PTSDNCT01102764

Prolonged Exposure (PE) for Post Traumatic Stress Disorder (PTSD): Telemedicine Versus In Person

A study testing Telemedicine and In Person in people with PTSD, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The present proposal is to study whether Prolonged Exposure (PE) delivered via Telemedicine is as effective as PE delivered In Person for Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF) Veterans and Veterans of all theatres, particularly Vietnam era with Post-Traumatic Stress Disorder (PTSD). ). Read more about this study

Who is it for?: Ages 21 to 99 years
Conditions the study is for: PTSD
What is being tested?: Telemedicine and In Person
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteUnited States
Study dates: Oct 2010to Sep 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants will be 226 male and female:
Operation Iraqi Freedom, Operation Enduring Freedom (OIF OEF) Veterans, and Veterans of all theatres, particularly Vietnam era Veterans.
age 21 and above, and
diagnosed via structured clinical interview with PTSD

Who cannot join

Actively psychotic or demented persons,
individuals with both suicidal ideation and clear intent, and
individuals meeting full criteria for substance dependence will be excluded from participation

Trial locations and contacts

1 site in 1 country.

United States1 site

Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5799

Other trials in United States

About this study

Official title: Prolonged Exposure (PE) for PTSD: Telemedicine vs. In Person

Read the detailed description

Project Background/Rationale: Approximately 15 to 17% of current Iraq war Veterans meet full diagnostic criteria for MH problems such as post-traumatic stress disorder (PTSD) (Hoge et al., 2004). Prolonged Exposure (PE) is an empirically supported treatment for PTSD (Foa 1997; Schnurr et al., 2007), and has been adopted by the Department of Veterans Affairs (DOVA) as one of the treatments of choice for the disorder, as evident by the DOVA-sponsored national training of clinicians to use PE. It is therefore important to employ treatment delivery methods that maximize the likelihood that all Veterans in need, including Veterans residing in rural settings, and Veterans who avoid DOVA settings due to the stigma of receiving mental health treatment, will receive interventions such as PE. The May, 2005 Committee on Veterans Affairs, Subcommittee on Health has identified Telemedicine as a DOVA priority area to address this need. The present proposal is to study whether PE delivered via Telemedicine is as effective as PE delivered In Person. Telemedicine has been chosen for its ability to overcome what appear to be two major barriers to mental health care (Frueh et al., 2000): the difficulty that rural-residing Veterans face in reaching VAMC facilities, and the stigma Veterans perceive related to receiving mental health treatment. Indeed, if effective, PE delivered via telemedicine may address the problem inherent in the finding that 42% of those screening positive for PTSD indicate that they are interested in receiving help, but only 25% actually receive services (Hoge, et al., 2006).

Project Objectives: Although effective treatments for PTSD exist and have been adopted by the Veterans Affairs Medical Centers (VAMC), barriers to care of a social (e.g., stigma) and geographic (e.g., rural) nature prevent many Veterans in need from receiving care. Telemedicine might address this need. The major objective of this study is to determine if PE delivered via Telemedicine is as effective as In Person PE in terms of (1) clinical; (2) process; and (3) economic outcomes.

Project Methods: The investigators propose to use a randomized between groups repeated measures (baseline, post-treatment, 3\& 6-month followups) design with 226 OIF-OEF Veterans diagnosed with PTSD to assess the relative effectiveness, measured in terms of symptoms, patient satisfaction, and costs, of PE delivered via Telemedicine vs. In Person formats. The investigators hypothesize that no differences (i.e., non-inferiority) between the two formats will be evident in terms treatment gains, patient satisfaction, treatment attrition, patient satisfaction and direct health care costs.

Anticipated Impacts on Veterans Health care: This study will provide important information regarding whether PE delivered via home-based Telemedicine equipment is as effective as traditional In Person delivery of PE for post-traumatic stress disorder. If shown to be as effective as In Person treatment, a new, innovative, and cost effective intervention delivery system for PTSD will have initial empirical support.

