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Mindfulness Meditation Format Pilot Study

This study is currently recruiting participants.
Verified April 2012 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
Helane Wahbeh, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01581983
First received: April 7, 2012
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to assess feasibility of an internet and individual format of mindfulness meditation in people with posttraumatic stress disorder (PTSD) and depression symptoms


Condition Intervention Phase
Posttraumatic Stress Disorder
Depression
 Behavioral: Internet Mindfulness Meditation
Behavioral: Individual Mindfulness Meditation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Posttraumatic Stress Disorder Checklist [ Time Frame: Change from baseline to week 7. ] [ Designated as safety issue: No ]
    The Posttraumatic Stress Disorder Checklist will be administered immediately before their first intervention session and within one week of their last intervention session. The primary outcome is the change in score on this instrument from baseline to week 7.

  • Beck Depression Inventory [ Time Frame: Change from Baseline to Week 7 ] [ Designated as safety issue: No ]
    The Beck Depression Inventory will be administered immediately before their first intervention session and within one week of their last intervention session. The primary outcome is the change in score on this instrument from baseline to week 7.


Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Internet Mindfulness Meditation Behavioral: Internet Mindfulness Meditation
one hour session each week for six weeks
Experimental: Individual Mindfulness Meditation Behavioral: Individual Mindfulness Meditation
one hour session each week for six weeks

Detailed Description:

Internet and individual formats of mindfulness meditation have not been previously evaluated. In order establish feasibility of such formats a pilot study is need. The current study will randomize up to 20 people with PTSD and depression symptoms and evaluate changes in PTSD and depression symptoms from before to after the internet and individual mindfulness meditation interventions.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Good general health
  • Age 25-65
  • Access to internet
  • PTSD symptoms (score >14 on PTSD screen)
  • Depression symptoms (endorsement of one question on depression screen)
  • Stable on medications six weeks prior to the study
  • Willing to be stable on medications during study

Exclusion Criteria:

  • Significant potentially life-limiting acute medical illness
  • Risk for suicide
  • >2 drinks/day of alcohol and street drug use besides marijuana
  • Current daily meditation practice
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581983

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Helane Wahbeh, ND, MCRq     503-494-3528        
Principal Investigator: Helane Wahbeh, ND, MCR            
Sponsors and Collaborators
Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Helane Wahbeh, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01581983     History of Changes
Other Study ID Numbers: IRB00008355
Study First Received: April 7, 2012
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
 Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on May 16, 2013