Post Traumatic Stress Disorder, PTSDNCT01623219
Community-Based Telemedicine to Reduce Risk to Georgia Veterans With Post Traumatic Stress Disorder
A study testing Prolonged Exposure Therapy in people with Post Traumatic Stress Disorder, PTSD, run by Emory University.
Trial summary
The investigator proposes to examine treatment for Posttraumatic Stress Disorder for Veterans who served in Iraq and Afghanistan provided through telemedicine which connects patients to doctors in different locations using the internet. In this study, Veterans will receive prolonged exposure therapy (PE). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Traumatic Stress Disorder, PTSD
- What is being tested?
- Prolonged Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must meet DSM-IV criteria for PTSD due to exposure to a trauma while serving in Operation Iraqi Freedom, Operation Enduring Freedom-Afghanistan, and/or Operation New Dawn.
- Patients must be literate in English.
- Patients must be medically healthy or medically stable such that the stress of the therapy is not contraindicated.
- Participants must comprehend his or her role in treatment and the risks involved in order to be entered.
Who cannot join
- Patients with a history of mania, schizophrenia, or other psychoses
- Patients with prominent suicidal ideation
- Patients with current alcohol or drug dependence
- Patients with special medical conditions such as pregnancy, renal insufficiency, those with various chronic diseases or a history of significant head injury
About this study
Official title: Community-Based Telemedicine to Reduce Risk to Georgia Veterans With PTSD
The investigator proposes to examine treatment for Posttraumatic Stress Disorder for Veterans who served in Iraq and Afghanistan provided through telemedicine which connects patients to doctors in different locations using the internet. In this study, Veterans will receive prolonged exposure therapy (PE). This treatment has been shown to be effective in reducing PTSD symptoms. For this study 9 weekly 90 minute sessions will be given over a period of up to 3 months. The first 2 sessions of each treatment will involve education, rational and treatment preparation. Sessions 3-9 will consist of recounting the traumatic event out loud and repeatedly. The purpose of this study is to determine if this treatment is effective when given through telehealth. To this end, the investigators propose to enroll up to 20 individuals who will access the investigators services through the GA telehealth network who has hundreds of telehealth sites across the state of Georgia. Patients will go to these sites to access the investigators therapists using GA telehealth equipment. The investigators hypothesize that PE delivered remotely through telemedicine will work to reduce the symptoms of PTSD.
- Conditions
- Post Traumatic Stress Disorder, PTSD
- Being tested
- Prolonged Exposure Therapy
- Keywords
- PTSD, trauma, combat trauma, veterans, telemedicine, prolonged exposure
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Exposure TherapyBehavioural
Also called PE, Exposure Therapy, Imaginal Exposure
Exposure therapy refers to several cognitive behavioral treatment programs that involve confronting feared but safe thoughts, images, objects, situations, or activities in order to reduce unrealistic fear and anxiety. Exposure therapy for PTSD involves prolonged, imaginal exposure to the patient's traumatic memory and in vivo (in real life) exposure to trauma reminders. Prolonged exposure (PE) is a specific exposure therapy program that consists of five components: (1) psychoeducation (2) training in controlled breathing, (3) prolonged imaginal exposure to the trauma memory conducted in therapy sessions and repeated as homework, (4) prolonged in vivo exposure implemented as homework, and (5) processing of the traumatic material to correct maladaptive cognitions.