Conditions: PTSD
Being tested: Telemedicine, In Person
Keywords: Anxiety Disorders: PTSD, Prolong Exposure (PE), Telemedicine, cost effectiveness, deployment related problems, mental health care delivery
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TelemedicineBehavioural
Prolonged Exposure (PE) therapy provided at patients house via telemedicine
In PersonBehavioural
PE therapy delivered in person at the VAMC

Study groups in NCT01102764
Study group	Role	What they receive
Arm 1: PE via telemedicine	Experimental	PE via telemedicine Receives: Behavioral: Telemedicine
Arm 2: PE in person	Active comparator	PE in person Receives: Behavioral: In Person

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment Completion
The major objective of this study is to determine if PE delivered via Telemedicine is as effective as In Person PE in terms of (1) clinical (PTSD and Depression); (2) process (Treatment Satisfaction and Attrition); and (3) economic (Cost) outcomes. Per protocol, participants could have as many as 12 treatment sessions. Per protocol treatment completers completed at least 6 90-minute sessions of Prolonged Exposure either In Person or via Telemedicine. Treatment dropout is defined as initiating treatment but completing fewer than 6 sessions.
Measured: 13 weeks
PTSD Checklist-Military (PCL-M)
PTSD Checklist-Military (PCL-M): The PCL is a 17 Item Self Report Measure of PTSD Symptoms Based on the DSM-IV Criteria. The PCL uses a 5-point Likert scale response format ranging from not at all to frequently. The instrument is highly correlated with the Clinician Administered PTSD Scale (r = .93), has good diagnostic efficiency (> .70), and robust psychometrics with a variety of trauma populations (Blanchard, 1996), including combat veterans (Magruder, Frueh, et al, 2005). Total scores on the PCL range from 17 to 85, with lower scores indicating less symptom severity.
Measured: 26 weeks
Beck Depression Inventory-II (BDI-II)
Beck Depression Inventory-II (BDI-II): (BDI; Beck et al., 1961): The BDI-II is a 21-item self-report scale, is among the most widely used instruments to measure depression. Beck and Steer (1984) demonstrated that the BDI-I has high internal consistency (α = .86 - .91). Lower scores indicate less symptom severity, and higher scores indicate more severe depressive symptoms. Raw scores of 0-13 indicates minimal depression; 14-19 indicates mild depression; 20-28 indicates moderate depression; 29-63 indicates severe depression. The lowest possible score on this measure is 0, and the highest possible score is 63.
Measured: 26 weeks

Secondary outcomes (8)

