NCT03484390

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

1.8 years

First QC Date

March 22, 2018

Last Update Submit

June 29, 2018

Conditions

MindfulnessStress Disorder, Posttraumatic

Keywords

mindfulnessposttraumatic stress disorder

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (4)

  • Difficulties in Emotion Regulation Scale (DERS)

    12 weeks

  • Heart rate variability

    12 weeks

  • Useful Field of View Test (UFOV)

    12 weeks

  • Five-Facet Mindfulness Questionnaire (FFMQ)

    12 weeks

Study Arms (2)

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.

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.

Behavioral: Wellness Group

Interventions

Mindfulness-based stress reductionBEHAVIORAL
Mindfulness-based stress reduction
Wellness GroupBEHAVIORAL
Wellness Group

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • English-speaking
  • Women
  • years of age
  • Victim of IPV
  • Meet diagnostic criteria for PTSD
  • No or stable use of medications (including, for example, beta blockers).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monroe County Family Court

Rochester, New York, 14614, United States

Location

Related Publications (1)

  • 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.

    PMID: 32969703DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Autumn Gallegos, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 22, 2018

First Posted

March 30, 2018

Study Start

August 15, 2016

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

July 2, 2018

Record last verified: 2018-06

Locations

US(1)