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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01102764
Enrollment
150
Registered
2010-04-13
Start date
2010-10-31
Completion date
2015-09-30
Last updated
2019-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD

Keywords

Anxiety Disorders: PTSD, Prolong Exposure (PE), Telemedicine, cost effectiveness, deployment related problems, mental health care delivery

Brief 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). ).

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.

Interventions

BEHAVIORALTelemedicine

Prolonged Exposure (PE) therapy provided at patients house via telemedicine

BEHAVIORALIn Person

PE therapy delivered in person at the VAMC

Sponsors

University of Pennsylvania
CollaboratorOTHER
University of Hawaii
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Treatment Completion13 weeksThe 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)26 weeksPTSD 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)26 weeksBeck 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.

Secondary

MeasureTime frameDescription
Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA)14 weeksThe 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.
Treatment Credibility4 weeksThis 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.
Clinician Administered PTSD Scale for DSM-IV (CAPS IV)26 weeksThe 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.
Structured Clinical Interview for DSM-IV (SCID-I)26 weeksThe 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).
Prior Experience With Computer and Audiovisual TechnologyWeek 0The 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.
Service Delivery Perceptions Questionnaire26 weeksThis 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.
Deployment Risk and Resiliency Inventory (DRRI)Week 0The 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.
Health Related Functioning: Medical Outcome Study (MOS) Short Study Forms-36 Health Survey (SF 36)26 weeksThe 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.

Countries

United States

Participant flow

Recruitment details

The research team mailed invitation to participate brochures to a VAMC roster of Veterans of all theatres. IRB-approved recruitment flyers were placed throughout the main hospital and surrounding VA clinics. Furthermore, the team accepted direct referrals from VA providers and the Post Traumatic Stress Disorder Clinical Team (PCT).

Pre-assignment details

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 were analyzed because they completed at least 1 treatment session.

Participants by arm

ArmCount
Arm 1: PE Via Telemedicine
PE via telemedicine Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine
64
Arm 2: PE in Person
PE in person In Person: PE therapy delivered in person at the VAMC
68
Total132

Baseline characteristics

CharacteristicArm 1: PE Via TelemedicineTotalArm 2: PE in Person
Age, Continuous40.7 years
STANDARD_DEVIATION 14.9
41.8 years
STANDARD_DEVIATION 14.5
42.9 years
STANDARD_DEVIATION 14.1
Marital Status
Married
36 participants73 participants37 participants
Marital Status
Never Married
15 participants30 participants15 participants
Marital Status
Separated/Divorced
11 participants23 participants12 participants
Marital Status
Unknown
1 participants3 participants2 participants
Marital Status
Widowed
1 participants3 participants2 participants
Mean Service Connection Rating55.8 units on a scale
STANDARD_DEVIATION 35.7
53.5 units on a scale
STANDARD_DEVIATION 37.9
51.4 units on a scale
STANDARD_DEVIATION 40.2
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
21 Participants44 Participants23 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants8 Participants4 Participants
Race (NIH/OMB)
White
39 Participants80 Participants41 Participants
Region of Enrollment
United States
64 Participants132 Participants68 Participants
Sex: Female, Male
Female
1 Participants5 Participants4 Participants
Sex: Female, Male
Male
63 Participants127 Participants64 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 740 / 76
serious
Total, serious adverse events
0 / 741 / 76

Outcome results

Primary

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.

Time frame: 26 weeks

Population: 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.

ArmMeasureGroupValue (MEAN)
Arm 1: PE Via TelemedicineBeck Depression Inventory-II (BDI-II)Average BDI Score at Baseline28.0 score on a scale
Arm 1: PE Via TelemedicineBeck Depression Inventory-II (BDI-II)Average BDI Score at 1 week Post Tx21.7 score on a scale
Arm 1: PE Via TelemedicineBeck Depression Inventory-II (BDI-II)Average BDI Score at 3 months Post Tx18.3 score on a scale
Arm 1: PE Via TelemedicineBeck Depression Inventory-II (BDI-II)Average BDI Score at 6 months Post Tx21.6 score on a scale
Arm 2: PE in PersonBeck Depression Inventory-II (BDI-II)Average BDI Score at 6 months Post Tx18.4 score on a scale
Arm 2: PE in PersonBeck Depression Inventory-II (BDI-II)Average BDI Score at Baseline27.4 score on a scale
Arm 2: PE in PersonBeck Depression Inventory-II (BDI-II)Average BDI Score at 3 months Post Tx17.6 score on a scale
Arm 2: PE in PersonBeck Depression Inventory-II (BDI-II)Average BDI Score at 1 week Post Tx19.6 score on a scale
Primary

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.

