Use of Mindfulness Meditation With Iraqi/Afghanistan War Veterans

NCT00375531 | Withdrawn

• 2 other identifiers: 00890USUHS #PA181BO-4
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: The primary objective of this study is to conduct a randomized pilot study on the efficacy of Mindfulness Meditation (MfM) on sleep in post war Iraqi/Afghanistan veterans with PTSD. It is hypothesized that the change in sleep (measured by actigraphy), sleep self report measures, and PTSD symptoms (measured by the PTSD Checklist) from baseline, 8 weeks and 12 weeks will be greater for veterans with PTSD who are treated with MfM, controlling for pretreatment values and other clinical and demographic factors. A secondary objective will investigate whether there is an improvement in psychological wellness (measured by optimism, perceived wellness, and spirituality) following MfM treatments. It is hypothesized that change in optimism, perceived wellness, and spirituality from baseline, 8 weeks and 12 weeks will improve in veterans with PTSD who are treated with MfM, controlling for pretreatment values and other clinical and demographic factors. Physiological measures of actigraphy in the home will be done at baseline, eight weeks, and twelve weeks. Subjective measure of sleep include measurements of sleep and quality of life(FOSQ) and subjective sleep quality (PSQI). Other self-report measures that will examine psychological wellness include the Life Orientation Test (LOT), the Perceived Wellness Survey (PWS) and the Spirituality Assessment Scale (SAS).

Conditions

PTSD; Stress

Keywords

Post Traumatic Stress Disorder; Mindfulness Meditation

Outcome Measures

Primary Outcomes (3)

• Sleep & PTSD SYMPTOM SEVERITY -- (measured by) Actigraphy, PTSD Checklist (PCL), Functional Outcomes of Sleep Questionnaire (FOSQ),Pittsburgh Sleep Quality Index (PSQI) -- Self-report measures and actigraphy readings will be

• collected at baseline, 8 weeks, and 12 weeks in

• both groups.

Secondary Outcomes (1)

• PSYCHOLOGICAL WELLNESS ASSESSMENTS -- (measured by) Life Orientation Test (LOT), Perceived Wellness Survey (PWS), Spirituality Assessment Scale (SAS)

Interventions

Mindfulness Meditation (MfM) BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Iraqi War veterans who have returned from deployment for at least 3 months
• The veterans must be willing to practice MfM for 45 minutes each day and agree to follow all treatment protocols.

You may not qualify if:

• Patients with a documented diagnosis of:
• a thought disorder
• a bipolar disorder
• a borderline personality disorder
• active substance abuse/dependence,
• Patients that are:
• homeless
• have pending legal dispositions
• are unable to hear, read, visualize, and/or comprehend the assessment

Sponsors & Collaborators

• Corporal Michael J. Crescenz VA Medical Center: lead
• Samueli Institute for Information Biology: collaborator
• University of Pennsylvania: collaborator

Study Sites (1)

Philadelphia VAMC

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nina M Chychula, Ph.D.

  Philadelphia VAMC and University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: September 12, 2006
• First Posted: September 13, 2006
• Study Start: October 1, 2006
• Study Completion: August 1, 2007
• Last Updated: January 29, 2018

Record last verified: 2007-10

Locations

US (1)