A Hybrid 1 Effectiveness-Implementation Trial of Partner-Assisted Prolonged Exposure for PTSD

NCT ID: NCT06990191

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-16
• Study Completion Date: 2028-08-31

Brief 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. 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.

Conditions

Post Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Prolonged Exposure (PE)

Group Type: ACTIVE_COMPARATOR

Prolonged Exposure (PE)

Intervention Type: BEHAVIORAL

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.

Partnered Prolonged Exposure (PPE)

Group Type: EXPERIMENTAL

Partnered Prolonged Exposure (PPE)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Post-9/11 Veteran Enrolled in VHA
• 1 > mo stable medication
• Committed relationship 6+ months
• DSM-5-R PTSD Diagnosis

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: lead

University of Minnesota

OTHER

Sponsor Role: collaborator

Center for Veterans Research and Education

OTHER

Sponsor Role: collaborator

Arizona Veterans Research and Education Foundation

UNKNOWN

Sponsor Role: collaborator

Lowcountry Center for Veterans Research

UNKNOWN

Sponsor Role: collaborator

Veterans Medical Research Foundation

OTHER

Sponsor Role: collaborator

Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role: collaborator

VA Palo Alto Health Care System

FED

Sponsor Role: collaborator

Atlanta VA Medical Center

FED

Sponsor Role: collaborator

Tampa VA Healthcare System

UNKNOWN

Sponsor Role: collaborator

San Diego Veterans Healthcare System

FED

Sponsor Role: collaborator

Charleston VA Healthcare System

UNKNOWN

Sponsor Role: collaborator

Phoenix VA Health Care System

FED

Sponsor Role: collaborator

Responsible Party

Laura A. Meis

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Meis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota, National Center for PTSD, Minneapolis VA Healthcare System

Leslie Morland, PhD

Role: PRINCIPAL_INVESTIGATOR

National Center for PTSD; San Diego VA Healthcare System

Locations

Phoenix VA Healthcare System

Phoenix, Arizona, United States

Site Status: NOT_YET_RECRUITING

San Diego VA Healthcare System

San Diego, California, United States

Site Status: RECRUITING

Minneapolis VA Healthcare System

Minneapolis, Minnesota, United States

Site Status: NOT_YET_RECRUITING

Charleston VA Healthcare System

Charleston, South Carolina, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Emily M Hudson, PhD

Role: CONTACT

emily.hudson@va.gov

612-629-7262

Donald Lemon

Role: CONTACT

donald.lemon2@va.gov

(612) 467-1957 ext. 311957

Facility Contacts

Donald Lemon

Role: primary

donald.lemon2@va.gov

(612) 467-1957 ext. 311957

Alex Lin

Role: primary

alex.lin@va.gov

(858) 552-8585 ext. 4325

Emily M Hudson, PhD

Role: primary

emily.hudson@va.gov

612-629-7262

Donald Lemon

Role: backup

donald.lemon2@va.gov

612-467-1957 ext. 311957

Sarah Szafranski

Role: primary

sarah.szafranski@va.gov

843-543-0482

References

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Reference Type: BACKGROUND

PMID: 26574151 (View on PubMed)

Steenkamp 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.

Reference Type: BACKGROUND

PMID: 26241600 (View on PubMed)

Bradley 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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 21261431 (View on PubMed)

Jakupcak 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.

Reference Type: BACKGROUND

PMID: 19626682 (View on PubMed)

Kessler RC. Posttraumatic stress disorder: the burden to the individual and to society. J Clin Psychiatry. 2000;61 Suppl 5:4-12; discussion 13-4.

Reference Type: BACKGROUND

PMID: 10761674 (View on PubMed)

Richardson 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.

Reference Type: BACKGROUND

PMID: 20073563 (View on PubMed)

Other Identifiers

HT9425-24-1-0499

Identifier Type: -

Identifier Source: org_study_id