Posttraumatic Stress DisorderNCT03110302
In-Home Exposure Therapy for Veterans With Post Traumatic Stress Disorder (PTSD)
A study testing Prolonged exposure in people with Posttraumatic Stress Disorder, run by Veterans Medical Research Foundation at 1 site in United States.
Trial summary
This study examines clinical and process outcomes following variable length prolonged exposure (PE) for posttraumatic stress disorder (PTSD) delivered by one of three treatment modalities: home-based telehealth (HBT), office-based telehealth (OBT), or in-home-in-person (IHIP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Prolonged exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jul 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Military Veterans enrolled in a program at VASDHS;
- primary diagnosis of PTSD as a consequence of any index traumatic event. The diagnosis will include a clear memory of the traumatic event and the 17 other core symptoms of PTSD from the DSM-IV. Note that comorbid mood and anxiety disorders are expected and will be permitted (to maximize generalizability) if PTSD symptoms are judged to be predominant based on primacy and severity of symptoms. The proposed treatment often concurrently ameliorates depression and anxiety symptoms;
- age 18 or older; and
- Primary residence within 35 miles of the center point of La Jolla, CA center (to make therapist travel to home sites feasible for this project). This will include the major cities of San Diego, Chula Vista (23 miles Southeast; 30 minutes), La Mesa (19 miles East; 25 minutes), Coronado (18 miles South; 30 minutes), Oceanside (36 miles Southeast; 39 minutes), Escondido (27 miles northeast; 35 minutes) and San Ysidro (28 miles South; 32 minutes).
Who cannot join
- unmanaged dementia, psychosis or manic episodes in past year (assessed by phone screen, chart review, and clinician judgment);
- substance or alcohol dependence in past 60 days (as assessed by the Alcohol Use Disorders Identification Test [AUDIT]);
- concurrent psychotherapies targeting PTSD (Veterans who are engaged in treatment for non PTSD symptoms, such as 12-step programs for substance problems or couples therapy for relationship issues, will remain eligible); and
- severe physical disease or disorder (e.g., cardiovascular or respiratory disease; severe impairments in speech, vision, or hearing) that would make it difficult to ensure regular attendance at psychotherapy sessions or would significantly impede learning (as assessed during phone screen discussion with potential participants). Potential participants who have had changes in the type and dosage of psychotropic medications in the preceding 60 days will be asked to wait until their medication regimen has stabilized to minimize treatment confounds. Psychotropic medication use will also be monitored to determine whether random assignment to treatment conditions resulted in unequal rates of use. As recommended by Bradley and colleagues, individuals with suicidal ideation will not be excluded from the study a priori, but rather suicidal urges or plans will be assessed throughout the study and appropriately addressed (by intervention or referral). The depression measure (the BDI-II) assesses suicidality explicitly (item 9). Dr. Thorp has extensive experience working with suicidal individuals and teaching crisis management skills, and the other study therapists will be trained in these skills as well.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System
San Diego, California, 92161
About this study
This study examines clinical and process outcomes following variable length prolonged exposure (PE) for posttraumatic stress disorder (PTSD) delivered by one of three treatment modalities: home-based telehealth (HBT), office-based telehealth (OBT), or in-home-in-person (IHIP).
Read the detailed description
This study will provide a certain type of exposure therapy, called prolonged exposure therapy (PE), to military Veterans with Post Traumatic Stress Disorder (PTSD). One hundred and seventy-five Veterans will participate in the study. The main study goal is to compare PE conducted in three different ways: (1) PE that is office-based (OB; Veterans come to a VA clinic and meet with a therapist via telehealth, using videoconferencing technology), (2) PE delivered via home-based telehealth (HBT; Veterans stay at home and meet with the therapist via telehealth, using videoconferencing technology), and (3) PE delivered in home, in person (IHIP; the therapist goes to the Veterans' homes to provide the psychotherapy). Symptoms of PTSD, depression, and anxiety will be examined at pre-treatment, post-treatment and at six-month follow up to determine if symptoms change over time. Study hypotheses state that the IHIP approach, compared to the other two approaches, will be more effective at reducing the PTSD symptoms experienced by these Veterans because it will help Veterans attend each session and complete the therapy "homework" assigned by the therapists (such as doing feared, but safe, activities around the house or the neighborhood). However, the delivery of IHIP may cost more than the delivery of PE via the other modalities.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Prolonged exposure
- Keywords
- Posttraumatic Stress Disorder, Telehealth, Video teleconferencing, In home therapy, Prolonged Exposure
- 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.
