An interventional study of Family Supported Prolonged Exposure and Standard Prolonged Exposure in Posttraumatic Stress Disorder, sponsored by VA Office of Research and Development. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-14.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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Among 263 studies in Stress Disorders, Post-Traumatic by VA Office of Research and Development — 56 open to participants now, 65 under way, 4 of them phase 3. Stress Disorders, Post-Traumatic · VA Office of Research and Development.
Among the 263 studies in Stress Disorders, Post-Traumatic by VA Office of Research and Development, this one is the 82nd largest by enrollment of the 246 interventional ones that give a count, is one of 17 that started in 2018, is one of 185 with no phase, and was the 113th registered.
2,683 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
Browse Stress Disorders, Post-Traumatic studies →56 of the 263 studies in Stress Disorders, Post-Traumatic by VA Office of Research and Development are open now, in 1 country. Recruiting first, the newest first:
VA Office of Research and Development · Sites in United States
Ages 22–70
VA Office of Research and Development · Sites in United States
Ages 18+
VA Office of Research and Development · Sites in United States
Ages 18–75
VA Office of Research and Development · Sites in United States
Ages 18–75
VA Office of Research and Development · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 416 Stress Disorders, Post-Traumatic studies recruiting now, 186 (45%) set no upper age limit and 204 (49%) stop at 75 or younger; 63 take children under 18; 89 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
263 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 30 · Phase 3 10 · Phase 4 14
First in 2000; this study’s year is marked. 17 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 128 is above the median of 69 across 2,197 interventional studies indexed under Stress Disorders, Post-Traumatic.
Median enrollment 87 across the 246 interventional studies, 110 across the 17 observational. Of the 194 that completed or were terminated, 167 (86%) have results posted.
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VA Office of Research and Development is the lead sponsor of 1,773 studies on the registry; 393 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
22 of the studies in Stress Disorders, Post-Traumatic by VA Office of Research and Development that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06000475VA Office of Research and DevelopmentEnhancing Memory in Cognitive Processing Therapy for PTSD | 2026-12-31 |
| NCT05812131VA Office of Research and DevelopmentCOPEWeb Training for Providers | 2027-01-01 |
| NCT05149534VA Office of Research and DevelopmentrTMS-augmented Written Exposure Therapy for PTSD | 2027-01-29 |
| NCT05776056VA Office of Research and DevelopmentMethylphenidate for the Treatment of PTSD With Associated Neurocognitive Complaints | 2027-03-31 |
| NCT05789329VA Office of Research and DevelopmentNon-Inferiority Trial of TrIGR for PTSD | 2027-03-31 |
Add all 22 to your calendar (.ics) → With an account.
Among the 263 studies in Stress Disorders, Post-Traumatic by VA Office of Research and Development, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Evidence-based psychotherapies (EBP) for PTSD, such as Prolonged Exposure (PE), result in clinically significant symptom relief for many. Yet, adherence to this treatment (i.e., session attendance and homework compliance), which is vital to ensuring recovery, can be poor. This project will test the effectiveness of improving family support for PE as a tool to improve Veterans' PE adherence. Reducing rates of dropout from PE will positively impact Veterans' health and well-being and lower the cost of treating PTSD. Additionally, despite congressional legislation and national mandates within VA/DoD for family involvement in PTSD care, there remains no proven strategies for how to routinely include family in traditional individual (i.e., one-on-one) EBPs for PTSD. This proposal will provide the initial test of a model of family engagement that can be translated to other problems faced by Veterans, including suicide prevention, traumatic brain injury (TBI) rehabilitation, and pain management, contributing to a broader evolution towards evidence-based, family-inclusive care.
Impacts. This study aims to improve Veterans' adherence to evidence-based treatment for PTSD, through increasing family support for treatment. Improving retention rates in evidence-based PTSD treatment will positively impact Veterans' health and well-being, lower the cost of treating PTSD, and decrease long-term demand for PTSD services. If effective, this approach could help resolve national calls for routine inclusion of family involvement in PTSD treatment. Once demonstrated for PTSD, these strategies could be utilized for other conditions and problems relevant to Veteran populations (e.g., suicide prevention, traumatic brain injury (TBI) rehabilitation) and stimulate shifts across practice and policy to better routine and evidence-based involvement of families in care.
Background. PTSD occurs in as many as 1 in 5 combat Veterans and is associated with a host of negative, long-term consequences to the individual, their families, and society at large. Evidence-based psychotherapies, such as Prolonged Exposure (PE), result in clinically significant symptom relief for many. Yet, adherence to these treatments (i.e., session attendance and homework compliance), which is vital to ensuring recovery, can be poor. Engaging families in Veterans' treatment may provide a powerful method for promoting EBP adherence. The investigators data indicate that 70% of Veterans express some interest in involving their family in their care for PTSD; yet, only 17% of providers have had any contact with Veterans' families. The objective of the proposed study is to evaluate the effectiveness of improving family support as a tool to improve Veterans' EBP adherence. This research agenda directly addresses two VA HSR\&D priorities:
Objectives/Aims. Aim 1: To improve Veterans' adherence to PE through engaging families in care.