Clinician Administered PTSD Scale for DSM-IV (CAPS IV)
The Clinician Administered PTSD Scale (CAPS) is a structured interview designed to make a categorical PTSD diagnosis, as well as to provide a measure of PTSD symptom severity. The structure corresponds to the DSM-IV criteria for PTSD diagnoses, with B, C, and D symptoms rated for both frequency and intensity; these two scores (frequency + intensity) are summed to provide severity ratings. Additional questions assess Criteria A, E, and F. It is recommended that the "1, 2" rule be used to determine whether a symptom meets criteria; that is, a frequency score of at least 1 (scale 0 = "none of the time" to 4 = "most or all of the time") and an intensity score of at least 2 (scale 0 = "none" to 4 = "extreme") is required for a particular symptom to meet criteria. Total scores from B, C and D range from 0 to 136, with lower scores indicating better outcomes, and higher scores indicating worse outcomes.
Measured: 26 weeks
Deployment Risk and Resiliency Inventory (DRRI)
The DRRI is collection of self-report measures assessing 14 key deployment-related risk and resilience factors with demonstrated implications for veterans' long-term health. With the nature of military deployment changing, with a larger proportion of women, National Guard and Reserves being deployed for more contemporary conflicts, the DRRI was developed to provide a more comprehensive assessment of the current combat-related experiences. The DRRI is made up of multiple scales to represent different constructs. Responses are either dichotomous (0=No, 1=Yes), polytomous (0=No, 1=Not Sure, 2=Yes), or recorded on a 4, 5 or 6 point Likert scales. Scores for each section are summed are contain scoring ranges. Higher scores are indicative of worse outcomes.
Measured: Week 0
Health Related Functioning: Medical Outcome Study (MOS) Short Study Forms-36 Health Survey (SF 36)
The MOS SF-36 is an indicator of overall health status. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each of the eight summed scores is linearly transformed onto a scale from 0 (negative health) to 100 (positive health) to provide a score for each subscale. Therefore, lower scores indicate more disability while higher scores indicate less disability. Each subscale can be used independently. Sections of the SF-36 include: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health.
Measured: 26 weeks
Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA)
The CPOSS is a 16-item measure, with a Likert scale response format, based on a general measure of patient satisfaction. Extant data demonstrate that the measure has excellent reliability (alpha = 0.96) and good convergent validity with relevant anchor items ("would you recommend this treatment to a friend or family member?"). Items are scored using a 5 point Likert scale (5=excellent; 4=very good; 3=good; 2=fair; 1=poor). The scale is scored by summing the scores of all individual items. The possible range is 16 to 80, with higher scores indicating higher satisfaction.
Measured: 14 weeks
Treatment Credibility
This measures assesses for differences in outcome expectancy. The Treatment Credibility Scale (as used in this study) contains 4 questions. Each question is scored individually via 10-point Likert scales. Questions asses how logical treatment seems, how confident participants are about treatment, and expectations of success and is administered at treatment session 4. Scores on treatment logicality, confidence and predicted success on each question range from 1 (not at all) to 10 (very logical), with mid-range scores indicating moderate logicality, confidence and predicted success.
Measured: 4 weeks
Service Delivery Perceptions Questionnaire
This measure is used to assess Veterans' perceptions about variables specifically related to this mode of service delivery (e.g., the quality of communication, ease of use, and willingness to use treatment via videoconferencing in the future). There are 8 questions (1 question was not assessed due to asking about group participation which is irrelevant to the current study). All questions are answered via a 5 point Likert scale, with 1 indicating poor perceptions and 5 indicating excellent perceptions. Scores range from 7-35, with higher scores indicating more positive outcomes.
Measured: 26 weeks
Structured Clinical Interview for DSM-IV (SCID-I)
The Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) is a semistructured interview to determine whether an individual meets criteria for any Axis I disorder in the Diagnostic and Statistical Manual of Mental Disorders (version IV). The SCID is broken down into separate modules corresponding to categories of diagnoses, and uses skip logic to allow the interviewer to skip questions or modules if certain diagnostic criteria are indicated. Most sections begin with an entry question that would allow the interviewer to "skip" the associated questions if not met. For all diagnoses symptoms are coded as present, subthreshold, or absent. It assesses for both current and lifetime diagnoses and prompts the interviewer to document age of illness onset and to rate current illness severity (Glasofer et al., 2015).
Measured: 26 weeks
Prior Experience With Computer and Audiovisual Technology
The Prior Experience With Technology questionnaire is an 8-item short measure to learn more about participants' prior experiences and comfort level with computers and audiovisual technology. For 8 different technological devices, the measure asks if the participant has the device in his/her home (i.e. Is there a telephone in your home)? Subsequent questions determine whether the patient is comfortable using that device or, if he/she does not own one, if he/she would be willing to learn to use one. Devices assessed include telephone, television, stereo, video player (e.g. VCR, DVD), computer, internet, e-mail, and audiovisual conferencing technology. These data may help identify whether these variables are associated with clinical outcome.
Measured: Week 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010Sep 2015

