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Evaluation of Telehealth Interventions for Post-Trauma Stress

This study has been completed.
Sponsor:
Collaborator:
Samueli Institute for Information Biology
Information provided by:
VA Boston Healthcare System
ClinicalTrials.gov Identifier:
NCT00350584
First received: July 10, 2006
Last updated: July 28, 2011
Last verified: January 2009
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Two Telehealth Interventions Targeting Post-Trauma Stress in Combat Veterans: Comparing Mindfulness and Psychoeducation

Resource links provided by NLM:


Further study details as provided by VA Boston Healthcare System:

Primary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: pre and post intervention ] [ Designated as safety issue: No ]
    Gold standard instrument to assess symptoms of PTSD. Administered by a clinician.


Secondary Outcome Measures:
  • PTSD Checklist [ Time Frame: pre and post intervention ] [ Designated as safety issue: No ]
    Self-report instrument to assess symptoms of PTSD.


Enrollment: 33
Study Start Date: February 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness Telehealth for PTSD
Participants receive two in-person sessions and 6 sessions over the phone. Participants are introduced to mindfulness concepts. CDs with guided meditation exercises are given to participants and they are asked to practice between sessions.
Behavioral: Mindfulness Telehealth Intervention
Two in-person sessions and six telephone sessions with a therapist. Focus is on learning mindfulness skills.
Active Comparator: Psychoeducation Telehealth for PTSD
Participants receive two in-person sessions and six telehealth sessions with education about symptoms of PTSD and coping strategies. In addition, participants are asked to read short homework assignments and think about them during the week; these are discussed in weekly sessions.
Behavioral: Psychoeducation Telehealth Intervention
Two in-person sessions and six telephone sessions with a therapist. Focus is on education about PTSD.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350584

Locations
United States, Massachusetts
VA Boston Healthcare System
Boston, Massachusetts, United States, 02130
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
  More Information

No publications provided

Responsible Party: Barbara L. Niles, Ph.D., Principal Investigator, VA Boston Healthcare System, National Center for PTSD
ClinicalTrials.gov Identifier: NCT00350584     History of Changes
Other Study ID Numbers: Telehealth for PTSD Symptoms, SIIB 1 EA-0000043
Study First Received: July 10, 2006
Last Updated: July 28, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 20, 2014