Post Traumatic Stress DisorderCOOPERATENCT06990191
A Hybrid 1 Effectiveness-Implementation Trial of Partner-Assisted Prolonged Exposure for PTSD
A study testing Partnered Prolonged Exposure (PPE) and Prolonged Exposure (PE) in people with Post Traumatic Stress Disorder, run by United States Department of Defense at 4 sites in United States.
Trial summary
PTSD occurs in up to 17% of post-9/11 US Service Members and is associated with long-term functional impairment, family problems, unemployment, and suicidality. Trauma-focused therapies (TFTs), such as Prolonged Exposure (PE), result in significant relief for many. Yet, TFTs are not equally effective for everyone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Partnered Prolonged Exposure (PPE) and Prolonged Exposure (PE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 May 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Post-9/11 Veteran Enrolled in VHA
- 1 > mo stable medication
- Committed relationship 6+ months
- DSM-5-R PTSD Diagnosis
Who cannot join
- Imminent suicidality/homicidally
- Mania, psychosis, or severe substance use disorder, past 3 mos
- Severe cognitive impairment
- Severe intimate partner violence in last 6 months
- Fear of or intimidation by partner
- Partner screens positive for PTSD
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Not yet recruiting
Charleston VA Healthcare System
Charleston, South Carolina, 29401
Sarah Szafranski, 843-543-0482, sarah.szafranski@va.gov
Ursula Myers, PhD
- Not yet recruiting
Minneapolis VA Healthcare System
Minneapolis, Minnesota, 55417
Emily M Hudson, PhD, 612-629-7262, emily.hudson@va.gov
Donald Lemon, 612-467-1957 ext. 311957, donald.lemon2@va.gov
- Not yet recruiting
Phoenix VA Healthcare System
Phoenix, Arizona, 85012
Donald Lemon, (612) 467-1957 ext. 311957, donald.lemon2@va.gov
Brandi Luedtke
- Recruiting
San Diego VA Healthcare System
San Diego, California, 92161
Alex Lin, (858) 552-8585 ext. 4325, alex.lin@va.gov
Alejandra Infante
About this study
PTSD occurs in up to 17% of post-9/11 US Service Members and is associated with long-term functional impairment, family problems, unemployment, and suicidality. Trauma-focused therapies (TFTs), such as Prolonged Exposure (PE), result in significant relief for many. Yet, TFTs are not equally effective for everyone. An important minority (~40%) will retain their PTSD diagnoses after treatment, and many discontinue treatment prematurely, especially post-9/11 Service Members. TFTs are also more effective in addressing symptoms than psychosocial functioning. More work is needed to improve the consistency and potency of TFTs. Partnering with significant others may provide a powerful method for helping individuals get more out of their PTSD treatment. Observational research shows that relationship factors can help patients initiate, stay in, and experience greater benefit from PTSD treatment. Veterans that were surveyed experienced greater treatment gains when they shared more about their treatment with loved ones and when loved ones accommodated less for PTSD symptoms. Despite the promise of partner-involved interventions, there is no couples approach to PTSD treatment that has demonstrated superior outcomes to individual-only treatment models (i.e., TFTs). To address this gap, the investigators have completed a series of partner-assisted PTSD treatment studies, leading up the current proposal (Partnered PE, PPE). The investigators found that treatment completion rates were better than routine clinical care, and the treatment led to large improvements in participants' functioning, PTSD symptoms, and romantic functioning. For this proposed study, the primary objective is to conduct a randomized controlled trial (Research Level 3; larger-scale clinical trial) to test the superiority of PPE to standard PE among post 9/11 Veterans. The investigator's primary hypothesis is that PPE will lead to greater improvements in psychosocial functioning than standard PE. Secondary and tertiary aims examine posttreatment clinical outcomes (PTSD, depression) and intimate partner outcomes (relationship functioning, distress, caregiver burden, and psychosocial functioning), as well as examine strategies for PPE implementation. In exploratory aims, the investigators will examine the stability of group differences, treatment completion rates, the role military sexual trauma history, and treatment mechanisms.