First posted13 Apr 2010 (estimated)
Study startOct 2010
Primary completionJun 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (20)Papers the sponsor has linked to this study.
Other trials for PTSDStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01102764
Sponsor's protocol ID: IAC 09-040
Other IDs: 19695
Status last verified: Nov 2018
First submitted: 17 Mar 2010
Last updated: 4 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Strachan M, Gros DF, Yuen E, Ruggiero KJ, Foa EB, Acierno R. Home-based telehealth to deliver evidence-based psychotherapy in veterans with PTSD. Contemp Clin Trials. 2012 Mar;33(2):402-9. doi: 10.1016/j.cct.2011.11.007. Epub 2011 Nov 11.
PubMed 22101225
Gros DF, Price M, Strachan M, Yuen EK, Milanak ME, Acierno R. Behavioral activation and therapeutic exposure: an investigation of relative symptom changes in PTSD and depression during the course of integrated behavioral activation, situational exposure, and imaginal exposure techniques. Behav Modif. 2012 Jul;36(4):580-99. doi: 10.1177/0145445512448097. Epub 2012 Jun 7.
PubMed 22679240
Tuerk PW, Wangelin B, Rauch SA, Dismuke CE, Yoder M, Myrick H, Eftekhari A, Acierno R. Health service utilization before and after evidence-based treatment for PTSD. Psychol Serv. 2013 Nov;10(4):401-9. doi: 10.1037/a0030549. Epub 2012 Nov 12.
PubMed 23148769
Price M, Gros DF, Strachan M, Ruggiero KJ, Acierno R. The Role of Social Support in Exposure Therapy for Operation Iraqi Freedom/Operation Enduring Freedom Veterans: A Preliminary Investigation. Psychol Trauma. 2013 Jan 1;5(1):93-100. doi: 10.1037/a0026244.
PubMed 23869250
Gros DF, Gros K, Acierno R, Frueh BC, Moreland L. Relation between treatment satisfaction and treatment outcome in veterans with posttraumatic stress disorder. Journal of psychopathology and behavioral assessment. 2013 Jun 28; 35(4):522-30.
Acierno R, Gros DF, Morland L, Greene C, Strachan MK, Egede LE, Tuerk PW, Frueh BC, Myrick H. Delivery of evidence-based psychotherapy via video telehealth. Journal of psychopathology and behavioral assessment. 2013 Dec 1; 35(4):506-521.
Gros DF, Price M, Yuen EK, Acierno R. Predictors of completion of exposure therapy in OEF/OIF veterans with posttraumatic stress disorder. Depress Anxiety. 2013 Nov;30(11):1107-13. doi: 10.1002/da.22207. Epub 2013 Oct 21.
PubMed 24151141
Soltis K, Acierno R, Gros DF, Yoder M, Tuerk PW. Post-traumatic stress disorder: ethical and legal relevance to the criminal justice system. J Law Med Ethics. 2014 Summer;42(2):147-54. doi: 10.1111/jlme.12130.
PubMed 25040378
Paul LA, Gros DF, Strachan M, Worsham G, Foa EB, Acierno R. Prolonged Exposure for Guilt and Shame in a Veteran of Operation Iraqi Freedom. Am J Psychother. 2014 Sep 1;68(3):277-286. doi: 10.1176/appi.psychotherapy.2014.68.3.277.
PubMed 25505798
Hernandez-Tejada MA, Zoller JS, Ruggiero KJ, Kazley AS, Acierno R. Early treatment withdrawal from evidence-based psychotherapy for PTSD: telemedicine and in-person parameters. Int J Psychiatry Med. 2014;48(1):33-55. doi: 10.2190/PM.48.1.d.
PubMed 25354925
Yuen EK, Gros DF, Price M, Zeigler S, Tuerk PW, Foa EB, Acierno R. Randomized Controlled Trial of Home-Based Telehealth Versus In-Person Prolonged Exposure for Combat-Related PTSD in Veterans: Preliminary Results. J Clin Psychol. 2015 Jun;71(6):500-12. doi: 10.1002/jclp.22168. Epub 2015 Mar 25.
PubMed 25809565
Badour CL, Gros DF, Szafranski DD, Acierno R. Problems in sexual functioning among male OEF/OIF veterans seeking treatment for posttraumatic stress. Compr Psychiatry. 2015 Apr;58:74-81. doi: 10.1016/j.comppsych.2014.12.012. Epub 2014 Dec 30.
PubMed 25596624
Zhang J, Sheerin C, Mandel H, Banducci AN, Myrick H, Acierno R, Amstadter AB, Wang Z. Variation in SLC1A1 is related to combat-related posttraumatic stress disorder. J Anxiety Disord. 2014 Dec;28(8):902-7. doi: 10.1016/j.janxdis.2014.09.013. Epub 2014 Oct 5.
PubMed 25445080
Pelton D, Wangelin B, Tuerk P. Utilizing Telehealth to Support Treatment of Acute Stress Disorder in a Theater of War: Prolonged Exposure via Clinical Videoconferencing. Telemed J E Health. 2015 May;21(5):382-7. doi: 10.1089/tmj.2014.0111. Epub 2015 Mar 12.
PubMed 25764266
Tuerk PW. Starting from something: augmenting exposure therapy and methods of inquiry. Am J Psychiatry. 2014 Oct;171(10):1034-7. doi: 10.1176/appi.ajp.2014.14070880. No abstract available.
PubMed 25272341