Time frame: 26 weeks

Population: 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.

ArmMeasureGroupValue (MEAN)
Arm 1: PE Via TelemedicinePTSD Checklist-Military (PCL-M)Average PCL Score at Baseline64 score on a scale
Arm 1: PE Via TelemedicinePTSD Checklist-Military (PCL-M)Average PCL Score at 1 week Post Tx48.4 score on a scale
Arm 1: PE Via TelemedicinePTSD Checklist-Military (PCL-M)Average PCL Score at 3 months Post Tx49.2 score on a scale
Arm 1: PE Via TelemedicinePTSD Checklist-Military (PCL-M)Average PCL Score at 6 months Post Tx51.7 score on a scale
Arm 2: PE in PersonPTSD Checklist-Military (PCL-M)Average PCL Score at 6 months Post Tx48.0 score on a scale
Arm 2: PE in PersonPTSD Checklist-Military (PCL-M)Average PCL Score at Baseline61.8 score on a scale
Arm 2: PE in PersonPTSD Checklist-Military (PCL-M)Average PCL Score at 3 months Post Tx46.5 score on a scale
Arm 2: PE in PersonPTSD Checklist-Military (PCL-M)Average PCL Score at 1 week Post Tx44.9 score on a scale
Primary

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.

Time frame: 13 weeks

Population: 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.

ArmMeasureGroupValue (MEAN)
Arm 1: PE Via TelemedicineTreatment CompletionOverall Average Number of Sessions Completed7.6 sessions
Arm 1: PE Via TelemedicineTreatment CompletionAverage Number of Sessions Prior to Dropout3.1 sessions
Arm 2: PE in PersonTreatment CompletionOverall Average Number of Sessions Completed8.6 sessions
Arm 2: PE in PersonTreatment CompletionAverage Number of Sessions Prior to Dropout2.9 sessions
Secondary

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.

Time frame: 14 weeks

Population: 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.

ArmMeasureValue (MEAN)
Arm 1: PE Via TelemedicineCharleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA)65.6 score on a scale
Arm 2: PE in PersonCharleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA)65.5 score on a scale
Secondary

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.

Time frame: 26 weeks

Population: 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.

ArmMeasureGroupValue (MEAN)
Arm 1: PE Via TelemedicineClinician Administered PTSD Scale for DSM-IV (CAPS IV)Mean CAPS Score at Baseline68.4 scores on a scale
Arm 1: PE Via TelemedicineClinician Administered PTSD Scale for DSM-IV (CAPS IV)Mean CAPS Score at 1 Week Post41.9 scores on a scale
Arm 1: PE Via TelemedicineClinician Administered PTSD Scale for DSM-IV (CAPS IV)Mean CAPS Score at 3 Month Post41.0 scores on a scale
Arm 1: PE Via TelemedicineClinician Administered PTSD Scale for DSM-IV (CAPS IV)Mean CAPS Score at 6 Month Post46.8 scores on a scale
Arm 2: PE in PersonClinician Administered PTSD Scale for DSM-IV (CAPS IV)Mean CAPS Score at 6 Month Post41.0 scores on a scale
Arm 2: PE in PersonClinician Administered PTSD Scale for DSM-IV (CAPS IV)Mean CAPS Score at Baseline68.2 scores on a scale
Arm 2: PE in PersonClinician Administered PTSD Scale for DSM-IV (CAPS IV)Mean CAPS Score at 3 Month Post38.7 scores on a scale
Arm 2: PE in PersonClinician Administered PTSD Scale for DSM-IV (CAPS IV)Mean CAPS Score at 1 Week Post41.1 scores on a scale
Secondary

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.

Time frame: Week 0

Population: The outcome data for this measure is not available because there was not enough sufficient responses to generate analyses.

Secondary

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.

Time frame: 26 weeks

Population: 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.

