STANDARD_DEVIATION 7.8 • n=27 Participants
|
|
First Episode Social Functioning Scale
|
3 units on a scale
STANDARD_DEVIATION 0.4 • n=93 Participants
|
3.2 units on a scale
STANDARD_DEVIATION 0.5 • n=4 Participants
|
3.1 units on a scale
STANDARD_DEVIATION 0.45 • n=27 Participants
|
|
Perceived Stress Scale
|
18.8 units on a scale
STANDARD_DEVIATION 6.3 • n=93 Participants
|
20.9 units on a scale
STANDARD_DEVIATION 8.5 • n=4 Participants
|
19.9 units on a scale
STANDARD_DEVIATION 7.4 • n=27 Participants
|
|
Daily Stress Inventory
|
3.0 units on a scale
STANDARD_DEVIATION 1.3 • n=93 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 1.2 • n=4 Participants
|
2.95 units on a scale
STANDARD_DEVIATION 1.25 • n=27 Participants
|
|
Five Facets of Mindfulness Questionnaire
|
3 units on a scale
STANDARD_DEVIATION 0.4 • n=93 Participants
|
3 units on a scale
STANDARD_DEVIATION 0.6 • n=4 Participants
|
3 units on a scale
STANDARD_DEVIATION 0.5 • n=27 Participants
|
|
Self-Compassion Scale
|
34.7 units on a scale
STANDARD_DEVIATION 7 • n=93 Participants
|
35.7 units on a scale
STANDARD_DEVIATION 9.7 • n=4 Participants
|
35.2 units on a scale
STANDARD_DEVIATION 8.35 • n=27 Participants
|
|
Perceived Well-Being Scale
|
207.9 units on a scale
STANDARD_DEVIATION 36.8 • n=93 Participants
|
209.32 units on a scale
STANDARD_DEVIATION 46.8 • n=4 Participants
|
208.61 units on a scale
STANDARD_DEVIATION 41.8 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4.5, 9, and 12 monthsThe 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.
Outcome measures
| Measure |
I-CAT
n=17 Participants
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).
|
Treatment as Usual
n=17 Participants
Usual treatment provided at the UNC OASIS Clinics by trained clinicians.
Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
|
|---|---|---|
|
Change Over Time on the mDES - Positive
4.5 months change from baseline
|
0.35 units on a scale
Standard Error 0.19
|
0.42 units on a scale
Standard Error 0.20
|
|
Change Over Time on the mDES - Positive
9 months change from baseline
|
0.62 units on a scale
Standard Error 0.19
|
0.25 units on a scale
Standard Error 0.19
|
|
Change Over Time on the mDES - Positive
12 months change from baseline
|
0.28 units on a scale
Standard Error 0.19
|
0.38 units on a scale
Standard Error 0.21
|
PRIMARY outcome
Timeframe: Baseline, 4.5, 9, and 12 monthsThe 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.
Outcome measures
| Measure |
I-CAT
n=17 Participants
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).
|
Treatment as Usual
n=17 Participants
Usual treatment provided at the UNC OASIS Clinics by trained clinicians.
Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
|
|---|---|---|
|
Change Over Time on the mDES - Negative
4.5 months change from baseline
|
0.01 units on a scale
Standard Error 0.17
|
-0.38 units on a scale
Standard Error 0.20
|
|
Change Over Time on the mDES - Negative
9 months change from baseline
|
-0.27 units on a scale
Standard Error 0.17
|
-0.19 units on a scale
Standard Error 0.19
|
|
Change Over Time on the mDES - Negative
12 months change from baseline
|
-0.01 units on a scale
Standard Error 0.19
|
-0.24 units on a scale
Standard Error 0.20
|
PRIMARY outcome
Timeframe: Baseline, 4.5, 9, and 12 monthsThe 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.
Outcome measures
| Measure |
I-CAT
n=17 Participants
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).
|
Treatment as Usual
n=17 Participants
Usual treatment provided at the UNC OASIS Clinics by trained clinicians.
Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
|
|---|---|---|
|
Change Over Time on the QLS
4.5 months change from baseline
|
0.10 units on a scale
Standard Error 0.16
|
0.36 units on a scale
Standard Error 0.78
|
|
Change Over Time on the QLS
9 months change from baseline
|
0.26 units on a scale
Standard Error 0.16
|
0.28 units on a scale
Standard Error 0.18
|
|
Change Over Time on the QLS
12 months change from baseline
|
0.74 units on a scale
Standard Error 0.16
|
0.91 units on a scale
Standard Error 0.18
|
PRIMARY outcome
Timeframe: Baseline, 4.5, 9, and 12 monthsThe 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.
Outcome measures
| Measure |
I-CAT
n=17 Participants
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).
|
Treatment as Usual
n=17 Participants
Usual treatment provided at the UNC OASIS Clinics by trained clinicians.
Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
|
|---|---|---|
|
Change Over Time on the FESFS
4.5 months change from baseline
|
-0.07 units on a scale
Standard Error 0.14
|
0.04 units on a scale
Standard Error 0.16
|
|
Change Over Time on the FESFS
9 months change from baseline
|
0.22 units on a scale
Standard Error 0.15
|
0.20 units on a scale
Standard Error 0.15
|
|
Change Over Time on the FESFS
12 months change from baseline
|
0.40 units on a scale
Standard Error 0.15
|
0.33 units on a scale
Standard Error 0.17
|
PRIMARY outcome
Timeframe: Baseline, 4.5, 9, and 12 monthsThe 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.
Outcome measures
| Measure |
I-CAT
n=17 Participants
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).
|
Treatment as Usual
n=17 Participants
Usual treatment provided at the UNC OASIS Clinics by trained clinicians.
Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
|
|---|---|---|
|
Change Over Time on the PSS
4.5 months change from baseline
|
-0.26 units on a scale
Standard Error 0.19
|
-0.46 units on a scale
Standard Error 0.23
|
|
Change Over Time on the PSS
9 months change from baseline
|
-0.36 units on a scale
Standard Error 0.19
|
-0.44 units on a scale
Standard Error 0.20
|
|
Change Over Time on the PSS
12 months change from baseline
|
-0.16 units on a scale
Standard Error 0.20
|
-0.52 units on a scale
Standard Error 0.22
|
PRIMARY outcome
Timeframe: Baseline, 4.5, 9, and 12 monthsThe 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.
Outcome measures
| Measure |
I-CAT
n=17 Participants
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).
|
Treatment as Usual
n=17 Participants
Usual treatment provided at the UNC OASIS Clinics by trained clinicians.
Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
|
|---|---|---|
|
Change Over Time on the DSI
4.5 months change from baseline
|
0.09 units on a scale
Standard Error 0.23
|
-0.09 units on a scale
Standard Error 0.23
|
|
Change Over Time on the DSI
9 months change from baseline
|
0.46 units on a scale
Standard Error 0.22
|
-0.12 units on a scale
Standard Error 0.23
|
|
Change Over Time on the DSI
12 months change from baseline
|
-0.41 units on a scale
Standard Error 0.24
|
-0.51 units on a scale
Standard Error 0.25
|
PRIMARY outcome
Timeframe: Baseline, 9 monthsPopulation: Saliva samples unable to be collected from all participants.
Salivary cortisol levels were collected as a measure of psychological stress.
Outcome measures
| Measure |
I-CAT
n=17 Participants
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).
|
Treatment as Usual
n=12 Participants
Usual treatment provided at the UNC OASIS Clinics by trained clinicians.
Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
|
|---|---|---|
|
Change Over Time on Salivary Cortisol Levels
|
0.0254 ug/dL
Standard Error 0.0240
|
-0.0124 ug/dL
Standard Error 0.0274
|
SECONDARY outcome
Timeframe: Baseline, 4.5, 9, and 12 monthsThe 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.
Outcome measures
| Measure |
I-CAT
n=17 Participants
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).
|
Treatment as Usual
n=17 Participants
Usual treatment provided at the UNC OASIS Clinics by trained clinicians.
Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
|
|---|---|---|
|
Change Over Time on the PANSS Total Score
4.5 months change from baseline
|
-0.49 units on a scale
Standard Error 0.15
|
-0.29 units on a scale
Standard Error 0.16
|
|
Change Over Time on the PANSS Total Score
9 months change from baseline
|
-0.81 units on a scale
Standard Error 0.15
|
-0.29 units on a scale
Standard Error 0.16
|
|
Change Over Time on the PANSS Total Score
12 months change from baseline
|
-1.00 units on a scale
Standard Error 0.15
|
-0.66 units on a scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: Baseline, 4.5, 9, and 12 monthsThe 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.
