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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

7. srpna 2026 aktualizováno: Alexander Puhalla, Coatesville VA Medical Center
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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

50

Fáze

  • Fáze 2
  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Spojené státy
    • Pennsylvania
      • Coatesville, Pennsylvania, Spojené státy, 19320
        • Nábor
        • Coatesville VA Medical Center
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: Trauma Informed Heart Rate Variability Biofeedback
please see description in the arm of the study for details.
Aktivní komparátor: 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.
Behaviorální: Present Centered Therapy
please see description in the arm of the study for details.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Clinician Administered PTSD Scale for DSM-5 Revised
Časové okno: 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.
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)
Časové okno: 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.
Assessed at the pre and post treatment visits, with the primary outcome being the baseline measures of the variable.
Respiratory Sinus Arrythmia
Časové okno: 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.
Assessed at the pre and post treatment visits, with the primary outcome being the baseline measures of the variable.
Skin Conductance Level
Časové okno: 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.
Assessed at the pre and post treatment visits, with the primary outcome being the baseline measures of the variable.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
PTSD Symptom Checklist for the DSM-5 (PCL-5)
Časové okno: 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
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)
Časové okno: 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.
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).
Časové okno: 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.
Assessed at the pre and post treatment visits, with the primary outcome being the baseline measures of the variable.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Coatesville VA Medical Center

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. srpna 2026

Primární dokončení (Odhadovaný)

1. srpna 2029

Dokončení studie (Odhadovaný)

1. srpna 2030

Termíny zápisu do studia

První předloženo

7. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

7. srpna 2026

První zveřejněno (Aktuální)

11. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

11. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 1882489

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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