Schizophreniform DisordersI-CATNCT03067311
Targeting Stress Reactivity in Schizophrenia: Integrated Coping Awareness Therapy
A study testing I-CAT and Treatment as Usual in people with Schizophreniform Disorders, run by University of North Carolina, Chapel Hill at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Schizophreniform Disorders
- What is being tested?
- I-CAT and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Oct 2016to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
UNC OASIS Carrboro
Carrboro, North Carolina, 27510
UNC STEP
Carrboro, North Carolina, 27510
UNC Oasis Wake
Raleigh, North Carolina, 27603
UNC Wake STEP
Raleigh, North Carolina, 27610
About this study
Official title: Targeting Stress Reactivity in Schizophrenia: Integrated Coping Awareness Therapy (I-CAT)
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.
Read the 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
- Schizophreniform Disorders
- Being tested
- I-CAT, Treatment as Usual
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-CATBehavioural
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).
Treatment as UsualBehavioural
Treatment as usual defined by participant clinician at OASIS clinic.
| Study group | Role | What they receive |
|---|---|---|
| I-CAT | Experimental | A novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. Receives: 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. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 9 months
Secondary outcomes (5)
Change Over Time on the PANSS Total Score
The Positive and Negative Syndrome Scale (PANSS) assessed current symptoms. PANSS items are rated on a seven-point scale with higher scores reflecting more severe symptoms (ICCs for study assessors >.90). Items are summed for a total score (range 30 - 210). Assessed at 4.5 months, 9 months, 12 months.
Measured: Baseline, 4.5, 9, and 12 months
Change Over Time on the FFMQ
The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item self-report measure assessing facets of being mindful in daily life (i.e., observing, describing, acting with awareness, non-reactivity to inner experience, and non-judging of inner experience). Items are endorsed on a five-point scale (1 = never or rarely true to 5 = very often or always true) and averaged for a total score (range 1-5) with higher scores indicating greater mindfulness ability. Assessed at 4.5 months, 9 months, 12 months.
Measured: Baseline, 4.5, 9, and 12 months
Change Over Time on the SCS
The Self-Compassion Scale Short Form (SCS) is a 12-item self-report measure of self-compassion. SCS items are endorsed on a five-point scale (1 = almost never to 5 = almost always) and are summed for a total score (range 12 - 60) with higher scores indicating higher levels of self-compassion. Assessed at 4.5 months, 9 months, 12 months.
Measured: Baseline, 4.5, 9, and 12 months
Change Over Time on the PWB
The Psychological Well-Being Scale (PWB) is a 54-item self-report measure with items endorsed on a seven-point scale (1 = strongly disagree to 6 = strongly agree). Items are summed for a total score (range 54 - 324) with higher scores indicating better psychological well-being. Assessed at 4.5 months, 9 months, 12 months.
Measured: Baseline, 4.5, 9, and 12 months
Respiratory Sinus Arrhythmia
Index of heart rate variability assessed as the ratio of low-to-high frequencies in the respiratory-cardiac power spectrum. Mean level respiratory sinus arrhythmia (RSA) derived from heart rate monitor worn while participants engaged in a 5-minute mindfulness exercise.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start3 Oct 2016
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Schizophreniform DisordersStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- David L Penn, PhD, Principal investigator, The Unviersity of North Carolina at Chapel HillDiana Perkins, MD, Principal investigator, The Unviersity of North Carolina at Chapel HillPiper S Meyer-Kalos, PhD, Principal investigator, Minnesota Center for Chemical and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067311
- Sponsor's protocol ID
- 16-1173
- Other IDs
- 4R33MH100250-03
- Acronym
- I-CAT
- Status last verified
- May 2020
- First submitted
- 16 Feb 2017
- Last updated
- 3 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Stress Reactivity in Schizophrenia: Integrated Coping Awareness Therapy (I-CAT)
- ClinicalTrials.gov ID
- NCT03067311
- Acronym / sponsor ID
- I-CAT / 16-1173
- Conditions
- Schizophreniform Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Posted 3 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-CAT | Experimental | Behavioral: I-CATA novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping given by trained clinicians. |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualUsual treatment provided at the University of North Carolina at Chapel Hill (UNC) Outreach and Support Intervention Services (OASIS) Clinic by trained clinicians. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-CATI-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). | Behavioural | I-CAT |
| Treatment as UsualTreatment as usual defined by participant clinician at OASIS clinic. | Behavioural | Treatment as Usual |
Primary outcome
Change Over Time on the mDES - Positive
Time frame: Baseline, 4.5, 9, and 12 months
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.
Change Over Time on the mDES - Negative
Time frame: Baseline, 4.5, 9, and 12 months
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.
Change Over Time on the QLS
Time frame: Baseline, 4.5, 9, and 12 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 (total range 7-49). Assessed at 4.5 months, 9 months, 12 months.
Change Over Time on the FESFS
Time frame: Baseline, 4.5, 9, and 12 months
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.
Change Over Time on the PSS
Time frame: Baseline, 4.5, 9, and 12 months
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.
Change Over Time on the DSI
Time frame: Baseline, 4.5, 9, and 12 months
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.
Change Over Time on Salivary Cortisol Levels
Time frame: Baseline, 9 months
Salivary cortisol levels were collected as a measure of psychological stress.
5 secondary outcomes
Change Over Time on the PANSS Total Score
Time frame: Baseline, 4.5, 9, and 12 months
Change Over Time on the FFMQ
Time frame: Baseline, 4.5, 9, and 12 months
Change Over Time on the SCS
Time frame: Baseline, 4.5, 9, and 12 months
Change Over Time on the PWB
Time frame: Baseline, 4.5, 9, and 12 months
Respiratory Sinus Arrhythmia
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David L Penn, PhD principal investigator
The Unviersity of North Carolina at Chapel Hill
Diana Perkins, MD principal investigator
The Unviersity of North Carolina at Chapel Hill
Piper S Meyer-Kalos, PhD principal investigator
Minnesota Center for Chemical and Mental Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-CAT and Treatment as Usual in people with Schizophreniform Disorders, run by University of North Carolina, Chapel Hill at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Over Time on the mDES - Positive (time frame: Baseline, 4.5, 9, and 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.