Effects of Mindfulness on PTSD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-15

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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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

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Mindfulness Stress Disorder, Posttraumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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Mindfulness-based stress reduction

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.

Group Type EXPERIMENTAL

Mindfulness-based stress reduction

Intervention Type BEHAVIORAL

Wellness Group

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.

Group Type ACTIVE_COMPARATOR

Wellness Group

Intervention Type BEHAVIORAL

Interventions

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Mindfulness-based stress reduction

Intervention Type BEHAVIORAL

Wellness Group

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No