Mindfulness Meditation Format Pilot Study
1 other identifier
interventional
8
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 7, 2012
CompletedFirst Posted
Study publicly available on registry
April 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJuly 13, 2015
July 1, 2015
3.2 years
April 7, 2012
July 9, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Change 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.
Change from Baseline to Week 7
Study Arms (2)
Internet Mindfulness Meditation
EXPERIMENTALIndividual Mindfulness Meditation
EXPERIMENTALInterventions
one hour session each week for six weeks
one hour session each week for six weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health & Science University
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 7, 2012
First Posted
April 20, 2012
Study Start
April 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
July 13, 2015
Record last verified: 2015-07