Targeting Stress Reactivity in Schizophrenia: Integrated Coping Awareness Therapy

NCT03067311 | Completed Results

• 2 other identifiers: 16-11734R33MH100250-03
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 4

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.

Conditions

Schizophreniform Disorders

Outcome Measures

Primary Outcomes (7)

• Change Over Time on the mDES - Positive

  The modified self-report Differential Emotion Scale (mDES) assessed the frequency of experiencing discrete emotions from the previous week. Items are endorsed on a five-point scale indicating frequency (0 = not at all, 4 = most of the time). Items are summed to yield positive (mDES - Positive) and negative emotion (mDES - Negative) subscales (range for both 0-40). Higher scores on the positive subscale indicate more positive emotions. Assessed at 4.5 months, 9 months, 12 months.

  Baseline, 4.5, 9, and 12 months

• Change Over Time on the mDES - Negative

  The modified self-report Differential Emotion Scale (mDES) assessed the frequency of experiencing discrete emotions from the previous week. Items are endorsed on a five-point scale indicating frequency (0 = not at all, 4 = most of the time). Items are summed to yield positive (mDES - Positive) and negative emotion (mDES - Negative) subscales (range for both 0-40). Higher scores on the negative subscale indicate more negative emotions. Assessed at 4.5 months, 9 months, 12 months.

  Baseline, 4.5, 9, and 12 months

• Change Over Time on the QLS

  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 (total range 7-49). Assessed at 4.5 months, 9 months, 12 months.

  Baseline, 4.5, 9, and 12 months

• Change Over Time on the FESFS

  The First Episode Social Functioning Scale (FESFS) is a 42-item self-report measure assessing social functioning in early SSD. The FESFS includes a total score and eight subscales assessing: independent living skills, interacting with people in different contexts, social activities, intimacy, friendships, family relations, work, and school. Domain scores are averaged with higher scores reflecting better perceived functioning (range 0-4). Assessed at 4.5 months, 9 months, 12 months.

  Baseline, 4.5, 9, and 12 months

• Change Over Time on the PSS

  The Perceived Stress Scale (PSS) is a ten-item self-report measure of the degree to which daily situations from the past week are perceived as stressful, unpredictable, uncontrollable, as well as how "overloaded" individuals feel (0 = never, 4 = very often). Items are summed for a total score (range 0 - 40) with higher scores indicating more perceived stress. Assessed at 4.5 months, 9 months, 12 months.

  Baseline, 4.5, 9, and 12 months

• Change Over Time on the DSI

  The Daily Stress Inventory (DSI) is a 58-item self-report measure assessing the frequency and intensity of stressful events within the past 24-hours. If an event is endorsed, participants rate the amount of stress the event caused (0 = did not occur, 1 = occurred but was not stressful to 7 = occurred and caused me to panic). The DSI yields an average impact rating (AIR; average impact of ratings given items endorsed \[sum/frequency\]; range 1-7) with higher scores indicating more daily stress. Assessed at 4.5 months, 9 months, 12 months.

  Baseline, 4.5, 9, and 12 months

• Change Over Time on Salivary Cortisol Levels

  Salivary cortisol levels were collected as a measure of psychological stress.

  Baseline, 9 months

Secondary Outcomes (5)

• Change Over Time on the PANSS Total Score

  Baseline, 4.5, 9, and 12 months

• Change Over Time on the FFMQ

  Baseline, 4.5, 9, and 12 months

• Change Over Time on the SCS

  Baseline, 4.5, 9, and 12 months

• Change Over Time on the PWB

  Baseline, 4.5, 9, and 12 months

• Respiratory Sinus Arrhythmia

  9 months

Study Arms (2)

I-CAT

EXPERIMENTAL

A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians.

Behavioral: I-CAT

Treatment as Usual

ACTIVE COMPARATOR

Usual treatment provided at the University of North Carolina at Chapel Hill (UNC) Outreach and Support Intervention Services (OASIS) Clinic by trained clinicians.

Behavioral: Treatment as Usual

Interventions

I-CAT 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).

I-CAT

Treatment as Usual BEHAVIORAL

Treatment as usual defined by participant clinician at OASIS clinic.

Treatment as Usual

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

UNC OASIS Carrboro

Carrboro, North Carolina, 27510, United States

Location

UNC STEP

Carrboro, North Carolina, 27510, United States

Location

UNC Oasis Wake

Raleigh, North Carolina, 27603, United States

Location

UNC Wake STEP

Raleigh, North Carolina, 27610, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: David Penn, PhD
• Organization: University of North Carolina at Chapel Hill

dpenn@email.unc.edu

(919) 843-7514

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 1, 2017
• Study Start: October 3, 2016
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: March 3, 2021
• Results First Posted: March 3, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)