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Mindfulness Meditation Format Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01581983
First Posted: April 20, 2012
Last Update Posted: July 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Helane Wahbeh, Oregon Health and Science University
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness Meditation Format Pilot Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Posttraumatic Stress Disorder Checklist [ Time Frame: Change from baseline to week 7. ]
    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 ]
    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.


Enrollment: 8
Study Start Date: April 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581983


Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
  More Information

Responsible Party: Helane Wahbeh, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01581983     History of Changes
Other Study ID Numbers: IRB00008355
First Submitted: April 7, 2012
First Posted: April 20, 2012
Last Update Posted: July 13, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders