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Evaluation of Telehealth Interventions for Post-Trauma Stress
This study is currently recruiting participants.
Verified by VA Boston Healthcare System, March 2007
Sponsors and Collaborators: VA Boston Healthcare System
Samueli Institute for Information Biology
Information provided by: VA Boston Healthcare System
ClinicalTrials.gov Identifier: NCT00350584
  Purpose

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
Post Traumatic Stress Disorders
Behavioral: Mindfulness Telehealth Intervention
Behavioral: Psychoeducation Telehealth Intervention

MedlinePlus related topics: Anxiety Injuries Post-Traumatic Stress Disorder Wounds
U.S. FDA Resources
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

Further study details as provided by VA Boston Healthcare System:

Primary Outcome Measures:
  • Clinician-Administered PTSD Scale (CAPS)
  • Pennebaker Inventory of Limbic Languidness (PILL)
  • The Short Form – 36 – Veteran Version (SF-36V)
  • Beck Depression Inventory (BDI)
  • Participant Satisfaction Questionnaire
  • Beck Anxiety Inventory (BAI)
  • Alcohol and Drug Use Section of the Addiction Severity Index (ASI)
  • Mindful Attention Awareness Scale (MAAS)
  • Understanding of PTSD Questionnaire (UPQ)

Estimated Enrollment: 58
Study Start Date: February 2007
Detailed Description:

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:

  1. The first short-term objective is to determine whether two eight-week telehealth interventions are:

    1. feasible to conduct in a population of veterans with symptoms of combat-related PTSD;
    2. effective at promoting healing specific to combat survivors as evidenced by reductions in symptoms of PTSD;
    3. effective at promoting more generalized healing in combat veterans as evidenced by reductions in symptoms that are often co-morbid with PTSD (e.g., depression, anxiety, and substance abuse problem severity); and
    4. effective at promoting healing beyond a symptom level in combat veterans as evidenced by increases in quality of life after the interventions.
  2. The second short-term objective of this study is to determine whether a Mindfulness intervention will be more effective at promoting healing than a Psychoeducation intervention. This comparison will be made on the levels of specific PTSD symptoms, more general co-morbid symptoms, and global quality of life.
  3. The long-term objectives of this line of research are to identify mechanisms of action in a Mindfulness Telehealth Intervention that allow healing and promote increased quality of life in individuals with PTSD.
  4. An additional long-term objective of this project is to contribute to the development of efficacious wellness interventions that can promote healing after combat exposure in veterans returning from current military conflicts (e.g. Iraq and Afghanistan).

Hypotheses:

  1. It is hypothesized that both eight-week telehealth interventions (Mindfulness and Psychoeducation) will be feasible in a population of veterans with symptoms of combat-related PTSD. Specifically, satisfaction and compliance with the interventions is predicted to be high.
  2. It is hypothesized that both eight-week telehealth interventions (Mindfulness and Psychoeducation) will be effective at promoting healing and reducing symptoms of PTSD. Specifically, it is predicted that levels of PTSD measured post-intervention will be lower than levels measured pre-intervention.
  3. It is hypothesized that both eight-week telehealth interventions (Mindfulness and Psychoeducation) will be effective at promoting healing and reducing symptoms co-morbid with PTSD. Specifically, it is predicted that levels of depression, anxiety, and substance abuse problem severity measured post-intervention will be lower than levels measured pre-intervention.
  4. It is hypothesized that both eight-week telehealth interventions (Mindfulness and Psychoeducation) will be effective at improving quality of life. Specifically, it is predicted that levels of quality of life measured post-intervention will be higher than levels measured pre-intervention.
  5. Although it is hypothesized that both eight-week interventions will be effective at healing for veterans with PTSD symptoms, the holistic Mindfulness intervention is hypothesized to be more effective at promoting healing and reducing symptoms of PTSD and co-morbid disorders and improving quality of life than the Psychoeducation intervention. Specifically, it is predicted that levels of PTSD, depression, anxiety, and substance abuse problem severity will be lower post-intervention and quality of life will be higher for those individuals in the Mindfulness condition than for those in the Psychoeducation condition.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • documented United States military service in war or peacekeeping theater
  • a current diagnosis of PTSD or partial PTSD
  • access to a telephone

Exclusion Criteria:

  • veteran’s mental status precludes completion of the assessment procedures (e.g., severe organicity or active psychosis)
  • the veteran’s regimen of psychiatric medication has not been stable over the past two months (if applicable)
  • the veteran has symptoms consistent with a diagnosis of alcohol or drug dependence within the past three months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350584

Contacts
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

Locations
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.            
Sponsors and Collaborators
VA Boston Healthcare System
Samueli Institute for Information Biology
Investigators
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
  More Information

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

Keywords provided by VA Boston Healthcare System:
Mindfulness
Psychoeducation
Telehealth Intervention

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Wounds and Injuries
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009