Read the detailed description
Background: PTSD occurs in up to 17% of post-9/11 US Service Members and is associated with long-term functional impairment, family problems, unemployment, and suicidality. Trauma-focused therapies (TFTs), such as Prolonged Exposure (PE), result in significant relief for many. Yet, TFTs are not equally effective for everyone. An important minority (~40%) will retain their PTSD diagnoses after treatment, and many discontinue treatment prematurely, especially post-9/11 Service Members. TFTs are also more effective in addressing symptoms than psychosocial functioning. More work is needed to improve the consistency and potency of TFTs. Partnering with significant others may provide a powerful method for helping individuals get more out of their PTSD treatment. Observational research shows that relationship factors can help patients initiate, stay in, and experience greater benefit from PTSD treatment. Veterans that were surveyed experienced greater treatment gains when they shared more about their treatment with loved ones and when loved ones accommodated less for PTSD symptoms. Despite the promise of partner-involved interventions, there is no couples approach to PTSD treatment that has demonstrated superior outcomes to individual-only treatment models (i.e., TFTs). To address this gap, the investigators have completed a series of partner-assisted PTSD treatment studies, leading up the current proposal (Partnered PE, PPE). In PPE, intimate partners attend weekly treatment sessions. The study uses strategies from Integrative Behavioral Couples Therapy (ICBT), an efficacious, acceptance-based martial therapy intervention, to help couples support each other during treatment. PPE strives to increase the potency of PE through (1) teaching partners to act as effective PE coaches at home and (2) helping couples discuss trauma-related concerns together, providing an additional laboratory for exposure-based learning. Pilot findings support the feasibility and effectiveness of PPE. Treatment completion rates were better than routine clinical care, and the treatment led to large improvements in participants' functioning, PTSD symptoms, and romantic functioning.
Objectives: Our primary objective is to conduct a randomized controlled trial (Research Level 3; larger-scale clinical trial) to test the superiority of PPE to standard PE among post 9/11 Veterans.
Aims: Our primary hypothesis is that PPE will lead to greater improvements in psychosocial functioning than standard PE. Secondary and tertiary aims examine posttreatment clinical outcomes (PTSD, depression) and intimate partner outcomes (relationship functioning, distress, caregiver burden, and psychosocial functioning), as well as examine strategies for PPE implementation. In exploratory aims, the investigators will examine the stability of group differences, treatment completion rates, the role of military sexual trauma history, and treatment mechanisms.
Study Design: The study will use a mixed-method two-group Hybrid Type I effectiveness implementation RCT to determine the superiority of PPE to PE. The study team will run the study across three VAs (San Diego, Charleston, and Phoenix) over four-years. The Minneapolis VA will serve as a back-up site. 210 individuals with PTSD and their intimate partners will be randomized to PPE or PE and assessed at baseline, mid-treatment, posttreatment, 3-, and 6-mos posttreatment. The study team will conduct qualitative interviews with study participants, therapists, and clinical administrators to assess barriers and facilitators to PPE implementation to guide future implementation work.
Clinical Impact: The influence of a successful course of PTSD treatment on an individual's life is considerable. However, among current and former Service Members, the most effective treatments for PTSD yield smaller effects and fewer individuals finish them. PPE is well poised to improve the potency of trauma-focused treatment to ensure PE promotes recovery from PTSD for more Service Members. The study team will also explore differences for those with a history of military sexual trauma. Additionally, partnering with significant others during PE can answer long-standing calls for family-centered PTSD care and extend the benefits of PTSD treatment to families. Family involvement in PTSD care is highly desired by Service Members, a fertile avenue for improving the outcomes for patients with PTSD, and a national priority. Such research is critical to military service retention and to the health of the entire military. If PPE is more effective than PE, this proposal could feed the growth of symptom-focused psychotherapies that largely exclude loved ones into systems-based interventions designed to lift the whole person within the context of their important relationships.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Partnered Prolonged Exposure (PPE), Prolonged Exposure (PE)
- Keywords
- Trauma-focused therapies, Prolonged exposure, Veterans, Integrative Behavioral Couples Therapy, couples, PTSD
- 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.
