Study Results
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View full resultsBasic Information
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COMPLETED
NA
91 participants
INTERVENTIONAL
2019-02-04
2019-12-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mindful Breathing
Participants receive training in a mindful breathing skill to regulate their emotional distress during a stressor task. They will then receive one week of reminders to use this skill, delivered through their mobile phones.
Mindful Breathing
Training in a mindful breathing skill that reduces emotional distress
Habituation
Participants receive an exposure/habituation intervention to regulate their emotional distress during a stressor task. They will then receive one week of reminders, delivered through their mobile phones.
Habituation
An exposure procedure that reduces emotional distress through habituation
Control
Participants complete the stressor task with no emotion regulation training. Similar to the other conditions, they will then receive one week of reminders, delivered through their mobile phones to test for placebo effects.
Control
No emotion regulation intervention, placebo
Interventions
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Mindful Breathing
Training in a mindful breathing skill that reduces emotional distress
Habituation
An exposure procedure that reduces emotional distress through habituation
Control
No emotion regulation intervention, placebo
Eligibility Criteria
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Inclusion Criteria
2. have a smartphone and agree to receive text-messages;
3. have difficulty with their relationships or social interactions;
4. high emotion dysregulation, assessed with the Difficulties with Emotion Regulation Scale (DERS)(Gratz \& Roemer, 2004) with scores over 90.
Exclusion Criteria
2. Meets full criteria for any current psychotic disorder;
3. Currently/chronically homeless;
4. Current suicidal ideation;
5. Psychiatric hospitalization within past 6 months;
6. Unable to read, blind or deaf. Our previous study recruited only participants who were currently in treatment, but this study will include both participants who are currently in treatment, as well as those who are not in treatment.
7. high self-reported autistic traits, as assessed by the Autism Spectrum Quotient (Auyeung \& Baron-Cohen, 2012).
18 Years
55 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Mind and Life Institute, Hadley, Massachusetts
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Mark Z Rosenthal, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Pro00089935
Identifier Type: -
Identifier Source: org_study_id
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