Back to resultsEffects of Mindfulness on PTSD
Primary Purpose
Mindfulness, Stress Disorder, Posttraumatic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-based stress reduction
Wellness Group
Sponsored by
About this trial
This is an interventional treatment trial for Mindfulness focused on measuring mindfulness, posttraumatic stress disorder
Eligibility Criteria
Inclusion Criteria:
- English-speaking
- Women
- 18-64 years of age
- Victim of IPV
- Meet diagnostic criteria for PTSD
- No or stable use of medications (including, for example, beta blockers).
Exclusion Criteria:
- There is suspicion or evidence of dementia or cognitive impairment (Mini-Mental State Examination score < 24) or inability to provide informed consent
- They have ever been a perpetrator of IPV
- History of schizophrenia or bipolar I disorder; current suicidality with either plan, intent, or a suicide attempt in the past 6 months
- Active substance dependence or in remission < 3 months
- Cardiovascular conditions (e.g., congestive heart failure, pacemaker, prior myocardial infarction)
- The age range was chosen to reduce heterogeneity in this pilot study, as aging is associated with changes in emotion regulation, attention, and PNS tone.
Sites / Locations
- Monroe County Family Court
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness-based stress reduction
Wellness Group
Arm Description
The MBSR program is a manualized course that includes meditation, relaxing movement, and breathing. A certified MBSR instructor will teach the courses in a group-based format for 120 minute sessions, once per week for eight weeks.
The Wellness control group uses a health education manual that provides information on various aspects of health, including diet, physical activity, sleep, stress management, and communication. The manual is used during weekly check-in phone calls for an 8-week period.
Outcomes
Primary Outcome Measures
PTSD Symptoms Checklist (PCL-5)
The PTSD Symptoms Checklist (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 asks respondents to rate how much they have been bothered by particular PTSD symptoms in the past month on a 0-4 scale.
Secondary Outcome Measures
Difficulties in Emotion Regulation Scale (DERS)
The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report measure that assesses emotion dysregulation in six domains: nonacceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity.
Heart rate variability
To assess cardiovascular measures, ECG, basal thoracic impedance (Z0), the first derivative of the impedance signal (dZ/dt), and continuous strain gauge signal, will be obtained (BioNex Mainframe, Mindware Technologies, Gahanna, OH). Three disposable ECG electrodes will be placed in a lead II configuration to record the ECG signal. Four additional disposable patient ECG spot electrodes (2 current and 2 recording electrodes) will be used to obtain the Z0 and dZ/dt signals. A strain gauge will be secured around the lower chest to record respiration rate. The BioNex will be connected to a laptop: signals will be conditioned and collected (1000 Hz sampling; 5 Hz for strain gauge) through an integrated A/D board, and written to disk and later scored (with Mindware software).
Useful Field of View Test (UFOV)
The Useful Field of View Test (UFOV) is a computerized test with 3 assessments: speed of processing; selective attention; divided attention. The test determines the minimum display duration at which participants can process information for increasingly difficult subtests and is the primary outcome for prior studies of speed of processing training.
Five-Facet Mindfulness Questionnaire (FFMQ)
The Five-Facet Mindfulness Questionnaire assesses five factors that represent mindfulness as it is currently conceptualized: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03484390
Brief Title
Effects of Mindfulness on PTSD
Official Title
Effects of Mindfulness on PTSD: A Community-Based Clinical Trial Among Trauma Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 15, 2016 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this randomized control trial is to examine the effects of a Mindfulness-Based Stress Reduction (MBSR) program on women with posttraumatic stress disorder related to intimate partner violence.