Partnered Prolonged Exposure (PPE)Behavioural
The PPE condition adapts the PE protocol with strategies from Integrative Behavioral Couples Therapy (an evidence-based couple therapy. PPE involves twice-weekly 60-minute sessions, with some sessions completed by both the Veteran and their partner while others are with the Veteran only.
Prolonged Exposure (PE)Behavioural
The PE condition will follow the standardized PE manual and involve weekly 90-minute sessions and a 30-minute check-in attended only by the Veteran and the therapist.
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Exposure (PE) | Active comparator | Not described Receives: Behavioral: Prolonged Exposure (PE) |
| Partnered Prolonged Exposure (PPE) | Experimental | Not described Receives: Behavioral: Partnered Prolonged Exposure (PPE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inventory of Psychosocial Functioning (IPF)
The primary outcome is Veterans' global functioning at posttreatment assessment. The subdimensions of global functioning that matter most to Veterans with PTSD are their relationships with intimate partners, family relationships, work performance, friend relationships, parenting, educational performance, and self-care functioning (e.g., maintaining personal hygiene, exercising, household chores, healthy eating). Outcomes will be measured using the Inventory of Psychosocial Functioning (IPF).
Measured: Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
Secondary outcomes (3)
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Gold standard, structured-clinical interview that assesses PTSD symptom severity.
Measured: Baseline, posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes. follow-up, 6 month follow-up
PTSD Checklist for DSM-5 (PCL-5)
Self-report instrument that measures PTSD symptom severity.
Measured: Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
Patient Health Questionnaire - 9 (PHQ-9)
Self-report instrument that measures depression severity
Measured: Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start16 May 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic 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
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Department of Defense
- Sponsor type
- US federal agency
- Collaborators
- University of Minnesota, Center for Veterans Research and Education, Arizona Veterans Research and Education Foundation, Lowcountry Center for Veterans Research, Veterans Medical Research Foundation, Minneapolis Veterans Affairs Medical Center, VA Palo Alto Health Care System, Atlanta VA Medical Center, Tampa VA Healthcare System, San Diego Veterans Healthcare System, Charleston VA Healthcare System, Phoenix VA Health Care System
- Responsible party
- Principal investigator, Laura A. Meis, University of Minnesota
- Investigators
- Laura Meis, PhD, Principal investigator, University of Minnesota, National Center for PTSD, Minneapolis VA Healthcare SystemLeslie Morland, PhD, Principal investigator, National Center for PTSD; San Diego VA Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990191
- Sponsor's protocol ID
- HT9425-24-1-0499
- Acronym
- COOPERATE
- Status last verified
- Sep 2026
- First submitted
- 29 Apr 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with 38 USC 7332, this type of information will be kept confidential and will not be disclosed in presentations, publications, or any other dissemination of the study results, or to anyone outside of the IRB-approved study team. Deidentified datasets will be made available following study completion. Participants will be notified of this during informed consent.
Publications
Cusack K, Jonas DE, Forneris CA, Wines C, Sonis J, Middleton JC, Feltner C, Brownley KA, Olmsted KR, Greenblatt A, Weil A, Gaynes BN. Psychological treatments for adults with posttraumatic stress disorder: A systematic review and meta-analysis. Clin Psychol Rev. 2016 Feb;43:128-41. doi: 10.1016/j.cpr.2015.10.003. Epub 2015 Nov 2.
PubMed 26574151Steenkamp MM, Litz BT, Hoge CW, Marmar CR. Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials. JAMA. 2015 Aug 4;314(5):489-500. doi: 10.1001/jama.2015.8370.
PubMed 26241600Bradley R, Greene J, Russ E, Dutra L, Westen D. A multidimensional meta-analysis of psychotherapy for PTSD. Am J Psychiatry. 2005 Feb;162(2):214-27. doi: 10.1176/appi.ajp.162.2.214.
PubMed 15677582Taft CT, Watkins LE, Stafford J, Street AE, Monson CM. Posttraumatic stress disorder and intimate relationship problems: a meta-analysis. J Consult Clin Psychol. 2011 Feb;79(1):22-33. doi: 10.1037/a0022196.
