Clinical trial NCT02400502: Integrated Coping and Awareness Training
Official title: Targeting Stress Reactivity in Schizophrenia: Integrating Coping Awareness Therapy (I-CAT) Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Treatment
Meditation
Mindfulness
Stress reactivity
First Episode Psychosis
Coping
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2015-03-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Salivary Cortisol at Six Months
timeFrame: Baseline, 6 Months
Secondary outcomes:
measure: Change from Baseline Urinary Oxidative Stress Level [Isoprostane] at Six Months
timeFrame: Baseline, 6 Months
measure: Change from Baseline Positive and Negative Syndrome Scale (PANSS) Total Score at Six Months
timeFrame: Baseline, 6 Months
measure: Change from Baseline Quality of Life Scale (QLS; Bilker et al., 2003) Total Score at Six Months
timeFrame: Baseline, 6 Months
measure: Change from Baseline Heart Rate Variability (HRV) Measurement at Six Months
timeFrame: Baseline, 6 Months
measure: Change from Baseline Modified Differential Emotions Scale (mDES) Positive Emotion Sub Scale Score at Six Months
timeFrame: Baseline, 6 Months
measure: Change from Baseline Perceived Stress Scale (PSS) Total Score at Six Months
timeFrame: Baseline, 6 Months
measure: Change from Baseline Brief COPE Scale (Assisted Format) Total Score at Six Months
timeFrame: Baseline, 6 Months
measure: Change from Baseline Five Facet Mindfulness Questionnaire (FFMQ) Total Score at Six Months
timeFrame: Baseline, 6 Months
measure: Change from Baseline Psychological Well-Being (PWB) Scale Total Score at Six Months
timeFrame: Baseline, 6 Months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Diana O Perkins, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: David L Penn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Piper Meyer-Kalos, PhD
role: PRINCIPAL_INVESTIGATOR
References: