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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Oregon Clinical and Translational Research Institute
Information provided by (Responsible Party):
Helane Wahbeh, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00778960
First received: October 22, 2008
Last updated: September 11, 2013
Last verified: September 2013
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Mechanistic Pathways of Mindfulness Meditation in Post-traumatic Stress Disorder.

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Attentional Network Task: conflict effect score [ Time Frame: Change from Baseline to Endpoint visit (one week after last training visit) ] [ Designated as safety issue: No ]
  • Awakening cortisol values [ Time Frame: Change from Baseline to Endpoint visit (one week after last training visit) ] [ Designated as safety issue: No ]
  • Post-traumatic stress disorder checklist-hyperarousal score [ Time Frame: Change from Baseline to Endpoint visit (one week after last training visit) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intrusive Thought Scale [ Time Frame: Change from Baseline to Endpoint visit (one week after last training visit) ] [ Designated as safety issue: No ]
  • EEG event-related negativity during Attentional Network Task [ Time Frame: Change from Baseline to Endpoint visit (one week after last training visit) ] [ Designated as safety issue: No ]
  • Heart rate [ Time Frame: Change from Baseline to Endpoint visit (one week after last training visit) ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Slow Breathing Group 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.
Experimental: Meditation Group 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.
Experimental: Meditation and Slow Breathing Group 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.
Placebo Comparator: Sitting Quietly Group 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 (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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 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 (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Oregon Clinical and Translational Research Institute
Investigators
Principal Investigator: Helane Wahbeh, ND Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Helane Wahbeh, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00778960     History of Changes
Other Study ID Numbers: K01 AT004951-01, K01AT004951-01, 4692
Study First Received: October 22, 2008
Last Updated: September 11, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 30, 2014