SchizophreniaI-CATNCT02400502
Integrated Coping and Awareness Training
A study testing I-CAT Therapy in people with Schizophrenia, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- I-CAT Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: 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).
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
- Schizophrenia
- Being tested
- I-CAT Therapy
- Keywords
- Schizophrenia, Treatment, Meditation, Mindfulness, Stress reactivity, First Episode Psychosis, Coping
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-CAT TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| I-CAT Therapy | Experimental | 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. Receives: Behavioral: I-CAT Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Salivary Cortisol at Six Months
Salivary cortisol measured before, during and after a social stressor test.
Measured: Baseline, 6 Months
Secondary outcomes (9)
Change from Baseline Urinary Oxidative Stress Level [Isoprostane] at Six Months
Measured: 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).
Measured: 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.
Measured: Baseline, 6 Months
Change from Baseline Heart Rate Variability (HRV) Measurement at Six Months
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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.
Measured: Baseline, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- Diana O Perkins, MD, MPH, Principal investigator, University of North Carolina, Chapel HillDavid L Penn, PhD, Principal investigator, University of North Carolina, Chapel HillPiper Meyer-Kalos, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400502
- Sponsor's protocol ID
- 14-1815
- Other IDs
- R21MH100250
- Acronym
- I-CAT
- Status last verified
- Apr 2016
- First submitted
- 17 Mar 2015
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Stress Reactivity in Schizophrenia: Integrating Coping Awareness Therapy (I-CAT) Pilot Trial
- ClinicalTrials.gov ID
- NCT02400502
- Acronym / sponsor ID
- I-CAT / 14-1815
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Treatment, Meditation, Mindfulness, Stress reactivity, First Episode Psychosis, Coping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I-CAT Therapy | Experimental | Behavioral: I-CAT TherapyIntegrated 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
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-CAT TherapyI-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. | Behavioural | I-CAT Therapy |
Primary outcome
Change from Baseline Salivary Cortisol at Six Months
Time frame: Baseline, 6 Months
Salivary cortisol measured before, during and after a social stressor test.
9 secondary outcomes
Change from Baseline Urinary Oxidative Stress Level [Isoprostane] at Six Months
Time frame: Baseline, 6 Months
Change from Baseline Positive and Negative Syndrome Scale (PANSS) Total Score at Six Months
Time frame: Baseline, 6 Months
Change from Baseline Quality of Life Scale (QLS; Bilker et al., 2003) Total Score at Six Months
Time frame: Baseline, 6 Months
Change from Baseline Heart Rate Variability (HRV) Measurement at Six Months
Time frame: Baseline, 6 Months
Change from Baseline Modified Differential Emotions Scale (mDES) Positive Emotion Sub Scale Score at Six Months
Time frame: Baseline, 6 Months
Change from Baseline Perceived Stress Scale (PSS) Total Score at Six Months
Time frame: Baseline, 6 Months
Change from Baseline Brief COPE Scale (Assisted Format) Total Score at Six Months
Time frame: Baseline, 6 Months
Change from Baseline Five Facet Mindfulness Questionnaire (FFMQ) Total Score at Six Months
Time frame: Baseline, 6 Months
Change from Baseline Psychological Well-Being (PWB) Scale Total Score at Six Months
Time frame: Baseline, 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
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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.
Diana O Perkins, MD, MPH principal investigator
University of North Carolina, Chapel Hill
David L Penn, PhD principal investigator
University of North Carolina, Chapel Hill
Piper Meyer-Kalos, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-CAT Therapy in people with Schizophrenia, run by University of North Carolina, Chapel Hill at 1 site 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 2 inclusion and 7 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 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from Baseline Salivary Cortisol at Six Months (time frame: Baseline, 6 Months). 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 8 Apr 2016.