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

Post-Traumatic Stress Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778960
• Other study ID #: K01AT004951-01
• Secondary ID: K01AT004951-0146
• Status: Completed
• Phase: N/A
• First received: October 22, 2008
• Last updated: July 9, 2015
• Start date: January 2009
• Est. completion date: May 2014

Study information

• Verified date: July 2015
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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
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
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
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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Center for Complementary and Integrative Health (NCCIH), Oregon Clinical and Translational Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attentional Network Task: conflict effect score		Change from Baseline to Endpoint visit (one week after last training visit)	No
Primary	Awakening cortisol values		Change from Baseline to Endpoint visit (one week after last training visit)	No
Primary	Post-traumatic stress disorder checklist-hyperarousal score		Change from Baseline to Endpoint visit (one week after last training visit)	No
Secondary	Intrusive Thought Scale		Change from Baseline to Endpoint visit (one week after last training visit)	No
Secondary	EEG event-related negativity during Attentional Network Task		Change from Baseline to Endpoint visit (one week after last training visit)	No
Secondary	Heart rate		Change from Baseline to Endpoint visit (one week after last training visit)	No