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

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ClinicalTrials.gov Identifier: NCT03067311
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : May 25, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Schizophreniform Disorders Behavioral: I-CAT Behavioral: Treatment as Usual Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeting Stress Reactivity in Schizophrenia: Integrated Coping Awareness Therapy (I-CAT)
Actual Study Start Date : October 3, 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: I-CAT
A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians.
Behavioral: I-CAT
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).
Active Comparator: Treatment as Usual
Usual treatment provided at the UNC OASIS Clinics by trained clinicians.
Behavioral: Treatment as Usual
Treatment as usual defined by participant clinician at OASIS clinic.



Primary Outcome Measures :
  1. Change from Baseline Quality of Life Scale (QLS; Bilker et al., 2003) [ Time Frame: Baseline, 3.5 months, 7 months, 10 months ]
    The Quality of Life Scale (QLS) is a semi-structured 7-item interview with sub scales, including active acquaintances, social initiatives, occupational role functioning, degree of motivation, anhedonia, commonplace objects, and capacity for empathy. The 7-items are rated on a 7-point scale with higher ratings reflecting less impaired functioning.


Secondary Outcome Measures :
  1. Change in salivary cortisol [ Time Frame: Baseline,10 months ]

    A commercial enzyme-immuno assay will be used to measure cortisol in saliva to index hypothalamic-pituitary-adrenal activity at rest and in response to challenge (Salimetrics, State College, PA).

    salivary cortisol: micrograms/deciliter


  2. Change in urinary cortisol [ Time Frame: Baseline,10 months ]

    A commercial enzyme-immuno assay will be used to measure cortisol in urine to index hypothalamic-pituitary-adrenal activity at rest and in response to challenge (Salimetrics, State College, PA).

    urinary cortisol: micrograms cortisol/g creatinine


  3. Change in Heart rate variability (HRV) [ Time Frame: Baseline,10 months ]
    Each participant will be fitted with ECG electrodes to measure cardiac inter-beat interval (IBI) at 1000 Hz (Firstbeat Technologies). IBI data will be edited and analyzed for respiratory sinus arrhythmia (RSA) using CardioEdit and CardioBatch software. RSA will be used to quantify parasympathetic (vagal) activity.

  4. Change from Baseline Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Baseline, 3.5 months, 7 months, 10 months ]
    The presence and severity of psychosis related symptoms will be assessed using the Positive and Negative Syndrome Scale (PANSS). Items are rated on a 7-point scale and yield five scaled scores: positive symptoms, negative symptoms, dysphoric mood, activation, and autistic preoccupation.

  5. Change from Baseline Modified Differential Emotions Scale (mDES) Positive and Negative Emotion Total Score [ Time Frame: Baseline, 3.5 months, 7 months, 10 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.

  6. Change from Baseline Five Facet Mindfulness Questionnaire (FFMQ) Total Score [ Time Frame: Baseline, 3.5 months, 7 months, 10 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).

  7. Change from Baseline Psychological Well-Being (PWB) Scale Total Score [ Time Frame: Baseline, 3.5 months, 7 months, 10 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.

  8. Change physical Indices (weight) [ Time Frame: Baseline,10 months ]
    Change in weight in kg

  9. Changes in Daily Stress Scale total score [ Time Frame: Baseline,10 months ]
    The Daily Stress Inventory is a 58 item questionnaire which asks participants to rate a variety of events that may be viewed as stressful or unpleasant from the past 24 hours. All events are rated on a likert scale from 0 (did not occur in the past 24 hours) to 7 (cause me to panic). The questionnaire also has additional spaces for participants to write in any events that may have been stressful to them in the past 24 hours which were not listed.

  10. Changes in Daily Functioning Survey Total Score [ Time Frame: Throughout study therapy (Day 1 to 7 months) ]
    Daily Diary: Subjects will be asked to fill out an online daily diary over the course of the study which requests information about the subjects feelings, state of mind, social activity and techniques utilized from the therapy sessions

  11. Changes in Real-World Social Functioning total score [ Time Frame: Baseline, 3.5 months, 7 months, 10 months ]
    The First Episode Social Functioning Scale (FESFS) will be used to measure real world functional performance specifically for individuals with first episode schizophrenia. The 9-item scale includes domains referring to living skills, interactions with others, friends and activities, intimacy, family, relationships and social activities at work, work abilities, school relationships and social activities at school, and educational abilities.

