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Evaluation of Telehealth Interventions for Post-Trauma Stress

Primary Purpose

Post Traumatic Stress Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Telehealth Intervention
Psychoeducation Telehealth Intervention
Sponsored by
VA Boston Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorders focused on measuring Mindfulness, Psychoeducation, Telehealth Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Boston Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness Telehealth for PTSD

Psychoeducation Telehealth for PTSD

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale (CAPS)
Gold standard instrument to assess symptoms of PTSD. Administered by a clinician.

Secondary Outcome Measures

PTSD Checklist
Self-report instrument to assess symptoms of PTSD.

Full Information

First Posted
July 10, 2006
Last Updated
July 28, 2011
Sponsor
VA Boston Healthcare System
Collaborators
Samueli Institute for Information Biology
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1. Study Identification

Unique Protocol Identification Number
NCT00350584
Brief Title
Evaluation of Telehealth Interventions for Post-Trauma Stress
Official Title
Evaluation of Two Telehealth Interventions Targeting Post-Trauma Stress in Combat Veterans: Comparing Mindfulness and Psychoeducation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
VA Boston Healthcare System
Collaborators
Samueli Institute for Information Biology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: The first short-term objective is to determine whether two eight-week telehealth interventions are: feasible to conduct in a population of veterans with symptoms of combat-related PTSD; effective at promoting healing specific to combat survivors as evidenced by reductions in symptoms of PTSD; 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 effective at promoting healing beyond a symptom level in combat veterans as evidenced by increases in quality of life after the interventions. 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. 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. 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: 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. 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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorders
Keywords
Mindfulness, Psychoeducation, Telehealth Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Telehealth for PTSD
Arm Type
Experimental
Arm Description
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.
Arm Title
Psychoeducation Telehealth for PTSD
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Telehealth Intervention
Intervention Description
Two in-person sessions and six telephone sessions with a therapist. Focus is on learning mindfulness skills.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation Telehealth Intervention
Intervention Description
Two in-person sessions and six telephone sessions with a therapist. Focus is on education about PTSD.
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS)
Description
Gold standard instrument to assess symptoms of PTSD. Administered by a clinician.
Time Frame
pre and post intervention
Secondary Outcome Measure Information:
Title
PTSD Checklist
Description
Self-report instrument to assess symptoms of PTSD.
Time Frame
pre and post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara L Niles, Ph.D.
Organizational Affiliation
VA Boston Healthcare System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amy K Silberbogen, Ph.D.
Organizational Affiliation
VA Boston Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States

12. IPD Sharing Statement

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Evaluation of Telehealth Interventions for Post-Trauma Stress

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