Detailed Description
Posttraumatic stress disorder is a prevalent, chronic, and debilitating disorder characterized by a reduced capacity to adapt to stressors, marked by poor regulation in the following domains: emotion, attentional function, and physiological stress. Mindfulness-based stress reduction (MBSR) holds promise for treating symptoms of trauma and PTSD as evidence suggests it targets these domains. The central hypothesis is that MBSR, which teaches non-judgmental awareness, can improve emotion regulation and attentional function, and diminish physiological stress dysregulation, which in turn will improve PTSD symptoms. We will examine changes in stress capacity and PTSD symptom severity among women survivors of intimate partner violence with PTSD after participation in an MBSR program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mindfulness, Stress Disorder, Posttraumatic
Keywords
mindfulness, posttraumatic stress disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-based stress reduction
Arm Type
Experimental
Arm Description
The MBSR program is a manualized course that includes meditation, relaxing movement, and breathing. A certified MBSR instructor will teach the courses in a group-based format for 120 minute sessions, once per week for eight weeks.
Arm Title
Wellness Group
Arm Type
Active Comparator
Arm Description
The Wellness control group uses a health education manual that provides information on various aspects of health, including diet, physical activity, sleep, stress management, and communication. The manual is used during weekly check-in phone calls for an 8-week period.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based stress reduction
Intervention Type
Behavioral
Intervention Name(s)
Wellness Group
Primary Outcome Measure Information:
Title
PTSD Symptoms Checklist (PCL-5)
Description
The PTSD Symptoms Checklist (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 asks respondents to rate how much they have been bothered by particular PTSD symptoms in the past month on a 0-4 scale.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Difficulties in Emotion Regulation Scale (DERS)
Description
The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report measure that assesses emotion dysregulation in six domains: nonacceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity.
Time Frame
12 weeks
Title
Heart rate variability
Description
To assess cardiovascular measures, ECG, basal thoracic impedance (Z0), the first derivative of the impedance signal (dZ/dt), and continuous strain gauge signal, will be obtained (BioNex Mainframe, Mindware Technologies, Gahanna, OH). Three disposable ECG electrodes will be placed in a lead II configuration to record the ECG signal. Four additional disposable patient ECG spot electrodes (2 current and 2 recording electrodes) will be used to obtain the Z0 and dZ/dt signals. A strain gauge will be secured around the lower chest to record respiration rate. The BioNex will be connected to a laptop: signals will be conditioned and collected (1000 Hz sampling; 5 Hz for strain gauge) through an integrated A/D board, and written to disk and later scored (with Mindware software).
Time Frame
12 weeks
Title
Useful Field of View Test (UFOV)
Description
The Useful Field of View Test (UFOV) is a computerized test with 3 assessments: speed of processing; selective attention; divided attention. The test determines the minimum display duration at which participants can process information for increasingly difficult subtests and is the primary outcome for prior studies of speed of processing training.
Time Frame
12 weeks
Title
Five-Facet Mindfulness Questionnaire (FFMQ)
Description
The Five-Facet Mindfulness Questionnaire assesses five factors that represent mindfulness as it is currently conceptualized: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
English-speaking
Women
18-64 years of age
Victim of IPV
Meet diagnostic criteria for PTSD
No or stable use of medications (including, for example, beta blockers).
Exclusion Criteria:
There is suspicion or evidence of dementia or cognitive impairment (Mini-Mental State Examination score < 24) or inability to provide informed consent
They have ever been a perpetrator of IPV
History of schizophrenia or bipolar I disorder; current suicidality with either plan, intent, or a suicide attempt in the past 6 months
Active substance dependence or in remission < 3 months
Cardiovascular conditions (e.g., congestive heart failure, pacemaker, prior myocardial infarction)
The age range was chosen to reduce heterogeneity in this pilot study, as aging is associated with changes in emotion regulation, attention, and PNS tone.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Autumn Gallegos, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monroe County Family Court
City
Rochester
State/Province
New York
ZIP/Postal Code
14614
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32969703
Citation
Gallegos AM, Heffner KL, Cerulli C, Luck P, McGuinness S, Pigeon WR. Effects of mindfulness training on posttraumatic stress symptoms from a community-based pilot clinical trial among survivors of intimate partner violence. Psychol Trauma. 2020 Nov;12(8):859-868. doi: 10.1037/tra0000975. Epub 2020 Sep 24.
Results Reference
derived
Learn more about this trial
Effects of Mindfulness on PTSD
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