Prolonged exposureBehavioural
Also called PE
PE is a manualized treatment developed by Dr. Edna Foa and her colleagues. In all three treatment modalities, 7-15 weekly, 90 minute individual sessions of PE will be provided. PE is based on emotional processing theory, which proposes that avoidance and negative thoughts about the self and the world maintain PTSD symptoms over time. According to emotional processing theory, effective treatment requires repeated activation of the trauma memory (as through memory and in vivo exposure) and incorporation of corrective information into the trauma fear structure. PE has several primary components: (1) psychoeducation about PTSD and avoidance; (2) imaginal exposure with processing, wherein the participant describes the traumatic memory aloud many times and discusses it with the therapist afterward; and (3) in-vivo exposure, wherein the participant engages in feared, but safe, activities that have been avoided since the traumatic event (e.g., crowded places, driving).
| Study group | Role | What they receive |
|---|---|---|
| Office-based telehealth (OBT) | Active comparator | Veterans come to a VA clinic and meet with a therapist via telehealth, using videoconferencing technology Receives: Behavioral: Prolonged exposure |
| Home-based telehealth (HBT) | Active comparator | Veterans stay at home and meet with the therapist via telehealth, using videoconferencing technology Receives: Behavioral: Prolonged exposure |
| In home, in person (IHIP) | Experimental | Therapist goes to the Veterans' homes to provide the psychotherapy Receives: Behavioral: Prolonged exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
The CAPS is a clinician-administered interview that assesses PTSD severity and diagnostic threshold. CAPS questions are designed to assess DSM-5 PTSD diagnostic criteria. CAPS has become the "gold standard" semistructured interview for assessing PTSD in the general population.
Measured: From baseline to 9 months
Secondary outcomes (5)
Change in Beck Depression Inventory (BDI-II)
The BDI is a well-established, 21-item self-report inventory designed to measure depressive symptomatology, including suicidality.
Measured: From baseline to 9 months
Change in PTSD Checklist (PCL-5)
The PCL-5 is a gold-standard self-report questionnaire designed to assess PTSD symptom severity; there are 20 questions.
Measured: From baseline to 9 months
Change in Client Satisfaction Questionnaire (CSQ) - Short form
This well-validated questionnaire consists of 8 items rated on a 5-point Likert scale ranging from "Not at all" to "Very much" and one free response question. The CSQ is designed to measure patient satisfaction with interpersonal and communication behaviors.
Measured: From baseline to 3 months
Change in Therapist Satisfaction Questionnaire (TSQ)
The TSQ is a validated instrument filled out by the therapist and used to measure provider satisfaction with therapy. This questionnaire consists of 20 items that are rated on a 5-point likert scale raning from "Strongly agree" to "Strongly disagree."
Measured: From baseline to 3 months
Change in Working Alliance Inventory - Short form (WAI-S)
The WAI measures therapeutic alliance between the therapist and patient. Both the patient and the therapist fill out the WAI. This 12-item inventory has 3 subscales: (1) Goals (agreement about therapy goals), (2) Tasks (agreement about issues to be worked on), and (3) Bonds (comfort level between participant and therapist).
Measured: From baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study startOct 2012
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Leslie Morland, PsyD, Principal investigator, VA San Diego and University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110302
- Sponsor's protocol ID
- W81XWH-12- 1-0614
- Status last verified
- May 2019
- First submitted
- 30 Mar 2017
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khalifian CE, Glassman L, Mackintosh M, Grubbs K, Herbert M, Morland L. Improvement in mindful awareness during prolonged exposure treatment leads to reduction in posttraumatic stress disorder (PTSD) symptoms and anger expression. Psychol Trauma. 2026 Jun 18. doi: 10.1037/tra0002212. Online ahead of print.
PubMed 42313651Morland LA, Mackintosh MA, Glassman LH, Wells SY, Thorp SR, Rauch SAM, Cunningham PB, Tuerk PW, Grubbs KM, Golshan S, Sohn MJ, Acierno R. Home-based delivery of variable length prolonged exposure therapy: A comparison of clinical efficacy between service modalities. Depress Anxiety. 2020 Apr;37(4):346-355. doi: 10.1002/da.22979. Epub 2019 Dec 24.
PubMed 31872563
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Home Exposure Therapy for Veterans With Post Traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT03110302
- Acronym / sponsor ID
- W81XWH-12- 1-0614
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, Telehealth, Video teleconferencing, In home therapy, Prolonged Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Oct 2012 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 12 Apr 2017 (actual)
- 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.
This study examines clinical and process outcomes following variable length prolonged exposure (PE) for posttraumatic stress disorder (PTSD) delivered by one of three treatment modalities: home-based telehealth (HBT), office-based telehealth (OBT), or in-home-in-person (IHIP).
Detailed description
This study will provide a certain type of exposure therapy, called prolonged exposure therapy (PE), to military Veterans with Post Traumatic Stress Disorder (PTSD). One hundred and seventy-five Veterans will participate in the study. The main study goal is to compare PE conducted in three different ways: (1) PE that is office-based (OB; Veterans come to a VA clinic and meet with a therapist via telehealth, using videoconferencing technology), (2) PE delivered via home-based telehealth (HBT; Veterans stay at home and meet with the therapist via telehealth, using videoconferencing technology), and (3) PE delivered in home, in person (IHIP; the therapist goes to the Veterans' homes to provide the psychotherapy). Symptoms of PTSD, depression, and anxiety will be examined at pre-treatment, post-treatment and at six-month follow up to determine if symptoms change over time. Study hypotheses state that the IHIP approach, compared to the other two approaches, will be more effective at reducing the PTSD symptoms experienced by these Veterans because it will help Veterans attend each session and complete the therapy "homework" assigned by the therapists (such as doing feared, but safe, activities around the house or the neighborhood). However, the delivery of IHIP may cost more than the delivery of PE via the other modalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Office-based telehealth (OBT) | Active comparator | Behavioral: Prolonged exposureVeterans come to a VA clinic and meet with a therapist via telehealth, using videoconferencing technology |
| Home-based telehealth (HBT) | Active comparator | Behavioral: Prolonged exposureVeterans stay at home and meet with the therapist via telehealth, using videoconferencing technology |
| In home, in person (IHIP) | Experimental | Behavioral: Prolonged exposureTherapist goes to the Veterans' homes to provide the psychotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Military Veterans enrolled in a program at VASDHS;
- primary diagnosis of PTSD as a consequence of any index traumatic event. The diagnosis will include a clear memory of the traumatic event and the 17 other core symptoms of PTSD from the DSM-IV. Note that comorbid mood and anxiety disorders are expected and will be permitted (to maximize generalizability) if PTSD symptoms are judged to be predominant based on primacy and severity of symptoms. The proposed treatment often concurrently ameliorates depression and anxiety symptoms;
- age 18 or older; and
- Primary residence within 35 miles of the center point of La Jolla, CA center (to make therapist travel to home sites feasible for this project). This will include the major cities of San Diego, Chula Vista (23 miles Southeast; 30 minutes), La Mesa (19 miles East; 25 minutes), Coronado (18 miles South; 30 minutes), Oceanside (36 miles Southeast; 39 minutes), Escondido (27 miles northeast; 35 minutes) and San Ysidro (28 miles South; 32 minutes).
Key exclusion criteria (4 listed)
- unmanaged dementia, psychosis or manic episodes in past year (assessed by phone screen, chart review, and clinician judgment);
- substance or alcohol dependence in past 60 days (as assessed by the Alcohol Use Disorders Identification Test [AUDIT]);
- concurrent psychotherapies targeting PTSD (Veterans who are engaged in treatment for non PTSD symptoms, such as 12-step programs for substance problems or couples therapy for relationship issues, will remain eligible); and
- severe physical disease or disorder (e.g., cardiovascular or respiratory disease; severe impairments in speech, vision, or hearing) that would make it difficult to ensure regular attendance at psychotherapy sessions or would significantly impede learning (as assessed during phone screen discussion with potential participants). Potential participants who have had changes in the type and dosage of psychotropic medications in the preceding 60 days will be asked to wait until their medication regimen has stabilized to minimize treatment confounds. Psychotropic medication use will also be monitored to determine whether random assignment to treatment conditions resulted in unequal rates of use. As recommended by Bradley and colleagues, individuals with suicidal ideation will not be excluded from the study a priori, but rather suicidal urges or plans will be assessed throughout the study and appropriately addressed (by intervention or referral). The depression measure (the BDI-II) assesses suicidality explicitly (item 9). Dr. Thorp has extensive experience working with suicidal individuals and teaching crisis management skills, and the other study therapists will be trained in these skills as well.
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 exposureAlso: PEPE is a manualized treatment developed by Dr. Edna Foa and her colleagues. In all three treatment modalities, 7-15 weekly, 90 minute individual sessions of PE will be provided. PE is based on emotional processing theory, which proposes that avoidance and negative thoughts about the self and the world maintain PTSD symptoms over time. According to emotional processing theory, effective treatment requires repeated activation of the trauma memory (as through memory and in vivo exposure) and incorporation of corrective information into the trauma fear structure. PE has several primary components: (1) psychoeducation about PTSD and avoidance; (2) imaginal exposure with processing, wherein the participant describes the traumatic memory aloud many times and discusses it with the therapist afterward; and (3) in-vivo exposure, wherein the participant engages in feared, but safe, activities that have been avoided since the traumatic event (e.g., crowded places, driving). | Behavioural | Home-based telehealth (HBT), In home, in person (IHIP), Office-based telehealth (OBT) |
Primary outcome
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: From baseline to 9 months
The CAPS is a clinician-administered interview that assesses PTSD severity and diagnostic threshold. CAPS questions are designed to assess DSM-5 PTSD diagnostic criteria. CAPS has become the "gold standard" semistructured interview for assessing PTSD in the general population.
5 secondary outcomes
Change in Beck Depression Inventory (BDI-II)
Time frame: From baseline to 9 months
Change in PTSD Checklist (PCL-5)
Time frame: From baseline to 9 months
Change in Client Satisfaction Questionnaire (CSQ) - Short form
Time frame: From baseline to 3 months
Change in Therapist Satisfaction Questionnaire (TSQ)
Time frame: From baseline to 3 months
Change in Working Alliance Inventory - Short form (WAI-S)
Time frame: From baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Derived from this study: PubMed 42313651Khalifian CE, Glassman L, Mackintosh M, Grubbs K, Herbert M, Morland L. Improvement in mindful awareness during prolonged exposure treatment leads to reduction in posttraumatic stress disorder (PTSD) symptoms and anger expression. Psychol Trauma. 2026 Jun 18. doi: 10.1037/tra0002212. Online ahead of print.
- Derived from this study: PubMed 31872563Morland LA, Mackintosh MA, Glassman LH, Wells SY, Thorp SR, Rauch SAM, Cunningham PB, Tuerk PW, Grubbs KM, Golshan S, Sohn MJ, Acierno R. Home-based delivery of variable length prolonged exposure therapy: A comparison of clinical efficacy between service modalities. Depress Anxiety. 2020 Apr;37(4):346-355. doi: 10.1002/da.22979. Epub 2019 Dec 24.
- Individual participant dataSharing planned: No
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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.
Leslie Morland, PsyD principal investigator
VA San Diego and University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged exposure in people with Posttraumatic Stress Disorder, run by Veterans Medical Research Foundation 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 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: finished, as of the sponsor's last update on 14 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: From baseline to 9 months). 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 NCT03110302, which also lists 2 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 14 May 2019.