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prolonged Exposure (PE) for PTSD: Telemedicine vs. In Person
ClinicalTrials.gov ID: NCT01102764
Acronym / sponsor ID: IAC 09-040
Conditions: PTSD
Keywords: Anxiety Disorders: PTSD, Prolong Exposure (PE), Telemedicine, cost effectiveness, deployment related problems, mental health care delivery
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: University of Pennsylvania, University of Hawaii
Study start: Oct 2010
Primary completion: Jun 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 13 Apr 2010 (estimated)
Results: Posted 1 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arm 1: PE via telemedicine	Experimental	Behavioral: TelemedicinePE via telemedicine
Arm 2: PE in person	Active comparator	Behavioral: In PersonPE in person

Who may qualify

Ages: 21 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Operation Iraqi Freedom, Operation Enduring Freedom (OIF OEF) Veterans, and Veterans of all theatres, particularly Vietnam era Veterans.
age 21 and above, and
diagnosed via structured clinical interview with PTSD

Key exclusion criteria (3 listed)

Actively psychotic or demented persons,
individuals with both suicidal ideation and clear intent, and
individuals meeting full criteria for substance dependence will be excluded from participation

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
TelemedicineProlonged Exposure (PE) therapy provided at patients house via telemedicine	Behavioural	Arm 1: PE via telemedicine
In PersonPE therapy delivered in person at the VAMC	Behavioural	Arm 2: PE in person

Primary outcome

Treatment Completion
Time frame: 13 weeks
The major objective of this study is to determine if PE delivered via Telemedicine is as effective as In Person PE in terms of (1) clinical (PTSD and Depression); (2) process (Treatment Satisfaction and Attrition); and (3) economic (Cost) outcomes. Per protocol, participants could have as many as 12 treatment sessions. Per protocol treatment completers completed at least 6 90-minute sessions of Prolonged Exposure either In Person or via Telemedicine. Treatment dropout is defined as initiating treatment but completing fewer than 6 sessions.
PTSD Checklist-Military (PCL-M)
Time frame: 26 weeks
PTSD Checklist-Military (PCL-M): The PCL is a 17 Item Self Report Measure of PTSD Symptoms Based on the DSM-IV Criteria. The PCL uses a 5-point Likert scale response format ranging from not at all to frequently. The instrument is highly correlated with the Clinician Administered PTSD Scale (r = .93), has good diagnostic efficiency (> .70), and robust psychometrics with a variety of trauma populations (Blanchard, 1996), including combat veterans (Magruder, Frueh, et al, 2005). Total scores on the PCL range from 17 to 85, with lower scores indicating less symptom severity.
Beck Depression Inventory-II (BDI-II)
Time frame: 26 weeks
Beck Depression Inventory-II (BDI-II): (BDI; Beck et al., 1961): The BDI-II is a 21-item self-report scale, is among the most widely used instruments to measure depression. Beck and Steer (1984) demonstrated that the BDI-I has high internal consistency (α = .86 - .91). Lower scores indicate less symptom severity, and higher scores indicate more severe depressive symptoms. Raw scores of 0-13 indicates minimal depression; 14-19 indicates mild depression; 20-28 indicates moderate depression; 29-63 indicates severe depression. The lowest possible score on this measure is 0, and the highest possible score is 63.

