Integrated Coping and Awareness Training

NCT ID: NCT02400502

Last Updated: 2016-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-04-30

Brief Summary

Integrated Coping and Awareness Therapy is a novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping, as well as a range of possible proximal (e.g. immune indices of stress reactivity, symptom severity) and distal measures (e.g. relapse, quality of life).

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

I-CAT Therapy

Integrated Coping and Awareness Therapy is a six-month intervention designed to examine the physiological, biological, and psychological effects of meditation and mindfulness practice on individuals diagnosed with a psychotic disorder.

Group Type: EXPERIMENTAL

I-CAT Therapy

Intervention Type: BEHAVIORAL

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). Participants meet weekly with a master's level clinician over the course of 20 weeks.

Interventions

I-CAT Therapy

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). Participants meet weekly with a master's level clinician over the course of 20 weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Current or past diagnosis of a schizophrenia spectrum disorder.
• Has been receiving treatment for psychosis or taking medication for psychosis for less than 5 years.

Exclusion Criteria

• Has been hospitalized in the last 3 months.
• Currently practicing meditation
• Current dependence on alcohol or drugs.
• History of significant neurological disorder.
• History of serious head injury (i.e., loss of consciousness longer than 15 minutes, no neuropsychological sequelae, no cognitive rehabilitation treatment post head injury).
• Illiteracy.
• Sensory limitation including visual (e.g., blindness, glaucoma, vision uncorrectable to 20/40) or hearing (e.g. hearing loss) impairments.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diana O Perkins, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

David L Penn, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Piper Meyer-Kalos, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

R21MH100250

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-1815

Identifier Type: -

Identifier Source: org_study_id