| Study group | Role | What they receive |
|---|---|---|
| TeleMedicine Prolonged Exposure | Experimental | Veterans will receive prolonged exposure therapy (PE)delivered via telemedicine instead of in person. For this study 9 weekly 90 minute sessions will be given over a period of up to 3 months. The first 2 sessions of each treatment will involve education, rational and treatment preparation. Sessions 3-9 will consist of recounting the traumatic event out loud and repeatedly. The purpose of this study is to determine if this treatment is effective when given through telehealth. Receives: Behavioral: Prolonged Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAPS-Clinician Administered PTSD Scale
Measured: Post-Treatment (10 weeks)
Secondary outcomes (4)
BDI-II-Beck Depression Inventory-II
Measured: Post-Treatment (10 weeks)
Credibility/Expectancy Questionnaire-CEQ
Measured: post treatment (10 weeks)
Client Satisfaction Questionnaire-CSQ
Measured: post treatment (10 weeks)
PTSD Symptom Scale Self Report-PSS-SR
Measured: Post-Treatment (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2013
Why it stopped: Unable to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress Disorder, PTSDStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Barbara O. Rothbaum, PhD, Emory University
- Investigators
- Barbara O Rothbaum, PhD, ABPP, Principal investigator, Emory University, School of Medicine, Dept. of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623219
- Sponsor's protocol ID
- IRB00055554
- Other IDs
- Telemedicine_ECIC_2012
- Status last verified
- Aug 2015
- First submitted
- 12 Jun 2012
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Telemedicine to Reduce Risk to Georgia Veterans With PTSD
- ClinicalTrials.gov ID
- NCT01623219
- Acronym / sponsor ID
- IRB00055554
- Conditions
- Post Traumatic Stress Disorder, PTSD
- Keywords
- PTSD, trauma, combat trauma, veterans, telemedicine, prolonged exposure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (actual)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator proposes to examine treatment for Posttraumatic Stress Disorder for Veterans who served in Iraq and Afghanistan provided through telemedicine which connects patients to doctors in different locations using the internet. In this study, Veterans will receive prolonged exposure therapy (PE). This treatment has been shown to be effective in reducing PTSD symptoms. For this study 9 weekly 90 minute sessions will be given over a period of up to 3 months. The first 2 sessions of each treatment will involve education, rational and treatment preparation. Sessions 3-9 will consist of recounting the traumatic event out loud and repeatedly. The purpose of this study is to determine if this treatment is effective when given through telehealth. To this end, the investigators propose to enroll up to 20 individuals who will access the investigators services through the GA telehealth network who has hundreds of telehealth sites across the state of Georgia. Patients will go to these sites to access the investigators therapists using GA telehealth equipment. The investigators hypothesize that PE delivered remotely through telemedicine will work to reduce the symptoms of PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TeleMedicine Prolonged Exposure | Experimental | Behavioral: Prolonged Exposure TherapyVeterans will receive prolonged exposure therapy (PE)delivered via telemedicine instead of in person. For this study 9 weekly 90 minute sessions will be given over a period of up to 3 months. The first 2 sessions of each treatment will involve education, rational and treatment preparation. Sessions 3-9 will consist of recounting the traumatic event out loud and repeatedly. The purpose of this study is to determine if this treatment is effective when given through telehealth. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must meet DSM-IV criteria for PTSD due to exposure to a trauma while serving in Operation Iraqi Freedom, Operation Enduring Freedom-Afghanistan, and/or Operation New Dawn.
- Patients must be literate in English.
- Patients must be medically healthy or medically stable such that the stress of the therapy is not contraindicated.
- Participants must comprehend his or her role in treatment and the risks involved in order to be entered.
Key exclusion criteria (4 listed)
- Patients with a history of mania, schizophrenia, or other psychoses
- Patients with prominent suicidal ideation
- Patients with current alcohol or drug dependence
- Patients with special medical conditions such as pregnancy, renal insufficiency, those with various chronic diseases or a history of significant head injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged Exposure TherapyAlso: PE, Exposure Therapy, Imaginal ExposureExposure therapy refers to several cognitive behavioral treatment programs that involve confronting feared but safe thoughts, images, objects, situations, or activities in order to reduce unrealistic fear and anxiety. Exposure therapy for PTSD involves prolonged, imaginal exposure to the patient's traumatic memory and in vivo (in real life) exposure to trauma reminders. Prolonged exposure (PE) is a specific exposure therapy program that consists of five components: (1) psychoeducation (2) training in controlled breathing, (3) prolonged imaginal exposure to the trauma memory conducted in therapy sessions and repeated as homework, (4) prolonged in vivo exposure implemented as homework, and (5) processing of the traumatic material to correct maladaptive cognitions. | Behavioural | TeleMedicine Prolonged Exposure |
Primary outcome
CAPS-Clinician Administered PTSD Scale
Time frame: Post-Treatment (10 weeks)
4 secondary outcomes
BDI-II-Beck Depression Inventory-II
Time frame: Post-Treatment (10 weeks)
Credibility/Expectancy Questionnaire-CEQ
Time frame: post treatment (10 weeks)
Client Satisfaction Questionnaire-CSQ
Time frame: post treatment (10 weeks)
PTSD Symptom Scale Self Report-PSS-SR
Time frame: Post-Treatment (10 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara O Rothbaum, PhD, ABPP principal investigator
Emory University, School of Medicine, Dept. of Psychiatry
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure Therapy in people with Post Traumatic Stress Disorder, PTSD, run by Emory University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAPS-Clinician Administered PTSD Scale (time frame: Post-Treatment (10 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.