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Completed

NCT Number: NCT01581983

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

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Key information

Conditions

Posttraumatic Stress Disorder Behavior Behavioral Symptoms Depression Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet Mindfulness Meditation

Behavioral

one hour session each week for six weeks

Individual Mindfulness Meditation

Behavioral

one hour session each week for six weeks

Primary outcomes

  1. Posttraumatic Stress Disorder Checklist

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 20, 2012
Registry last updated
Jul 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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