Mindfulness Meditation Format Pilot Study

Depression Clinical Trial

Official title:

Mindfulness Meditation Format Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581983
• Other study ID #: IRB00008355
• Status: Completed
• Phase: Phase 1
• First received: April 7, 2012
• Last updated: July 9, 2015
• Start date: April 2012
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Internet Mindfulness Meditation
one hour session each week for six weeks
• Individual Mindfulness Meditation
one hour session each week for six weeks

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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	No