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

NCT07756723 | Recruiting Phase 2

• 1 other identifier: 1882489
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder (PTSD); Substance Use Disorder (SUD)

Keywords

PTSD; SUD; Veterans; HRV; Biofeedback

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• PTSD Symptom Checklist for the DSM-5 (PCL-5)

  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 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).

  Assessed at the pre and post treatment visits, with the primary outcome being the baseline measures of the variable.

Study Arms (2)

Trauma Informed Heart Rate Variability Biofeedback (T-HRVB)

EXPERIMENTAL

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

Present Centered Therapy (PCT)

ACTIVE COMPARATOR

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

Interventions

Trauma Informed Heart Rate Variability Biofeedback BEHAVIORAL

please see description in the arm of the study for details.

Trauma Informed Heart Rate Variability Biofeedback (T-HRVB)

Present Centered Therapy BEHAVIORAL

please see description in the arm of the study for details.

Present Centered Therapy (PCT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PTSD diagnosis
• Enrolled in VA healthcare
• Attending residential programming at CVAMC
• Current substance use difficulty based on screening questions

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coatesville VA Medical Center: lead

Study Sites (1)

Coatesville VA Medical Center

Coatesville, Pennsylvania, 19320, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Central Study Contacts

Alexander A Puhalla, Ph.D.

CONTACT

610-384-7711; alexander.puhalla@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychologist / Coordinator

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 11, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)