  12. Changes in Self-Compassion total score [ Time Frame: Baseline, 3.5 months, 7 months, 10 months ]
    Short Self-Compassion Scale (Short SCS) will be used to measure changes in self-compassion in participants at all time points. The Short SCS is a 12 item questionnaire which assesses how participants usually act towards themselves in difficult times. The questionnaire uses a likert scale from 1 (almost never) to 5 (almost always).

  13. Changes in Resiliency total score [ Time Frame: Baseline, 3.5 months, 7 months, 10 months ]
    The Connor-Davidson Resilience Scale is a 10-item questionnaire that assesses subject's resiliency levels over the past month using a Likert scale from 0 "not true at all" to 4 "true nearly all of the time."

  14. Changes in Social Cognition (ER-40) total score [ Time Frame: Baseline, 7 months, 10 months ]
    The Emotion Recognition 40 (ER-40) is a standardized, computer administered measure of facial affect recognition ability. It includes 40 color photographs of faces expressing 4 basic emotions (i.e. happiness, sadness, anger or fear) and neutral expressions. Participants view one face at a time and are asked to choose the correct emotion for each face.

  15. Changes in Grit scale total score [ Time Frame: Baseline ]
    The Grit Scale is a 12-item questionnaire which assesses subject's perseverance, goal accomplishments, interests, and abilities; overall described as "grit." The questions fall on a Likert scale from "very much like me" to "not like me at all" where participants are asked to describe themselves, which no right or wrong answers established.

  16. Changes in Alcohol and Drug Use total score [ Time Frame: Baseline, 7 months, 10 months ]
    The Alcohol and Drug Use Scale (AUS/DUS) is a questionnaire which allows for the researcher to assess the subjects level of alcohol and drug use over the past month from 1 "abstinent" to 5 "dependence with institutionalization" and also the frequency of use of drugs/alcohol and cigarettes assessed separately.

  17. Changes in Social Cognition (Eyes) total score [ Time Frame: Baseline, 7 months, 10 months ]

    Reading the Mind in the Eyes Test (Eyes) measures the capacity to discriminate the mental state of others from expressions in the eye region of the face.

    Participants view 36 photos of the eye region of different faces and are asked to choose the most accurate descriptor word for the thought/feeling that is portrayed.


  18. changes in Loneliness total score [ Time Frame: Baseline, 3.5 months, 7 months ]
    UCLA Loneliness Scale: The UCLA Loneliness Scale is a 20-item questionnaire that assesses participant reported loneliness.

  19. Changes in therapeutic alliance [ Time Frame: 3.5 months and 7 months ]
    WAI- Client: The WAI (Working Alliance Inventory) is a questionnaire to be given to clients of the ICAT study to assess therapeutic alliance between therapist and client. This is a short 12-item survey that will be given to participants at study Mid-treatment and post-treatment and will also be used as a mediator variable.

  20. Changes in autonomy support [ Time Frame: 3.5 months and 7 months ]

    The Autonomy Support Measure is a short 6-item questionnaire requesting information about the extent to which the therapist provides an autonomous/supportive climate to the client. This is both an outcome and mediator variable.

    of their care.




Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • meets 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 OASIS, 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
  • IQ less than 80
  • meets criteria for current substance dependence
  • been hospitalized in the past month
  • actively practicing meditation in the past year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03067311


Contacts
Contact: David L Penn, PhD (919) 843-7514 dpenn@ad.unc.edu
Contact: Lana Nye, BS 919-962-4234 lnye@email.unc.edu

Locations
United States, North Carolina
UNC OASIS Carrboro Recruiting
Carrboro, North Carolina, United States, 27510
Contact: Diana Perkins, MD    919-962-1401    Diana_Perkins@med.unc.edu   
UNC STEP Recruiting
Carrboro, North Carolina, United States, 27510
Contact: Jason Wesson, MA, LCSW         
UNC Oasis Wake Recruiting
Raleigh, North Carolina, United States, 27603
Contact: Shay Alderman, LPC    919-445-0401    shay_alderman@med.unc.edu   
UNC Wake STEP Recruiting
Raleigh, North Carolina, United States, 27610
Contact: Shannon Wallace, LCSW         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: David L Penn, PhD The Unviersity of North Carolina at Chapel Hill
Principal Investigator: Diana Perkins, MD The Unviersity of North Carolina at Chapel Hill
Principal Investigator: Piper S Meyer-Kalos, PhD Minnesota Center for Chemical and Mental Health

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03067311     History of Changes
Other Study ID Numbers: 16-1173
4R33MH100250-03 ( U.S. NIH Grant/Contract )
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders