Targeting Stress Reactivity in Schizophrenia: Integrated Coping Awareness Therapy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03067311

Acronym

I-CAT

Enrollment

Registered

2017-03-01

Start date

2016-10-03

Completion date

2020-03-30

Last updated

2021-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophreniform Disorders

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

Interventions

BEHAVIORALI-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).

BEHAVIORALTreatment as Usual

Treatment as usual defined by participant clinician at OASIS clinic.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

15 Years to 35 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.
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.
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.
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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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).	19
Treatment as Usual Usual treatment provided at the UNC OASIS Clinics by trained clinicians. Treatment as Usual: Treatment as usual defined by participant clinician at OASIS clinic.	19
Total	38

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	1
Overall Study	Moved away	1	1

Baseline characteristics

Characteristic	I-CAT	Treatment as Usual	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	19 Participants	19 Participants	38 Participants
Age, Continuous	23.6 years STANDARD_DEVIATION 4.3	24.9 years STANDARD_DEVIATION 3.9	24.3 years STANDARD_DEVIATION 4.1
Daily Stress Inventory	3.0 units on a scale STANDARD_DEVIATION 1.3	2.9 units on a scale STANDARD_DEVIATION 1.2	2.95 units on a scale STANDARD_DEVIATION 1.25
Duration of Illness	1.7 years STANDARD_DEVIATION 1.5	1.8 years STANDARD_DEVIATION 2	1.8 years STANDARD_DEVIATION 1.8
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants	1 Participants	5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants	18 Participants	33 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
First Episode Social Functioning Scale	3 units on a scale STANDARD_DEVIATION 0.4	3.2 units on a scale STANDARD_DEVIATION 0.5	3.1 units on a scale STANDARD_DEVIATION 0.45
Five Facets of Mindfulness Questionnaire	3 units on a scale STANDARD_DEVIATION 0.4	3 units on a scale STANDARD_DEVIATION 0.6	3 units on a scale STANDARD_DEVIATION 0.5
mDES - Negative Emotions	15.6 units on a scale STANDARD_DEVIATION 8.7	18.2 units on a scale STANDARD_DEVIATION 10.6	16.9 units on a scale STANDARD_DEVIATION 9.65
mDES - Positive Emotions	21.3 units on a scale STANDARD_DEVIATION 6.9	20.9 units on a scale STANDARD_DEVIATION 9.3	21.1 units on a scale STANDARD_DEVIATION 8.1
PANSS Total	62.3 units on a scale STANDARD_DEVIATION 17.2	58.4 units on a scale STANDARD_DEVIATION 16	60.4 units on a scale STANDARD_DEVIATION 16.6
Perceived Stress Scale	18.8 units on a scale STANDARD_DEVIATION 6.3	20.9 units on a scale STANDARD_DEVIATION 8.5	19.9 units on a scale STANDARD_DEVIATION 7.4
Perceived Well-Being Scale	207.9 units on a scale STANDARD_DEVIATION 36.8	209.32 units on a scale STANDARD_DEVIATION 46.8	208.61 units on a scale STANDARD_DEVIATION 41.8
Quality of Life Scale	26 units on a scale STANDARD_DEVIATION 8.3	25.3 units on a scale STANDARD_DEVIATION 7.2	25.7 units on a scale STANDARD_DEVIATION 7.8
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	1 Participants	2 Participants
Race (NIH/OMB) Asian	2 Participants	2 Participants	4 Participants
Race (NIH/OMB) Black or African American	5 Participants	2 Participants	7 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	11 Participants	14 Participants	25 Participants
Region of Enrollment United States	19 Participants	19 Participants	38 Participants
Self-Compassion Scale	34.7 units on a scale STANDARD_DEVIATION 7	35.7 units on a scale STANDARD_DEVIATION 9.7	35.2 units on a scale STANDARD_DEVIATION 8.35
Sex: Female, Male Female	9 Participants	9 Participants	18 Participants
Sex: Female, Male Male	10 Participants	10 Participants	20 Participants
WASI-II Intelligence Quotient (IQ) Score	107.7 t-score STANDARD_DEVIATION 14.1	111.5 t-score STANDARD_DEVIATION 12	109.6 t-score STANDARD_DEVIATION 13.05

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 19	0 / 19
other Total, other adverse events	0 / 19	0 / 19
serious Total, serious adverse events	3 / 19	2 / 19

Outcome results

Primary

Change Over Time on Salivary Cortisol Levels

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

Time frame: Baseline, 9 months

Population: Saliva samples unable to be collected from all participants.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
I-CAT	Change Over Time on Salivary Cortisol Levels	0.0254 ug/dL	Standard Error 0.024
Treatment as Usual	Change Over Time on Salivary Cortisol Levels	-0.0124 ug/dL	Standard Error 0.0274

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.