H1: Veterans randomized to family supported PE will attend more sessions (H1a) and report greater homework compliance (H1b) than Veterans randomized to standard PE delivered in routine care.
Aim 2: To improve the clinical outcomes of Veterans receiving PE through engaging families in care.
H2: Family supported PE will be more effective than standard PE in reducing PTSD severity and comorbid problems (depression, quality of life, relationship functioning) from baseline to posttreatment.
Aim 3: To examine barriers/facilitators of implementing family support for PE. Exploratory Aim: To identify mechanisms underlying adherence differences between treatment conditions.
The investigators will explore if adherence differences are mediated by changes on key social influence variables (family perceptions of treatment credibility, family support for PE, and family symptom accommodation).
Methods. The investigators are proposing a practical randomized controlled trial to compare Veteran adherence, and to PE with and without family attendance at PE's educational sessions, with the ultimate goal to improve Veterans' clinical outcomes. For Aim 3, the investigators will use a concurrent process evaluation to identify potential implementation facilitators and barriers to family involvement in PE within VA. Participants will include Veterans with clinically significant symptoms of PTSD across three sites, plus a family member or friend of the Veteran. Aim 1 outcome variables include session attendance and homework compliance. Aim 2 outcomes include PTSD symptom severity, depression, quality of life, and relationship functioning, measured monthly over the course of treatment. Key social influences (Exploratory Aim) will be assessed through brief weekly self-reports.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.
Behavioral: Family Supported Prolonged Exposure
Standard Prolonged Exposure for PTSD as delivered in routine VA care.
Behavioral: Standard Prolonged Exposure
The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.
Standard Prolonged Exposure for PTSD as delivered in routine VA care.
Session Attendance
Number of treatment sessions attended by the participant
Time frame: 16 weeks
PTSD Checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Range of scale is 0-80 and can be obtained by summing the scores for each of the 20 items. Higher scores indicate higher PTSD symptom levels.
Time frame: 16 weeks
| Milestone | Family Supported Prolonged Exposure | Standard Prolonged Exposure |
|---|---|---|
| Started | 64 | 64 |
| Completed | 36 | 25 |
| Not completed | 28 | 39 |
Number of treatment sessions attended by the participant
| sessions | Family Supported Prolonged Exposure | Standard Prolonged Exposure |
|---|---|---|
| Session Attendance | 6.77 ± 3.99 | 5.56 ± 4.16 |
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Range of scale is 0-80 and can be obtained by summing the scores for each of the 20 items. Higher scores indicate higher PTSD symptom levels.
| score on a scale | Family Supported Prolonged Exposure | Standard Prolonged Exposure |
|---|---|---|
| PTSD Checklist for DSM-5 (PCL-5) | 51.56 ± 12.60 | 53.79 ± 12.54 |
Collected over Treatment initiation through 3 month follow-up, up to 40 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Family Supported Prolonged Exposure | 0/64 (0%) | 2/64 (3.1%) | 17/64 (26.6%) |
| Standard Prolonged Exposure | 0/64 (0%) | 2/64 (3.1%) | 20/64 (31.3%) |
| Event | Family Supported Prolonged Exposure | Standard Prolonged Exposure |
|---|---|---|
| Severe Suicidal ideationPsychiatric disorders | 2/64 | 1/64 |
| Psychological decompisationPsychiatric disorders | 0/64 | 1/64 |
| Event | Family Supported Prolonged Exposure | Standard Prolonged Exposure |
|---|---|---|
| ER visitGeneral disorders | 11/64 | 14/64 |
| HospitalizationGeneral disorders | 8/64 | 6/64 |
| Mild Suicidal ideationPsychiatric disorders | 0/64 | 2/64 |
Includes baseline data for all Veteran participants in the study
| Age, Continuous(years) | Family Supported Prolonged Exposure | Standard Prolonged Exposure | Total |
|---|---|---|---|
| Mean | 49.30 ± 14.70 | 51.23 ± 15.04 | 50.38 ± 14.81 |
| Sex: Female, Male(Participants) | Family Supported Prolonged Exposure | Standard Prolonged Exposure | Total |
|---|---|---|---|
| Female | 14 | 11 | 25 |
| Male | 50 | 53 | 103 |
| Race/Ethnicity, Customized(Participants) | Family Supported Prolonged Exposure | Standard Prolonged Exposure | Total |
|---|---|---|---|
| Race/Ethnicity — Black | 14 | 14 | 28 |
| Race/Ethnicity — Hispanic/Latino | 1 | 4 | 5 |
| Race/Ethnicity — White | 41 | 36 | 77 |
| Race/Ethnicity — Multiracial | 4 | 6 | 10 |
| Race/Ethnicity — Unknown | 4 | 4 | 8 |
| Lives with Significant Other(Participants) | Family Supported Prolonged Exposure | Standard Prolonged Exposure | Total |
|---|---|---|---|
| Count of participants | 48 | 40 | 88 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Jun 2022, 53 months.
Results were first posted in Jun 2024, 1 year 11 months after primary completion.
Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 53 months is above that.
Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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