Integrated Coping and Awareness Training

Schizophrenia Clinical Trial

— I-CAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400502
• Other study ID #: 14-1815
• Secondary ID: R21MH100250
• Status: Completed
• Phase: N/A
• First received: March 17, 2015
• Last updated: April 7, 2016
• Start date: March 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Salivary Cortisol at Six Months	Salivary cortisol measured before, during and after a social stressor test.	Baseline, 6 Months	No
Secondary	Change from Baseline Urinary Oxidative Stress Level [Isoprostane] at Six Months		Baseline, 6 Months	No
Secondary	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	No
Secondary	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	No
Secondary	Change from Baseline Heart Rate Variability (HRV) Measurement at Six Months		Baseline, 6 Months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No