Mindfulness Meditation Format Pilot Study

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

Study Overview

• Status: Completed
• Conditions: Depression; Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Internet Mindfulness Meditation; Behavioral: Individual Mindfulness Meditation

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: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet Mindfulness Meditation	Behavioral: Internet Mindfulness Meditation; one hour session each week for six weeks
Experimental: Individual Mindfulness Meditation	Behavioral: Individual Mindfulness Meditation; one hour session each week for six weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: April 7, 2012
• First Submitted That Met QC Criteria: April 18, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Estimate): July 13, 2015
• Last Update Submitted That Met QC Criteria: July 9, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: IRB00008355