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

Primary Purpose

Post-Traumatic Stress Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Slow Breathing
Meditation
Meditation and slow breathing
Sitting Quietly
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorders

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • schizophrenia,
  • schizoaffective disorder,
  • bipolar disorder,
  • psychotic disorder (not including transient dissociative states or flashbacks associated with PTSD re-experiencing symptoms),
  • any DSM-IV cognitive disorder,
  • current delirium,
  • psychiatric instability or situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to the patient or others.
  • Substance dependence disorder within 3 months of the study or
  • current substance use other than alcohol (no more than 2 drinks/day by self-report)
  • Sexual assault as primary PTSD event/s.
  • Planning to move from the area in the next year.
  • Prior or current meditation practice.

Sites / Locations

  • Oregon Health and Science University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Slow Breathing Group

Meditation Group

Meditation and Slow Breathing Group

Sitting Quietly Group

Arm Description

Outcomes

Primary Outcome Measures

Attentional Network Task: conflict effect score
Awakening cortisol values
Post-traumatic stress disorder checklist-hyperarousal score

Secondary Outcome Measures

Intrusive Thought Scale
EEG event-related negativity during Attentional Network Task
Heart rate

Full Information

First Posted
October 22, 2008
Last Updated
July 9, 2015
Sponsor
Oregon Health and Science University
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Oregon Clinical and Translational Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00778960
Brief Title
Mechanistic Pathways of Mindfulness Meditation in Post-traumatic Stress Disorder.
Official Title
Mechanistic Pathways of Mindfulness Meditation in Post-traumatic Stress Disorder.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Center for Complementary and Integrative Health (NCCIH), Oregon Clinical and Translational Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Slow Breathing Group
Arm Type
Experimental
Arm Title
Meditation Group
Arm Type
Experimental
Arm Title
Meditation and Slow Breathing Group
Arm Type
Experimental
Arm Title
Sitting Quietly Group
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Slow Breathing
Intervention Description
The slowed breathing group will be trained on a breathing device, RESPeRATE, designed to reduce respiratory rate.They will practice with RESPeRATE once a week (for 6 weeks) in the laboratory with the research staff.
Intervention Type
Behavioral
Intervention Name(s)
Meditation
Intervention Description
The Mindfulness Body Scan meditation will be used for the mindfulness meditation group.Participants will be trained once a week (for six weeks) in the laboratory by the research staff.
Intervention Type
Behavioral
Intervention Name(s)
Meditation and slow breathing
Intervention Description
A structured Mindfulness breathing will be guided by the research staff during the lab trainings. The participant will sit upright and attempt to focus attention on his or her own breath as it passes the opening of the nostrils or on the rising and falling of the abdomen or chest. Whenever attention wanders from the breath, the participant will simply notice the distracting thought and then let it go as attention is returned to the breath. Training will be given once every week for 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Sitting Quietly
Intervention Description
The SQ control group's "intervention" will include sitting quietly and listening to a neutral-content book on tape to serve as a time and attention control at each laboratory session. They will also be asked to sit quietly at home daily.
Primary Outcome Measure Information:
Title
Attentional Network Task: conflict effect score
Time Frame
Change from Baseline to Endpoint visit (one week after last training visit)
Title
Awakening cortisol values
Time Frame
Change from Baseline to Endpoint visit (one week after last training visit)
Title
Post-traumatic stress disorder checklist-hyperarousal score
Time Frame
Change from Baseline to Endpoint visit (one week after last training visit)
Secondary Outcome Measure Information:
Title
Intrusive Thought Scale
Time Frame
Change from Baseline to Endpoint visit (one week after last training visit)
Title
EEG event-related negativity during Attentional Network Task
Time Frame
Change from Baseline to Endpoint visit (one week after last training visit)
Title
Heart rate
Time Frame
Change from Baseline to Endpoint visit (one week after last training visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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: schizophrenia, schizoaffective disorder, bipolar disorder, psychotic disorder (not including transient dissociative states or flashbacks associated with PTSD re-experiencing symptoms), any DSM-IV cognitive disorder, current delirium, psychiatric instability or situational life crises, including evidence of being actively suicidal or homicidal, or any behavior which poses an immediate danger to the patient or others. Substance dependence disorder within 3 months of the study or current substance use other than alcohol (no more than 2 drinks/day by self-report) Sexual assault as primary PTSD event/s. Planning to move from the area in the next year. Prior or current meditation practice.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helane Wahbeh, ND
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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

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