Mindfulness Meditation Format Pilot Study

Phase 1

Completed

• Conditions: Depression; Posttraumatic Stress Disorder
• Interventions: Behavioral: Individual Mindfulness Meditation; Behavioral: Internet Mindfulness Meditation

• Registration Number: NCT01581983
• Lead Sponsor: Oregon Health and Science University

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 Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-07
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-20
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-09
• Last Update Posted: 2015-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual Mindfulness Meditation	Individual Mindfulness Meditation	-
Internet Mindfulness Meditation	Internet Mindfulness Meditation	-

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory	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.
Posttraumatic Stress Disorder Checklist	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.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States