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NCT Number: NCT07756723

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Coatesville VA Medical Center

Coatesville, Pennsylvania, 19320, United States

Location status: Recruiting

Location contact

Alexander A Puhalla, Ph.D.

CONTACT

[email protected]

610-384-7711 ext. x2848

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trauma Informed Heart Rate Variability Biofeedback

Behavioral

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

Present Centered Therapy

Behavioral

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

Primary outcomes

  1. Clinician Administered PTSD Scale for DSM-5 Revised

    Time frame: 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.

    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.

  2. Heart Rate (HR)

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

    Heart Rate will be utilized as the study's primary measure of overall autonomic arousal.

  3. Respiratory Sinus Arrythmia

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

    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.

  4. Skin Conductance Level

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

    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.

Secondary outcomes

  1. PTSD Symptom Checklist for the DSM-5 (PCL-5)

    Time frame: 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.

    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

  2. Root Mean Square of Successive Differences (Rmssd)

    Time frame: Rmssd will be assessed at the pre and post treatment visits, with the baseline measure being a primary outcome at both timepoints.

    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.

  3. Standard Deviation between Normal to Nrmal intervals (SDNN).

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander A Puhalla, Ph.D.

CONTACT

[email protected]

610-384-7711 ext. x2848

Sponsors and collaborators

Lead sponsor

Coatesville VA Medical Center

Unknown

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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