Back to resultsMindfulness Meditation Format Pilot Study
Primary Purpose
Posttraumatic Stress Disorder, Depression
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Internet Mindfulness Meditation
Individual Mindfulness Meditation
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder
Eligibility 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
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Internet Mindfulness Meditation
Individual Mindfulness Meditation
Arm Description
Outcomes
Primary Outcome Measures
Posttraumatic Stress Disorder Checklist
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01581983
First Posted
April 7, 2012
Last Updated
July 9, 2015
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT01581983
Brief Title
Mindfulness Meditation Format Pilot Study
Official Title
Mindfulness Meditation Format Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet Mindfulness Meditation
Arm Type
Experimental
Arm Title
Individual Mindfulness Meditation
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Internet Mindfulness Meditation
Intervention Description
one hour session each week for six weeks
Intervention Type
Behavioral
Intervention Name(s)
Individual Mindfulness Meditation
Intervention Description
one hour session each week for six weeks
Primary Outcome Measure Information:
Title
Posttraumatic Stress Disorder Checklist
Description
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.
Time Frame
Change from baseline to week 7.
Title
Beck Depression Inventory
Description
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.
Time Frame
Change from Baseline to Week 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Mindfulness Meditation Format Pilot Study
We'll reach out to this number within 24 hrs