Integrated Coping and Awareness Training (I-CAT)

Targeting Stress Reactivity in Schizophrenia: Integrating Coping Awareness Therapy (I-CAT) Pilot Trial

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).

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: I-CAT Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Salivary Cortisol at Six Months	Salivary cortisol measured before, during and after a social stressor test.	Baseline, 6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Urinary Oxidative Stress Level [Isoprostane] at Six Months		Baseline, 6 Months
Change from Baseline Positive and Negative Syndrome Scale (PANSS) Total Score at Six Months	The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (no current symptomatology) to 210 (severely ill).	Baseline, 6 Months
Change from Baseline Quality of Life Scale (QLS; Bilker et al., 2003) Total Score at Six Months	The Quality of Life Scale (QLS) is a semi-structured interview with 7-items that are rated on a 7-point scale with higher ratings reflecting less impaired functioning.	Baseline, 6 Months
Change from Baseline Heart Rate Variability (HRV) Measurement at Six Months		Baseline, 6 Months
Change from Baseline Modified Differential Emotions Scale (mDES) Positive Emotion Sub Scale Score at Six Months	Rating scale that identifies strongest experiences of 20 emotions for the past week on a 5-point scale from (0 = not at all to 4= extremely). The mDES includes a Positive and Negative Emotion subscale.	Baseline, 6 Months
Change from Baseline Perceived Stress Scale (PSS) Total Score at Six Months	The PSS is a 10-item, well validated and widely used self-report measure of the degree that situations in day-to-day life are perceived as stressful, unpredictable, uncontrollable, and how overloaded subjects find their lives. The 10 items are rated on a 5-point scale that ranges from 0 (never) to 4 (almost always). The PSS total score consists of the sum of the 10 PSS items and ranges from 0 (no subjective experience of stress) to 40 (overwhelmed with stress).	Baseline, 6 Months
Change from Baseline Brief COPE Scale (Assisted Format) Total Score at Six Months	A short-version COPE Inventory. Assesses response to stress. 14 scales with two items each; self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion and self-blame. Reliability analyses exceeded alpha=0.60, except for venting, denial and acceptance, all of which exceed alpha = 0.50 (Carver et al 1997) Carver, C. S. (1997). International Journal of Behavioral Medicine, 4, 92-100	Baseline, 6 Months
Change from Baseline Five Facet Mindfulness Questionnaire (FFMQ) Total Score at Six Months	The Five Facet Mindfulness Questionnaire (FFMQ) which assesses the five facets of being mindful in daily life: observing, describing, acting with awareness, non-reactivity to inner experience, and non- judging of inner experience. Each of the 39 items is rated using a Likert-type scale ranging from 1 (never or very rarely true) to 5 (very often or always true).	Baseline, 6 Months
Change from Baseline Psychological Well-Being (PWB) Scale Total Score at Six Months	The Psychological Well-Being (PWB) Scale includes six sub scales (autonomy, environmental mastery, personal growth, purpose in life, positive relations with others, and self-acceptance) as well as a total score. The 54 items are rated on a 7-point Likert scale from 1 "strongly disagree" to 7 "strongly agree", with some items being reverse-scored.	Baseline, 6 Months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Diana O Perkins, MD, MPH, University of North Carolina, Chapel Hill; Principal Investigator: Piper Meyer-Kalos, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 17, 2015
• First Submitted That Met QC Criteria: March 23, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Estimate): April 8, 2016
• Last Update Submitted That Met QC Criteria: April 7, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Treatment; Schizophrenia; Mindfulness; Meditation; Coping; First Episode Psychosis; Stress reactivity
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 14-1815; R21MH100250 (U.S. NIH Grant/Contract)