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The Many Roads to Trauma Recovery: A Clinical Trial Comparing Empirically Supported Treatments for Veterans With Co-Morbid Posttraumatic Stress and Substance Use Disorder Symptoms
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * PTSD diagnosis * Enrolled in VA healthcare * Attending residential programming at CVAMC * Current substance use difficulty based on screening questions Exclusion Criteria: * Non-English speaking * Inability to complete study procedures * Lack competency to provide consent * Acute intoxication of a substance * Active psychotic symptoms at the study visit * Suicidal or homicidal ideation with intent and planning * Pacemaker or other cardiovascular implants.
About the study
Veterans with co-morbid posttraumatic stress disorder (PTSD) and substance use disorders (SUDs) are at substantial risk of developing hypertension and cardiovascular diseases that often lead to premature death, with some evidence that they may die over 10 years earlier than their counterparts. As such, determining ways to improve their health outcomes is vital. Heart Rate Variability Biofeedback (HRVB) may be one way to restore autonomic balance and teach veterans with PTSD / SUDs how to respond differently to their symptoms. Multiple studies have found that HRVB not only improves autonomic nervous system (ANS) regulation / flexibility among veterans with PTSD, but also reduces PTSD symptoms. Additionally, there is evidence that HRVB reduces cravings and SUD symptoms. Currently it is proposed that the improvement in the PTSD and SUD symptoms are due to a combination of improving ANS regulation and veterans utilizing the HRVB techniques as coping strategies for their symptoms. Yet, none of these studies examined how HRVB versus other active interventions differentially effected symptoms and physiological outcomes. It may be useful to examine HRVB to other active interventions . The current project proposes to alleviate this gap by examining the effects of HRVB to one a active control condition (i.e., Present Centered Psychotherapy; PCT) among 50-residential veterans engaging in PTSD residential programming. Veterans will be recruited from residential programs at the Coatesville VAMC and screened for probable PTSD and an active (i.e., past year) SUD. If eligible, they will attend a brief visit that will include being randomized, engaging in a diagnostic interview, a battery of questionnaires related to PTSD / SUDs, attached to physiology equipment, and then complete 3 tasks (i.e., baseline task, emotion induction, and HRVB or Self-Compassion Break). Upon task completion, all veterans will be screened for risk and begin one of the conditions. Similar research procedures will be conducted after their final session. This study would provide evidence for the real-world effectiveness of HRVB compared to a control condition among one of the highest risk populations treated at the VA, which may provide invaluable insight into active mind-body treatments for veterans with PTSD / SUD.
What is being tested
- Trauma Informed Heart Rate Variability Biofeedback (behavioral)
- Present Centered Therapy (behavioral)
Sponsor: Coatesville VA Medical Center · Participants: 50 · Started: 2026-08
Contact the study team
- Alexander A Puhalla, Ph.D. · Phone: 610-384-7711
Official record on ClinicalTrials.gov — NCT07756723
Locations in the U.S.
| Pennsylvania | Coatesville VA Medical Center, Coatesville |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.