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

Sponsors and Collaborators:	Oregon Health and Science University National Center for Complementary and Alternative Medicine (NCCAM) Oregon Clinical and Translational Research Institute
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00778960

Purpose

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.

Condition	Intervention
Post-Traumatic Stress Disorders	Behavioral: Slow Breathing Behavioral: Meditation Behavioral: Meditation and slow breathing Behavioral: Sitting Quietly

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Mechanistic Pathways of Mindfulness Meditation in Post-traumatic Stress Disorder.

Resource links provided by NLM:

MedlinePlus related topics: Post-Traumatic Stress Disorder

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

Post-traumatic Stress Disorder Checklist: hyper-arousal symptom subscale [ Time Frame: Baseline visit, End-point visit ] [ Designated as safety issue: No ]
Attentional Network Task: conflict effect score [ Time Frame: Baseline visit, End-point visit ] [ Designated as safety issue: No ]
Awakening cortisol values [ Time Frame: Baseline visit, End-point visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intrusive Thought Scale [ Time Frame: Baseline visit, End-point visit ] [ Designated as safety issue: No ]
EEG event-related negativity during Attentional Network Task [ Time Frame: Baseline visit, End-point visit ] [ Designated as safety issue: No ]
Heart rate [ Time Frame: Baseline visit, End-point visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2009
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Slow Breathing Group: Experimental	Behavioral: Slow Breathing 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.
Meditation Group: Experimental	Behavioral: Meditation 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.
Meditation and Slow Breathing Group: Experimental	Behavioral: Meditation and slow breathing 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.
Sitting Quietly Group: Placebo Comparator	Behavioral: Sitting Quietly 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.

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, and one endpoint 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Combat veteran (defined by a score of ≥7 on the Combat exposure scale)
Chronic PTSD diagnosis
Age range (18-70 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778960

Contacts

Contact: Helane Wahbeh, ND

(503) 494-3528

wahbehh@ohsu.edu

Locations

United States, Oregon
Oregon Health and Science University	Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Helane Wahbeh, ND

Sponsors and Collaborators

Oregon Health and Science University

National Center for Complementary and Alternative Medicine (NCCAM)

Oregon Clinical and Translational Research Institute

Investigators

Principal Investigator:

Helane Wahbeh, ND

Oregon Health and Science University

More Information

No publications provided

Responsible Party:	Oregon Health and Science University ( Helane Wahbeh, ND )
Study ID Numbers:	K01 AT004951-01, 4692
Study First Received:	October 22, 2008
Last Updated:	August 13, 2009
ClinicalTrials.gov Identifier:	NCT00778960 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Federal Government

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders

Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on September 01, 2009