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Sponsors and Collaborators: |
VA Boston Healthcare System Samueli Institute for Information Biology |
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Information provided by: | VA Boston Healthcare System |
ClinicalTrials.gov Identifier: | NCT00350584 |
Posttraumatic Stress Disorder (PTSD) is very prevalent within the veteran population and is associated with decreased quality of life and an increased risk of developing other psychiatric and physical illnesses. The overarching objective of the proposed study is to evaluate the effectiveness of two telehealth treatment conditions in promoting healing within a population of veterans with full or partial PTSD. In particular, we are targeting newly returned veterans from the Iraq and Afghanistan conflicts. Specifically, we are comparing the relative efficacy of an alternative therapeutic approach, a Mindfulness based treatment, with a Psychoeducation treatment in reducing symptoms of PTSD and more generalized psychiatric symptoms, while increasing quality of life. Of note, both treatment conditions will consist of two in-person sessions and six brief weekly telephone calls. Participants will be 58 veterans (29 per condition) recruited from the VA Boston Healthcare System. Assessment will occur before and after the delivery of the intervention. We hypothesize that while both treatments will result in improved outcomes, the Mindfulness intervention will promote more healing than the Psychoeducation intervention. Results from this project will help further our understanding of the role of mindfulness in treating PTSD, particularly in those veterans who are returning from deployment.
Condition | Intervention |
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Post Traumatic Stress Disorders |
Behavioral: Mindfulness Telehealth Intervention Behavioral: Psychoeducation Telehealth Intervention |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of Two Telehealth Interventions Targeting Post-Trauma Stress in Combat Veterans: Comparing Mindfulness and Psychoeducation |
Estimated Enrollment: | 58 |
Study Start Date: | February 2007 |
Aim: To evaluate the relative feasibility and healing efficacy of two eight-week telehealth interventions for individuals with combat-related PTSD: (1) Mindfulness and (2) Psychoeducation.
Objectives:
The first short-term objective is to determine whether two eight-week telehealth interventions are:
Hypotheses:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Barbara L Niles, Ph.D. | 857-364-4128 | Barbara.Niles@VA.gov |
Contact: Donna Ryngala, Ph.D. | 857-364-4917 | Donna.Ryngala@VA.gov |
United States, Massachusetts | |
VA Boston Healthcare System | Recruiting |
Boston, Massachusetts, United States, 02130 | |
Contact: Barbara L Niles, Ph.D. 857-364-4128 Barbara.Niles@VA.gov | |
Contact: Julie Klunk Gillis, Ph.D. 857-364-4083 Julie.KlunkGillis@VA.gov | |
Principal Investigator: Barbara L Niles, Ph.D. |
Principal Investigator: | Barbara L Niles, Ph.D. | VA Boston Healthcare System |
Principal Investigator: | Amy K Silberbogen, Ph.D. | VA Boston Healthcare System |
Study Director: | Julie Klunk Gillis, Ph.D. | VA Boston Healthcare System |
Study Director: | Donna Ryngala, Ph.D. | VA Boston Healthcare System |
Study ID Numbers: | Telehealth for PTSD Symptoms, SIIB 1 EA-0000043 |
Study First Received: | July 10, 2006 |
Last Updated: | March 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00350584 |
Health Authority: | United States: Federal Government |
Mindfulness Psychoeducation Telehealth Intervention |
Anxiety Disorders Mental Disorders Wounds and Injuries |
Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |
Pathologic Processes |