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Clinical Trials/NCT00778960
NCT00778960
Completed
Not Applicable

Mechanistic Pathways of Mindfulness Meditation in Post-traumatic Stress Disorder.

Oregon Health and Science University1 site in 1 country102 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-Traumatic Stress Disorders
Sponsor
Oregon Health and Science University
Enrollment
102
Locations
1
Primary Endpoint
Attentional Network Task: conflict effect score
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to find out how meditation influences certain systems in the body: nervous system, hormonal system, and respiratory system. Another purpose is to see how meditation may help improve post-traumatic stress disorder symptoms.

Detailed Description

This study requires nine visits to the clinic: one screening visit, one baseline visit, six training sessions, and one endpoint visit. There will be approximately 100 people enrolled in this study who will be randomly allocated to one of four groups: a slow breathing group, a meditation group, a meditation plus slow breathing group and a sitting quietly group. Participants will undergo a telephone screening, a screening visit, baseline visit, six intervention visits (once per week for six weeks), and one endpoint visit (one week after the final training visit). A telephone screening and screening visit will ensure participant eligibility. The screening visit included structured clinician interviews on PTSD symptoms and other mental health disorders, completion of questionnaires, and receipt of home saliva collection kit. At the baseline visit, electrodes will be attached to measure the electrical activity of head, chest, skin, and respiration and blood pressure during a computer task. Intervention visits include slow breathing, meditation, mediation and slow breathing, or sitting quietly depending on which group the participant is allocated to. Breathing rates and other electrical activity of the body will be measured also. Breathing rate will be measured with an elastic band that is placed around the chest. Electrical activity will be measured by the electrodes that will be placed on the scalp, chest and skin. The endpoint visit will be exactly the same as the baseline visit.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
May 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Helane Wahbeh

Assistant Professor

Oregon Health and Science University

Eligibility Criteria

Inclusion Criteria

  • Combat veteran (defined by a score of ≥7 on the Combat exposure scale)
  • Chronic PTSD diagnosis
  • Age range (25-65 years)
  • Both genders
  • Good general medical health
  • Stable dose of medications for concurrent stable medical conditions for at least 4 weeks prior to start of the study.
  • Willing and able to provide informed consent.

Exclusion Criteria

  • Significant chronic medical illness including:
  • current cancer treatment,
  • unstable angina,
  • recent myocardial infarction,
  • current or past history of stroke,
  • transient ischemic attack,
  • congestive heart failure,
  • chronic renal or hepatic failure,
  • hypothyroidism
  • Psychiatric or behavioral illness including:

Outcomes

Primary Outcomes

Attentional Network Task: conflict effect score

Time Frame: Change from Baseline to Endpoint visit (one week after last training visit)

Awakening cortisol values

Time Frame: Change from Baseline to Endpoint visit (one week after last training visit)

Post-traumatic stress disorder checklist-hyperarousal score

Time Frame: Change from Baseline to Endpoint visit (one week after last training visit)

Secondary Outcomes

  • Intrusive Thought Scale(Change from Baseline to Endpoint visit (one week after last training visit))
  • Heart rate(Change from Baseline to Endpoint visit (one week after last training visit))
  • EEG event-related negativity during Attentional Network Task(Change from Baseline to Endpoint visit (one week after last training visit))

Study Sites (1)

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