PubMed 21261431Jakupcak M, Cook J, Imel Z, Fontana A, Rosenheck R, McFall M. Posttraumatic stress disorder as a risk factor for suicidal ideation in Iraq and Afghanistan War veterans. J Trauma Stress. 2009 Aug;22(4):303-6. doi: 10.1002/jts.20423.
PubMed 19626682Kessler RC. Posttraumatic stress disorder: the burden to the individual and to society. J Clin Psychiatry. 2000;61 Suppl 5:4-12; discussion 13-4.
PubMed 10761674Richardson LK, Frueh BC, Acierno R. Prevalence estimates of combat-related post-traumatic stress disorder: critical review. Aust N Z J Psychiatry. 2010 Jan;44(1):4-19. doi: 10.3109/00048670903393597.
PubMed 20073563
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hybrid 1 Effectiveness-Implementation Trial of Partner-Assisted Prolonged Exposure for PTSD
- ClinicalTrials.gov ID
- NCT06990191
- Acronym / sponsor ID
- COOPERATE / HT9425-24-1-0499
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Trauma-focused therapies, Prolonged exposure, Veterans, Integrative Behavioral Couples Therapy, couples, PTSD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- United States Department of DefenseUS federal agency
- Collaborators
- University of Minnesota, Center for Veterans Research and Education, Arizona Veterans Research and Education Foundation, Lowcountry Center for Veterans Research, Veterans Medical Research Foundation, Minneapolis Veterans Affairs Medical Center, VA Palo Alto Health Care System, Atlanta VA Medical Center, Tampa VA Healthcare System, San Diego Veterans Healthcare System, Charleston VA Healthcare System, Phoenix VA Health Care System
- Study start
- 16 May 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 25 May 2025 (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.
PTSD occurs in up to 17% of post-9/11 US Service Members and is associated with long-term functional impairment, family problems, unemployment, and suicidality. Trauma-focused therapies (TFTs), such as Prolonged Exposure (PE), result in significant relief for many. Yet, TFTs are not equally effective for everyone. An important minority (~40%) will retain their PTSD diagnoses after treatment, and many discontinue treatment prematurely, especially post-9/11 Service Members. TFTs are also more effective in addressing symptoms than psychosocial functioning. More work is needed to improve the consistency and potency of TFTs. Partnering with significant others may provide a powerful method for helping individuals get more out of their PTSD treatment. Observational research shows that relationship factors can help patients initiate, stay in, and experience greater benefit from PTSD treatment. Veterans that were surveyed experienced greater treatment gains when they shared more about their treatment with loved ones and when loved ones accommodated less for PTSD symptoms. Despite the promise of partner-involved interventions, there is no couples approach to PTSD treatment that has demonstrated superior outcomes to individual-only treatment models (i.e., TFTs). To address this gap, the investigators have completed a series of partner-assisted PTSD treatment studies, leading up the current proposal (Partnered PE, PPE). The investigators found that treatment completion rates were better than routine clinical care, and the treatment led to large improvements in participants' functioning, PTSD symptoms, and romantic functioning. For this proposed study, the primary objective is to conduct a randomized controlled trial (Research Level 3; larger-scale clinical trial) to test the superiority of PPE to standard PE among post 9/11 Veterans. The investigator's primary hypothesis is that PPE will lead to greater improvements in psychosocial functioning than standard PE. Secondary and tertiary aims examine posttreatment clinical outcomes (PTSD, depression) and intimate partner outcomes (relationship functioning, distress, caregiver burden, and psychosocial functioning), as well as examine strategies for PPE implementation. In exploratory aims, the investigators will examine the stability of group differences, treatment completion rates, the role military sexual trauma history, and treatment mechanisms.