ArmMeasureGroupValue (NUMBER)
Arm 1: PE Via TelemedicineHealth Related Functioning: Medical Outcome Study (MOS) Short Study Forms-36 Health Survey (SF 36)% reported very good/excellent health at Baseline18.60 percentage of participants
Arm 1: PE Via TelemedicineHealth Related Functioning: Medical Outcome Study (MOS) Short Study Forms-36 Health Survey (SF 36)% reported very good/excellent health: 1 week F/U17.90 percentage of participants
Arm 1: PE Via TelemedicineHealth Related Functioning: Medical Outcome Study (MOS) Short Study Forms-36 Health Survey (SF 36)% reported very good/excellent health: 3 mo. F/U15.00 percentage of participants
Arm 1: PE Via TelemedicineHealth Related Functioning: Medical Outcome Study (MOS) Short Study Forms-36 Health Survey (SF 36)% reported very good/excellent health: 6 mo. F/U18.90 percentage of participants
Arm 2: PE in PersonHealth Related Functioning: Medical Outcome Study (MOS) Short Study Forms-36 Health Survey (SF 36)% reported very good/excellent health: 6 mo. F/U22.00 percentage of participants
Arm 2: PE in PersonHealth Related Functioning: Medical Outcome Study (MOS) Short Study Forms-36 Health Survey (SF 36)% reported very good/excellent health at Baseline10.90 percentage of participants
Arm 2: PE in PersonHealth Related Functioning: Medical Outcome Study (MOS) Short Study Forms-36 Health Survey (SF 36)% reported very good/excellent health: 3 mo. F/U12.90 percentage of participants
Arm 2: PE in PersonHealth Related Functioning: Medical Outcome Study (MOS) Short Study Forms-36 Health Survey (SF 36)% reported very good/excellent health: 1 week F/U19.00 percentage of participants
Secondary

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.

Time frame: Week 0

Population: The outcome data for this measure is not available because there was not enough sufficient responses to generate analyses.

Secondary

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.

Time frame: 26 weeks

Population: 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.

ArmMeasureValue (MEAN)
Arm 1: PE Via TelemedicineService Delivery Perceptions Questionnaire4.6 units on a scale
Arm 2: PE in PersonService Delivery Perceptions Questionnaire4.7 units on a scale
Secondary

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).

Time frame: 26 weeks

Population: 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.

ArmMeasureGroupValue (NUMBER)
Arm 1: PE Via TelemedicineStructured Clinical Interview for DSM-IV (SCID-I)Base SCID % Depression DX75.6 percentage of participants
Arm 1: PE Via TelemedicineStructured Clinical Interview for DSM-IV (SCID-I)Post SCID % Depression DX66.7 percentage of participants
Arm 1: PE Via TelemedicineStructured Clinical Interview for DSM-IV (SCID-I)Month 3 SCID % Depression DX58.3 percentage of participants
Arm 1: PE Via TelemedicineStructured Clinical Interview for DSM-IV (SCID-I)Month 6 SCID % Depression DX62.5 percentage of participants
Arm 1: PE Via TelemedicineStructured Clinical Interview for DSM-IV (SCID-I)Base SCID % Panic DX30.0 percentage of participants
Arm 1: PE Via TelemedicineStructured Clinical Interview for DSM-IV (SCID-I)Post SCID % Panic DX50 percentage of participants
Arm 1: PE Via TelemedicineStructured Clinical Interview for DSM-IV (SCID-I)Month 3 SCID % Panic DX40 percentage of participants
Arm 1: PE Via TelemedicineStructured Clinical Interview for DSM-IV (SCID-I)Month 6 SCID % Panic DX38.5 percentage of participants
Arm 2: PE in PersonStructured Clinical Interview for DSM-IV (SCID-I)Month 6 SCID % Panic DX53.8 percentage of participants
Arm 2: PE in PersonStructured Clinical Interview for DSM-IV (SCID-I)Base SCID % Depression DX86.5 percentage of participants
Arm 2: PE in PersonStructured Clinical Interview for DSM-IV (SCID-I)Base SCID % Panic DX33.0 percentage of participants
Arm 2: PE in PersonStructured Clinical Interview for DSM-IV (SCID-I)Post SCID % Depression DX52.9 percentage of participants
Arm 2: PE in PersonStructured Clinical Interview for DSM-IV (SCID-I)Month 3 SCID % Panic DX20 percentage of participants
Arm 2: PE in PersonStructured Clinical Interview for DSM-IV (SCID-I)Month 3 SCID % Depression DX40.0 percentage of participants
Arm 2: PE in PersonStructured Clinical Interview for DSM-IV (SCID-I)Post SCID % Panic DX28 percentage of participants
Arm 2: PE in PersonStructured Clinical Interview for DSM-IV (SCID-I)Month 6 SCID % Depression DX42.1 percentage of participants
Secondary

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.

Time frame: 4 weeks

Population: 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.

ArmMeasureValue (MEAN)
Arm 1: PE Via TelemedicineTreatment Credibility4.4 scores on a scale
Arm 2: PE in PersonTreatment Credibility4.5 scores on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026