Clinical trial NCT03067311: Targeting Stress Reactivity in Schizophrenia: Integrated Coping Awareness Therapy
Official title: Targeting Stress Reactivity in Schizophrenia: Integrated Coping Awareness Therapy (I-CAT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophreniform Disorders
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-03-01
Enrollment: 38
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change Over Time on the mDES - Positive
timeFrame: Baseline, 4.5, 9, and 12 months
measure: Change Over Time on the mDES - Negative
timeFrame: Baseline, 4.5, 9, and 12 months
measure: Change Over Time on the QLS
timeFrame: Baseline, 4.5, 9, and 12 months
measure: Change Over Time on the FESFS
timeFrame: Baseline, 4.5, 9, and 12 months
measure: Change Over Time on the PSS
timeFrame: Baseline, 4.5, 9, and 12 months
measure: Change Over Time on the DSI
timeFrame: Baseline, 4.5, 9, and 12 months
measure: Change Over Time on Salivary Cortisol Levels
timeFrame: Baseline, 9 months
Secondary outcomes:
measure: Change Over Time on the PANSS Total Score
timeFrame: Baseline, 4.5, 9, and 12 months
measure: Change Over Time on the FFMQ
timeFrame: Baseline, 4.5, 9, and 12 months
measure: Change Over Time on the SCS
timeFrame: Baseline, 4.5, 9, and 12 months
measure: Change Over Time on the PWB
timeFrame: Baseline, 4.5, 9, and 12 months
measure: Respiratory Sinus Arrhythmia
timeFrame: 9 months
Other outcomes:
Locations:
city: Carrboro
country: United States
facility: UNC OASIS Carrboro
state: North Carolina
city: Carrboro
country: United States
facility: UNC STEP
state: North Carolina
city: Raleigh
country: United States
facility: UNC Oasis Wake
state: North Carolina
city: Raleigh
country: United States
facility: UNC Wake STEP
state: North Carolina
Study officials:
affiliation: The Unviersity of North Carolina at Chapel Hill
name: David L Penn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Unviersity of North Carolina at Chapel Hill
name: Diana Perkins, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Minnesota Center for Chemical and Mental Health
name: Piper S Meyer-Kalos, PhD
role: PRINCIPAL_INVESTIGATOR
References: