Mindfulness Meditation Format Pilot Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Helane Wahbeh, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01581983
First received: April 7, 2012
Last updated: September 11, 2013
Last verified: September 2013

April 7, 2012
September 11, 2013
April 2012
April 2014   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01581983 on ClinicalTrials.gov Archive Site
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Mindfulness Meditation Format Pilot Study
Not Provided

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Posttraumatic Stress Disorder
  • Depression
  • Behavioral: Internet Mindfulness Meditation
    one hour session each week for six weeks
  • Behavioral: Individual Mindfulness Meditation
    one hour session each week for six weeks
  • Experimental: Internet Mindfulness Meditation
    Intervention: Behavioral: Internet Mindfulness Meditation
  • Experimental: Individual Mindfulness Meditation
    Intervention: Behavioral: Individual Mindfulness Meditation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
25 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01581983
IRB00008355
Not Provided
Helane Wahbeh, Oregon Health and Science University
Oregon Health and Science University
Not Provided
Not Provided
Oregon Health and Science University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP