N/A
N=38
Targeting Stress Reactivity in Schizophrenia: Integrated Coping Awareness Therapy
Schizophreniform Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03067311 ↗Enrolled (actual)
38
Serious AEs
13.2%
Results posted
Mar 2021
Primary outcome: Primary: Change Over Time on the mDES - Positive — 0.35; 0.42; 0.62; 0.25 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- I-CAT (Behavioral); Treatment as Usual (Behavioral)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change Over Time on the mDES - Positive |
0.35; 0.42; 0.62; 0.25; 0.28; 0.38 | — |
| PRIMARY Change Over Time on the mDES - Negative |
0.01; -0.38; -0.27; -0.19; -0.01; -0.24 | — |
| PRIMARY Change Over Time on the QLS |
0.10; 0.36; 0.26; 0.28; 0.74; 0.91 | — |
| PRIMARY Change Over Time on the FESFS |
-0.07; 0.04; 0.22; 0.20; 0.40; 0.33 | — |
| PRIMARY Change Over Time on the PSS |
-0.26; -0.46; -0.36; -0.44; -0.16; -0.52 | — |
| PRIMARY Change Over Time on the DSI |
0.09; -0.09; 0.46; -0.12; -0.41; -0.51 | — |
| PRIMARY Change Over Time on Salivary Cortisol Levels |
0.0254; -0.0124 | — |
| SECONDARY Change Over Time on the PANSS Total Score |
-0.49; -0.29; -0.81; -0.29; -1.00; -0.66 | — |
| SECONDARY Change Over Time on the FFMQ |
0.18; 0.51; 0.35; 0.26; 0.26; 0.13 | — |
| SECONDARY Change Over Time on the SCS |
-0.06; 0.30; 0.11; 0.27; 0.04; 0.13 | — |
| SECONDARY Change Over Time on the PWB |
0.21; 0.17; 0.36; -0.01; 0.29; 0.12 | — |
| SECONDARY Respiratory Sinus Arrhythmia |
4.58; 6.15 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03067311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.