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CompletedNCT01581983Updated Jul 13, 2015

Mindfulness Meditation Format Pilot Study

A Phase 1 interventional study of Internet Mindfulness Meditation and Individual Mindfulness Meditation in Posttraumatic Stress Disorder and Depression, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-07-13.

Sponsored by Oregon Health and Science University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Posttraumatic Stress Disorder
  • Depression
03

In context

Stress Disorders, Post-Traumatic

2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.

This study's enrollment of 8 is below the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Internet Mindfulness Meditation

    Behavioral: Internet Mindfulness Meditation

  • Experimental
    Individual Mindfulness Meditation

    Behavioral: Individual Mindfulness Meditation

Interventions

  • BehavioralInternet Mindfulness Meditation

    one hour session each week for six weeks

  • BehavioralIndividual Mindfulness Meditation

    one hour session each week for six weeks

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline to week 7.

  2. 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.

    Time frame: Change from Baseline to Week 7

07

Study locations

1 site
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01581983
Lead sponsor
Oregon Health and Science University
Responsible party
Helane Wahbeh (Assistant Professor, Oregon Health and Science University) — Principal investigator
First posted
Apr 20, 2012
Start date
Apr 2012
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Jul 13, 2015
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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