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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

First listed

Aug 11, 2026

Start date

Aug 31, 2026

Status verified

Aug 2026

Primary completion

Aug 31, 2029

Completion

Aug 31, 2030

Study Design

Enrollment

50 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.

Primary Outcome Measure

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. ]

Central Contacts

• Alexander A Puhalla, Ph.D.
  610-384-7711
  [email protected]

Locations (1)

Find similar trials in Coatesville, PA

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