8 secondary outcomes

Clinician Administered PTSD Scale for DSM-IV (CAPS IV)
Time frame: 26 weeks
Deployment Risk and Resiliency Inventory (DRRI)
Time frame: Week 0
Health Related Functioning: Medical Outcome Study (MOS) Short Study Forms-36 Health Survey (SF 36)
Time frame: 26 weeks
Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA)
Time frame: 14 weeks
Treatment Credibility
Time frame: 4 weeks
Service Delivery Perceptions Questionnaire
Time frame: 26 weeks
Structured Clinical Interview for DSM-IV (SCID-I)
Time frame: 26 weeks
Prior Experience With Computer and Audiovisual Technology
Time frame: Week 0

Results and safety

Results posted to the registry on 1 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: PE Via Telemedicine	64	43
Arm 2: PE in Person	68	55

Primary outcome: Treatment Completion

Time frame: 13 weeks. Mean (Full Range). Unit: sessions

Measure	Arm 1: PE Via Telemedicine n = 64	Arm 2: PE in Person n = 68
Overall Average Number of Sessions Completed	7.6 (1 to 12)	8.6 (1 to 12)
Average Number of Sessions Prior to Dropout	3.1 (1 to 12)	2.9 (1 to 12)

Population analysed: There were 150 participants enrolled in the study, and 132 completed at least one session and were thus analyzed. The numbers here reflect those participants who completed at least one session.

Primary outcome: PTSD Checklist-Military (PCL-M)

Time frame: 26 weeks. Mean (Full Range). Unit: score on a scale

Measure	Arm 1: PE Via Telemedicine n = 64	Arm 2: PE in Person n = 68
Average PCL Score at Baseline	64 (17.0 to 85.0)	61.8 (17.0 to 85.0)
Average PCL Score at 1 week Post Tx	48.4 (17.0 to 85.0)	44.9 (17.0 to 85.0)
Average PCL Score at 3 months Post Tx	49.2 (17.0 to 85.0)	46.5 (17.0 to 85.0)
Average PCL Score at 6 months Post Tx	51.7 (17.0 to 85.0)	48.0 (17.0 to 85.0)

Primary outcome: Beck Depression Inventory-II (BDI-II)

Time frame: 26 weeks. Mean (Full Range). Unit: score on a scale

Measure	Arm 1: PE Via Telemedicine n = 64	Arm 2: PE in Person n = 68
Average BDI Score at Baseline	28.0 (0.0 to 63.0)	27.4 (0.0 to 63.0)
Average BDI Score at 1 week Post Tx	21.7 (0.0 to 63.0)	19.6 (0.0 to 63.0)
Average BDI Score at 3 months Post Tx	18.3 (0.0 to 63.0)	17.6 (0.0 to 63.0)
Average BDI Score at 6 months Post Tx	21.6 (0.0 to 63.0)	18.4 (0.0 to 63.0)

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: PE Via Telemedicine	0 of 74 (0%)	0 of 74 (0%)	Not reported
Arm 2: PE in Person	1 of 76 (1.3%)	0 of 76 (0%)	Not reported

Limitations and caveats (from the sponsor): 1. The study lacked a third group of participants receiving an alternative intervention to compare PE-HBT with a standard control-group. 2. The achieved effect sizes were less than those typically evident in PE treatment outcome studies