Outcome measures
| Measure |
I-CAT
n=17 Participants
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).
|
Treatment as Usual
n=17 Participants
Usual treatment provided at the UNC OASIS Clinics by trained clinicians.
Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
|
|---|---|---|
|
Change Over Time on the FFMQ
4.5 months change from baseline
|
0.18 units on a scale
Standard Error 0.144
|
0.51 units on a scale
Standard Error 0.15
|
|
Change Over Time on the FFMQ
9 months change from baseline
|
0.35 units on a scale
Standard Error 0.14
|
0.26 units on a scale
Standard Error 0.14
|
|
Change Over Time on the FFMQ
12 months change from baseline
|
0.26 units on a scale
Standard Error 0.14
|
0.13 units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Baseline, 4.5, 9, and 12 monthsThe 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.
Outcome measures
| Measure |
I-CAT
n=17 Participants
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).
|
Treatment as Usual
n=17 Participants
Usual treatment provided at the UNC OASIS Clinics by trained clinicians.
Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
|
|---|---|---|
|
Change Over Time on the SCS
4.5 months change from baseline
|
-0.06 units on a scale
Standard Error 0.18
|
0.30 units on a scale
Standard Error 0.20
|
|
Change Over Time on the SCS
9 months change from baseline
|
0.11 units on a scale
Standard Error 0.18
|
0.27 units on a scale
Standard Error 0.19
|
|
Change Over Time on the SCS
12 months change from baseline
|
0.04 units on a scale
Standard Error 0.19
|
0.13 units on a scale
Standard Error 0.20
|
SECONDARY outcome
Timeframe: Baseline, 4.5, 9, and 12 monthsThe 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.
Outcome measures
| Measure |
I-CAT
n=17 Participants
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).
|
Treatment as Usual
n=17 Participants
Usual treatment provided at the UNC OASIS Clinics by trained clinicians.
Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
|
|---|---|---|
|
Change Over Time on the PWB
4.5 months change from baseline
|
0.21 units on a scale
Standard Error 0.14
|
0.17 units on a scale
Standard Error 0.15
|
|
Change Over Time on the PWB
9 months change from baseline
|
0.36 units on a scale
Standard Error 0.14
|
-0.01 units on a scale
Standard Error 0.15
|
|
Change Over Time on the PWB
12 months change from baseline
|
0.29 units on a scale
Standard Error 0.14
|
0.12 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: 9 monthsPopulation: Data not available for all participants due to device technical issues or post-treatment appointment completed remotely.
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.
Outcome measures
| Measure |
I-CAT
n=9 Participants
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).
|
Treatment as Usual
n=11 Participants
Usual treatment provided at the UNC OASIS Clinics by trained clinicians.
Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
|
|---|---|---|
|
Respiratory Sinus Arrhythmia
|
4.58 ln(msec)^2
Standard Error 0.520
|
6.15 ln(msec)^2
Standard Error 0.562
|
Adverse Events
I-CAT
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
I-CAT
n=19 participants at risk
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).
|
Treatment as Usual
n=19 participants at risk
Usual treatment provided at the UNC OASIS Clinics by trained clinicians.
Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.
|
|---|---|---|
|
General disorders
Increased psychiatric symptoms
|
5.3%
1/19 • Number of events 1 • From baseline to study follow-up, a total of approximately 12 months.
|
10.5%
2/19 • Number of events 4 • From baseline to study follow-up, a total of approximately 12 months.
|
|
General disorders
Discontinued medication
|
5.3%
1/19 • Number of events 1 • From baseline to study follow-up, a total of approximately 12 months.
|
0.00%
0/19 • From baseline to study follow-up, a total of approximately 12 months.
|
|
General disorders
Dyskinesia
|
5.3%
1/19 • Number of events 1 • From baseline to study follow-up, a total of approximately 12 months.
|
0.00%
0/19 • From baseline to study follow-up, a total of approximately 12 months.
|
Other adverse events
Adverse event data not reported
Additional Information
David Penn, PhD
University of North Carolina at Chapel Hill
Phone: (919) 843-7514
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place