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

Tracking Information
First Received Date ^ICMJE	April 7, 2012
Last Updated Date	April 18, 2012
Start Date ^ICMJE	April 2012
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 18, 2012)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01581983 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Mindfulness Meditation Format Pilot Study
Official Title ^ICMJE	Not Provided
Brief Summary	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
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Posttraumatic Stress Disorder Depression
Intervention ^ICMJE	Behavioral: Internet Mindfulness Meditation one hour session each week for six weeks Behavioral: Individual Mindfulness Meditation one hour session each week for six weeks
Study Arm (s)	Experimental: Internet Mindfulness Meditation Intervention: Behavioral: Internet Mindfulness Meditation Experimental: Individual Mindfulness Meditation Intervention: Behavioral: Individual Mindfulness Meditation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	20
Estimated Completion Date	April 2013
Estimated Primary Completion Date	April 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	25 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01581983
Other Study ID Numbers ^ICMJE	IRB00008355
Has Data Monitoring Committee	Not Provided
Responsible Party	Helane Wahbeh, Oregon Health and Science University
Study Sponsor ^ICMJE	Oregon Health and Science University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Oregon Health and Science University
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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