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

NCT00778960 | Completed

• 2 other identifiers: K01AT004951-014692
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Traumatic Stress Disorders

Outcome Measures

Primary Outcomes (3)

• Attentional Network Task: conflict effect score

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

• Awakening cortisol values

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

• Post-traumatic stress disorder checklist-hyperarousal score

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

Secondary Outcomes (3)

• Intrusive Thought Scale

  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)

• Heart rate

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

Study Arms (4)

Slow Breathing Group

EXPERIMENTAL

Behavioral: Slow Breathing

Meditation Group

EXPERIMENTAL

Behavioral: Meditation

Meditation and Slow Breathing Group

EXPERIMENTAL

Behavioral: Meditation and slow breathing

Sitting Quietly Group

PLACEBO COMPARATOR

Behavioral: Sitting Quietly

Interventions

Slow Breathing BEHAVIORAL

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.

Slow Breathing Group

Meditation BEHAVIORAL

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 Group

Meditation and slow breathing BEHAVIORAL

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.

Meditation and Slow Breathing Group

Sitting Quietly BEHAVIORAL

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.

Sitting Quietly Group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Oregon Clinical and Translational Research Institute: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Meditation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Helane Wahbeh, ND

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 24, 2008
• Study Start: January 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 13, 2015

Record last verified: 2015-07

Locations

US (1)