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22101225Strachan M, Gros DF, Yuen E, Ruggiero KJ, Foa EB, Acierno R. Home-based telehealth to deliver evidence-based psychotherapy in veterans with PTSD. Contemp Clin Trials. 2012 Mar;33(2):402-9. doi: 10.1016/j.cct.2011.11.007. Epub 2011 Nov 11.
Background: PubMed 22679240Gros DF, Price M, Strachan M, Yuen EK, Milanak ME, Acierno R. Behavioral activation and therapeutic exposure: an investigation of relative symptom changes in PTSD and depression during the course of integrated behavioral activation, situational exposure, and imaginal exposure techniques. Behav Modif. 2012 Jul;36(4):580-99. doi: 10.1177/0145445512448097. Epub 2012 Jun 7.
Background: PubMed 23148769Tuerk PW, Wangelin B, Rauch SA, Dismuke CE, Yoder M, Myrick H, Eftekhari A, Acierno R. Health service utilization before and after evidence-based treatment for PTSD. Psychol Serv. 2013 Nov;10(4):401-9. doi: 10.1037/a0030549. Epub 2012 Nov 12.
Background: PubMed 23869250Price M, Gros DF, Strachan M, Ruggiero KJ, Acierno R. The Role of Social Support in Exposure Therapy for Operation Iraqi Freedom/Operation Enduring Freedom Veterans: A Preliminary Investigation. Psychol Trauma. 2013 Jan 1;5(1):93-100. doi: 10.1037/a0026244.
BackgroundGros DF, Gros K, Acierno R, Frueh BC, Moreland L. Relation between treatment satisfaction and treatment outcome in veterans with posttraumatic stress disorder. Journal of psychopathology and behavioral assessment. 2013 Jun 28; 35(4):522-30.
BackgroundAcierno R, Gros DF, Morland L, Greene C, Strachan MK, Egede LE, Tuerk PW, Frueh BC, Myrick H. Delivery of evidence-based psychotherapy via video telehealth. Journal of psychopathology and behavioral assessment. 2013 Dec 1; 35(4):506-521.
Background: PubMed 24151141Gros DF, Price M, Yuen EK, Acierno R. Predictors of completion of exposure therapy in OEF/OIF veterans with posttraumatic stress disorder. Depress Anxiety. 2013 Nov;30(11):1107-13. doi: 10.1002/da.22207. Epub 2013 Oct 21.
Background: PubMed 25040378Soltis K, Acierno R, Gros DF, Yoder M, Tuerk PW. Post-traumatic stress disorder: ethical and legal relevance to the criminal justice system. J Law Med Ethics. 2014 Summer;42(2):147-54. doi: 10.1111/jlme.12130.
Background: PubMed 25505798Paul LA, Gros DF, Strachan M, Worsham G, Foa EB, Acierno R. Prolonged Exposure for Guilt and Shame in a Veteran of Operation Iraqi Freedom. Am J Psychother. 2014 Sep 1;68(3):277-286. doi: 10.1176/appi.psychotherapy.2014.68.3.277.
Background: PubMed 25354925Hernandez-Tejada MA, Zoller JS, Ruggiero KJ, Kazley AS, Acierno R. Early treatment withdrawal from evidence-based psychotherapy for PTSD: telemedicine and in-person parameters. Int J Psychiatry Med. 2014;48(1):33-55. doi: 10.2190/PM.48.1.d.
Background: PubMed 25809565Yuen EK, Gros DF, Price M, Zeigler S, Tuerk PW, Foa EB, Acierno R. Randomized Controlled Trial of Home-Based Telehealth Versus In-Person Prolonged Exposure for Combat-Related PTSD in Veterans: Preliminary Results. J Clin Psychol. 2015 Jun;71(6):500-12. doi: 10.1002/jclp.22168. Epub 2015 Mar 25.
Background: PubMed 25596624Badour CL, Gros DF, Szafranski DD, Acierno R. Problems in sexual functioning among male OEF/OIF veterans seeking treatment for posttraumatic stress. Compr Psychiatry. 2015 Apr;58:74-81. doi: 10.1016/j.comppsych.2014.12.012. Epub 2014 Dec 30.
Click here for more information about this study: Prolonged Exposure (PE) for PTSD: Telemedicine vs. In PersonLink provided by the sponsor.

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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.

Ron E. Acierno, PhD MS BA principal investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine and In Person in people with PTSD, run by VA Office of Research and Development at 1 site in United States.

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 3 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: finished, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 1 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Treatment Completion (time frame: 13 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01102764, which also lists 20 linked publications.

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 4 Mar 2019.