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

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.

Study Overview

• Status: Recruiting
• Conditions: Posttraumatic Stress Disorder (PTSD); Substance Use Disorder (SUD)
• Intervention / Treatment: Behavioral: Trauma Informed Heart Rate Variability Biofeedback; Behavioral: Present Centered Therapy

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Alexander A Puhalla, Ph.D.; Phone Number: x2848 610-384-7711; Email: alexander.puhalla@va.gov

Study Locations

• United States
  • Pennsylvania
    • Coatesville, Pennsylvania, United States, 19320
      • Recruiting
      • Coatesville VA Medical Center
      • Contact: Alexander A Puhalla, Ph.D.; Phone Number: x2848 610-384-7711; Email: alexander.puhalla@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trauma Informed Heart Rate Variability Biofeedback (T-HRVB); HRVB is a specific intervention that increases HRV by finding the optimal breathing frequency that will synchronize with HR oscillations (i.e., between 4 to 7 breaths per minute), increase the amount and intensity of HR variation while engaging in the biofeedback, and overtime improve HRV and overall functioning by activating both the vagus nerve and baroreceptor during practice. T-HRVB is a six session flexible protocol that integrates active trauma informed psychotherapy into HRVB, as well as scaffolds breathing skills based on the needs of population and encourages the use of these skills as active coping skills (Puhalla et al., 2026). Additionally, active psychotherapy skills are utilized throughout to bolster a sense of agency and engagement with the techniques.	Behavioral: Trauma Informed Heart Rate Variability Biofeedback; please see description in the arm of the study for details.
Active Comparator: Present Centered Therapy (PCT); The PCT condition will be the study's control condition where veterans will engage in six sessions. While PCT has shown some effect on improving PTSD symptoms, , it is generally a non-specific therapeutic modality where the therapist provides support and validation for the patient and encouragement towards their goal of stress reduction. In accordance with the study, six sessions will be provided with the psychoeducation on PTSD and the homework sheet being provided in session one since an intake has already occurred with their non-research provider.	Behavioral: Present Centered Therapy; please see description in the arm of the study for details.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Administered PTSD Scale for DSM-5 Revised	The CAPS-5-R is the newest version of the CAPS-5, which is a structured diagnostic interview for PTSD based on the PTSD criteria in the DSM-5. All 20 symptoms of PTSD are assessed in relation to a patient's index event, which is then rated on a zero to ten severity scale with qualitative and quantitative indicators for each level of severity. Throughout the assessment symptoms that are less trauma specific include a prompt to determine if the symptom is related to the index event. The CAPS-5-R will be the studies primary outcome variable for PTSD symptom severity.	The CAPS-5-R is conducted at the pre and post treatment visit, which typically will occur during the 1st week of treatment and the last. However, due to scheduling needs may occur a prior (pre) or following (post) week.
Heart Rate (HR)	Heart Rate will be utilized as the study's primary measure of overall autonomic arousal.	Assessed at the pre and post treatment visits, with the primary outcome being the baseline measures of the variable.
Respiratory Sinus Arrythmia	To determine parasympathetic activity, the R-spike to R-spike interval will go through a Fourier transformation and the amount of power that occurs in the high frequency range (0.15-0.04 Hz) will be used as our measure of vagal mediated parasympathetic activity, also known as RSA.	Assessed at the pre and post treatment visits, with the primary outcome being the baseline measures of the variable.
Skin Conductance Level	Resting Skin Conductance Level may be used as proxy of sympathetic activity at rest, which is collected through a skin conductance monitor on the participants palm / fingers.	Assessed at the pre and post treatment visits, with the primary outcome being the baseline measures of the variable.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Symptom Checklist for the DSM-5 (PCL-5)	The PCL-5 is 20-item self-report questionnaire that assesses each symptom of PTSD on a 5-point Likert Scale. The PCL-5 will be used to assess for PTSD symptom severity	Provided at the pre and post treatment visit, which typically will occur during the 1st week of treatment and the last. However, due to scheduling needs may occur a prior (pre) or following (post) week.
Root Mean Square of Successive Differences (Rmssd)	Rmssd is a time-domain measure of vagal mediated parasympathetic activity that is determined by calculating the root mean square of successive differences within a heart beat to heart beat interval (R to R interval). It is commonly used as a proxy for parasmypathetic activity or regulation.	Rmssd will be assessed at the pre and post treatment visits, with the baseline measure being a primary outcome at both timepoints.
Standard Deviation between Normal to Nrmal intervals (SDNN).	SDNN is a time domain HRV measure that acts as a proxy for overall autonomic nervous system activity and health, with greater levels usually indicative of greater health.	Assessed at the pre and post treatment visits, with the primary outcome being the baseline measures of the variable.

Collaborators and Investigators

• Sponsor: Coatesville VA Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: August 7, 2026
• First Submitted That Met QC Criteria: August 7, 2026
• First Posted (Actual): August 11, 2026

Study Record Updates

• Last Update Posted (Actual): August 11, 2026
• Last Update Submitted That Met QC Criteria: August 7, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; Veterans; Biofeedback; HRV; SUD
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders; Stress Disorders, Traumatic; Substance-Related Disorders; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 1882489

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Directly states within the consent form that the data would not be shared outside of the research team due to the high sensitivity of the data being collected.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No