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Completed

NCT Number: NCT03484390

Effects of Mindfulness on PTSD

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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Key information

Conditions

Mindfulness Mental Disorders Stress Disorder, Posttraumatic Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Monroe County Family Court

Rochester, New York, 14614, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness-Based Stress Reduction

Behavioral

Wellness Group

Behavioral

Primary outcomes

  1. 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.

Secondary outcomes

  1. Difficulties in Emotion Regulation Scale (DERS)

    Time frame: 12 weeks

    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.

  2. Heart rate variability

    Time frame: 12 weeks

    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).

  3. Useful Field of View Test (UFOV)

    Time frame: 12 weeks

    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.

  4. Five-Facet Mindfulness Questionnaire (FFMQ)

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Effects of Mindfulness on PTSD: A Community-Based Clinical Trial Among Trauma Survivors

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 30, 2018
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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