Detailed description
Background: PTSD occurs in up to 17% of post-9/11 US Service Members and is associated with long-term functional impairment, family problems, unemployment, and suicidality. Trauma-focused therapies (TFTs), such as Prolonged Exposure (PE), result in significant relief for many. Yet, TFTs are not equally effective for everyone. An important minority (~40%) will retain their PTSD diagnoses after treatment, and many discontinue treatment prematurely, especially post-9/11 Service Members. TFTs are also more effective in addressing symptoms than psychosocial functioning. More work is needed to improve the consistency and potency of TFTs. Partnering with significant others may provide a powerful method for helping individuals get more out of their PTSD treatment. Observational research shows that relationship factors can help patients initiate, stay in, and experience greater benefit from PTSD treatment. Veterans that were surveyed experienced greater treatment gains when they shared more about their treatment with loved ones and when loved ones accommodated less for PTSD symptoms. Despite the promise of partner-involved interventions, there is no couples approach to PTSD treatment that has demonstrated superior outcomes to individual-only treatment models (i.e., TFTs). To address this gap, the investigators have completed a series of partner-assisted PTSD treatment studies, leading up the current proposal (Partnered PE, PPE). In PPE, intimate partners attend weekly treatment sessions. The study uses strategies from Integrative Behavioral Couples Therapy (ICBT), an efficacious, acceptance-based martial therapy intervention, to help couples support each other during treatment. PPE strives to increase the potency of PE through (1) teaching partners to act as effective PE coaches at home and (2) helping couples discuss trauma-related concerns together, providing an additional laboratory for exposure-based learning. Pilot findings support the feasibility and effectiveness of PPE. Treatment completion rates were better than routine clinical care, and the treatment led to large improvements in participants' functioning, PTSD symptoms, and romantic functioning.
Objectives: Our primary objective is to conduct a randomized controlled trial (Research Level 3; larger-scale clinical trial) to test the superiority of PPE to standard PE among post 9/11 Veterans.
Aims: Our primary hypothesis is that PPE will lead to greater improvements in psychosocial functioning than standard PE. Secondary and tertiary aims examine posttreatment clinical outcomes (PTSD, depression) and intimate partner outcomes (relationship functioning, distress, caregiver burden, and psychosocial functioning), as well as examine strategies for PPE implementation. In exploratory aims, the investigators will examine the stability of group differences, treatment completion rates, the role of military sexual trauma history, and treatment mechanisms.
Study Design: The study will use a mixed-method two-group Hybrid Type I effectiveness implementation RCT to determine the superiority of PPE to PE. The study team will run the study across three VAs (San Diego, Charleston, and Phoenix) over four-years. The Minneapolis VA will serve as a back-up site. 210 individuals with PTSD and their intimate partners will be randomized to PPE or PE and assessed at baseline, mid-treatment, posttreatment, 3-, and 6-mos posttreatment. The study team will conduct qualitative interviews with study participants, therapists, and clinical administrators to assess barriers and facilitators to PPE implementation to guide future implementation work.
Clinical Impact: The influence of a successful course of PTSD treatment on an individual's life is considerable. However, among current and former Service Members, the most effective treatments for PTSD yield smaller effects and fewer individuals finish them. PPE is well poised to improve the potency of trauma-focused treatment to ensure PE promotes recovery from PTSD for more Service Members. The study team will also explore differences for those with a history of military sexual trauma. Additionally, partnering with significant others during PE can answer long-standing calls for family-centered PTSD care and extend the benefits of PTSD treatment to families. Family involvement in PTSD care is highly desired by Service Members, a fertile avenue for improving the outcomes for patients with PTSD, and a national priority. Such research is critical to military service retention and to the health of the entire military. If PPE is more effective than PE, this proposal could feed the growth of symptom-focused psychotherapies that largely exclude loved ones into systems-based interventions designed to lift the whole person within the context of their important relationships.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure (PE) | Active comparator | Behavioral: Prolonged Exposure (PE) |
| Partnered Prolonged Exposure (PPE) | Experimental | Behavioral: Partnered Prolonged Exposure (PPE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Post-9/11 Veteran Enrolled in VHA
- 1 > mo stable medication
- Committed relationship 6+ months
- DSM-5-R PTSD Diagnosis
Key exclusion criteria (6 listed)
- Imminent suicidality/homicidally
- Mania, psychosis, or severe substance use disorder, past 3 mos
- Severe cognitive impairment
- Severe intimate partner violence in last 6 months
- Fear of or intimidation by partner
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 |
|---|---|---|
| Partnered Prolonged Exposure (PPE)The PPE condition adapts the PE protocol with strategies from Integrative Behavioral Couples Therapy (an evidence-based couple therapy. PPE involves twice-weekly 60-minute sessions, with some sessions completed by both the Veteran and their partner while others are with the Veteran only. | Behavioural | Partnered Prolonged Exposure (PPE) |
| Prolonged Exposure (PE)The PE condition will follow the standardized PE manual and involve weekly 90-minute sessions and a 30-minute check-in attended only by the Veteran and the therapist. | Behavioural | Prolonged Exposure (PE) |
Primary outcome
Inventory of Psychosocial Functioning (IPF)
Time frame: Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
The primary outcome is Veterans' global functioning at posttreatment assessment. The subdimensions of global functioning that matter most to Veterans with PTSD are their relationships with intimate partners, family relationships, work performance, friend relationships, parenting, educational performance, and self-care functioning (e.g., maintaining personal hygiene, exercising, household chores, healthy eating). Outcomes will be measured using the Inventory of Psychosocial Functioning (IPF).
