Evaluation of Telehealth Interventions for Post-Trauma Stress
NCT ID: NCT00350584
Last Updated: 2011-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2007-02-28
2008-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Mindfulness Telehealth Intervention
Two in-person sessions and six telephone sessions with a therapist. Focus is on learning mindfulness skills.
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.
Psychoeducation Telehealth Intervention
Two in-person sessions and six telephone sessions with a therapist. Focus is on education about PTSD.
Interventions
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Mindfulness Telehealth Intervention
Two in-person sessions and six telephone sessions with a therapist. Focus is on learning mindfulness skills.
Psychoeducation Telehealth Intervention
Two in-person sessions and six telephone sessions with a therapist. Focus is on education about PTSD.
Eligibility Criteria
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Inclusion Criteria
* a current diagnosis of PTSD or partial PTSD
* access to a telephone
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Samueli Institute for Information Biology
OTHER
VA Boston Healthcare System
FED
Responsible Party
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VA Boston Healthcare System, National Center for PTSD
Principal Investigators
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Barbara L Niles, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
VA Boston Healthcare System
Amy K Silberbogen, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
VA Boston Healthcare System
Locations
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VA Boston Healthcare System
Boston, Massachusetts, United States
Countries
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Other Identifiers
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SIIB 1 EA-0000043
Identifier Type: -
Identifier Source: secondary_id
Telehealth for PTSD Symptoms
Identifier Type: -
Identifier Source: org_study_id