Mindfulness Meditation Format Pilot Study

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01581983
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Duration (Months): 38
• Patients Per Site Per Month: 0.2

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder; Depression	Behavioral: Internet Mindfulness Meditation; Behavioral: Individual Mindfulness Meditation	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Mindfulness Meditation Format Pilot Study
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health & Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

• Oregon Health and Science University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Helane Wahbeh, Assistant Professor, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT01581983
• Other Study ID Numbers: IRB00008355
• First Posted: Apr 20, 2012
• Last Update Posted: Jul 13, 2015
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Jul 13, 2015