3 secondary outcomes
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: Baseline, posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes. follow-up, 6 month follow-up
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
Patient Health Questionnaire - 9 (PHQ-9)
Time frame: Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 26574151Cusack K, Jonas DE, Forneris CA, Wines C, Sonis J, Middleton JC, Feltner C, Brownley KA, Olmsted KR, Greenblatt A, Weil A, Gaynes BN. Psychological treatments for adults with posttraumatic stress disorder: A systematic review and meta-analysis. Clin Psychol Rev. 2016 Feb;43:128-41. doi: 10.1016/j.cpr.2015.10.003. Epub 2015 Nov 2.
- Background: PubMed 26241600Steenkamp MM, Litz BT, Hoge CW, Marmar CR. Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials. JAMA. 2015 Aug 4;314(5):489-500. doi: 10.1001/jama.2015.8370.
- Background: PubMed 15677582Bradley R, Greene J, Russ E, Dutra L, Westen D. A multidimensional meta-analysis of psychotherapy for PTSD. Am J Psychiatry. 2005 Feb;162(2):214-27. doi: 10.1176/appi.ajp.162.2.214.
- Background: PubMed 21261431Taft CT, Watkins LE, Stafford J, Street AE, Monson CM. Posttraumatic stress disorder and intimate relationship problems: a meta-analysis. J Consult Clin Psychol. 2011 Feb;79(1):22-33. doi: 10.1037/a0022196.
- Background: PubMed 19626682Jakupcak M, Cook J, Imel Z, Fontana A, Rosenheck R, McFall M. Posttraumatic stress disorder as a risk factor for suicidal ideation in Iraq and Afghanistan War veterans. J Trauma Stress. 2009 Aug;22(4):303-6. doi: 10.1002/jts.20423.
- Background: PubMed 10761674Kessler RC. Posttraumatic stress disorder: the burden to the individual and to society. J Clin Psychiatry. 2000;61 Suppl 5:4-12; discussion 13-4.
- Background: PubMed 20073563Richardson LK, Frueh BC, Acierno R. Prevalence estimates of combat-related post-traumatic stress disorder: critical review. Aust N Z J Psychiatry. 2010 Jan;44(1):4-19. doi: 10.3109/00048670903393597.
- Individual participant dataSharing planned: Yes. In accordance with 38 USC 7332, this type of information will be kept confidential and will not be disclosed in presentations, publications, or any other dissemination of the study results, or to anyone outside of the IRB-approved study team. Deidentified datasets will be made available following study completion. Participants will be notified of this during informed consent.
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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.
Laura Meis, PhD principal investigator
University of Minnesota, National Center for PTSD, Minneapolis VA Healthcare System
Leslie Morland, PhD principal investigator
National Center for PTSD; San Diego VA Healthcare System
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partnered Prolonged Exposure (PPE) and Prolonged Exposure (PE) in people with Post Traumatic Stress Disorder, run by United States Department of Defense at 4 sites 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 6 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily M Hudson, PhD (612-629-7262, emily.hudson@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inventory of Psychosocial Functioning (IPF) (time frame: Baseline, mid-treatment (between session 5-6), posttreatment (immediately after treatment closes), and 3-months and 6-months after treatment closes.). 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 NCT06990191, which also lists 7 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 11 Sep 2026.