MindfulnessNCT03484390
Effects of Mindfulness on PTSD
A study testing Mindfulness-based stress reduction and Wellness Group in people with Mindfulness and Stress Disorder, Posttraumatic, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Mindfulness, Stress Disorder, Posttraumatic
- What is being tested?
- Mindfulness-based stress reduction and Wellness Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2016to 31 May 2018
- 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 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Monroe County Family Court
Rochester, New York, 14614
About this study
Official title: Effects of Mindfulness on PTSD: A Community-Based Clinical Trial Among Trauma Survivors
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.
Read the 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.
- Conditions
- Mindfulness, Stress Disorder, Posttraumatic
- Being tested
- Mindfulness-based stress reduction, Wellness Group
- Keywords
- mindfulness, posttraumatic stress disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reductionBehavioural
Wellness GroupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based stress reduction | Experimental | 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. Receives: Behavioral: Mindfulness-based stress reduction |
| Wellness Group | Active comparator | 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. Receives: Behavioral: Wellness Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 12 weeks
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).
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start15 Aug 2016
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Autumn Gallegos, University of Rochester
- Investigators
- Autumn Gallegos, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484390
- Sponsor's protocol ID
- 64139
- Status last verified
- Jun 2018
- First submitted
- 22 Mar 2018
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32969703
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness on PTSD: A Community-Based Clinical Trial Among Trauma Survivors
- ClinicalTrials.gov ID
- NCT03484390
- Acronym / sponsor ID
- 64139
- Conditions
- Mindfulness, Stress Disorder, Posttraumatic
- Keywords
- mindfulness, posttraumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 30 Mar 2018 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based stress reduction | Experimental | Behavioral: Mindfulness-based stress reductionThe 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. |
| Wellness Group | Active comparator | Behavioral: Wellness GroupThe 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- English-speaking
- Women
- 18-64 years of age
- Victim of IPV
- Meet diagnostic criteria for PTSD
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| Mindfulness-based stress reduction | Behavioural | Mindfulness-based stress reduction |
| Wellness Group | Behavioural | Wellness Group |
Primary outcome
PTSD Symptoms Checklist (PCL-5)
Time frame: 12 weeks
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.
4 secondary outcomes
Difficulties in Emotion Regulation Scale (DERS)
Time frame: 12 weeks
Heart rate variability
Time frame: 12 weeks
Useful Field of View Test (UFOV)
Time frame: 12 weeks
Five-Facet Mindfulness Questionnaire (FFMQ)
Time frame: 12 weeks
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 2 Jul 2018.
- Derived from this study: PubMed 32969703Gallegos 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.
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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.
Autumn Gallegos, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction and Wellness Group in people with Mindfulness and Stress Disorder, Posttraumatic, run by University of Rochester 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 6 inclusion and 6 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 2 Jul 2018. 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?
PTSD Symptoms Checklist (PCL-5) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03484390, which also lists 1 linked publication.
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 2 Jul 2018.