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

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Completed

Conditions

Schizophreniform Disorders

Treatments

Behavioral: Treatment as Usual
Behavioral: I-CAT

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03067311
4R33MH100250-03 (U.S. NIH Grant/Contract)
16-1173

Details and patient eligibility

About

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.

Full 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

Enrollment

38 patients

Sex

All

Ages

15 to 35 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

38 participants in 2 patient groups

I-CAT
Experimental group
Description:
A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians.
Treatment:
Behavioral: I-CAT
Treatment as Usual
Active Comparator group
Description:
Usual treatment provided at the University of North Carolina at Chapel Hill (UNC) Outreach and Support Intervention Services (OASIS) Clinic by trained clinicians.
Treatment:
Behavioral: Treatment as Usual

Trial documents
1

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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