Terminé

Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families

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Ce qui est testé

Family Supported Prolonged Exposure

+ Standard Prolonged Exposure

Comportemental
Qui peut participer

Troubles liés aux traumatismes et aux facteurs de stress+1

+ Troubles Mentaux

+ Troubles de stress post-traumatique

À partir de 18 ans
+15 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Interventionnel
Date de début : janvier 2018
Voir le détail du protocole

Résumé

Sponsor principalVA Office of Research and Development
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 15 janvier 2018

Date à laquelle le premier participant a commencé l'étude.

Impacts. This study aims to improve Veterans' adherence to evidence-based treatment for PTSD, through increasing family support for treatment. Improving retention rates in evidence-based PTSD treatment will positively impact Veterans' health and well-being, lower the cost of treating PTSD, and decrease long-term demand for PTSD services. If effective, this approach could help resolve national calls for routine inclusion of family involvement in PTSD treatment. Once demonstrated for PTSD, these strategies could be utilized for other conditions and problems relevant to Veteran populations (e.g., suicide prevention, traumatic brain injury (TBI) rehabilitation) and stimulate shifts across practice and policy to better routine and evidence-based involvement of families in care. Background. PTSD occurs in as many as 1 in 5 combat Veterans and is associated with a host of negative, long-term consequences to the individual, their families, and society at large. Evidence-based psychotherapies, such as Prolonged Exposure (PE), result in clinically significant symptom relief for many. Yet, adherence to these treatments (i.e., session attendance and homework compliance), which is vital to ensuring recovery, can be poor. Engaging families in Veterans' treatment may provide a powerful method for promoting EBP adherence. The investigators data indicate that 70% of Veterans express some interest in involving their family in their care for PTSD; yet, only 17% of providers have had any contact with Veterans' families. The objective of the proposed study is to evaluate the effectiveness of improving family support as a tool to improve Veterans' EBP adherence. This research agenda directly addresses two VA HSR\&D priorities: * innovative mental health care; * improving the quality of life for Veterans and their caregivers. The work aligns with the VHA Blueprint for Excellence and Strategic Plan through meeting the unique needs of military-service disabled Veterans, providing a novel treatment approach, and emphasizing patient- and family-centered care. Objectives/Aims. Aim 1: To improve Veterans' adherence to PE through engaging families in care. H1: Veterans randomized to family supported PE will attend more sessions (H1a) and report greater homework compliance (H1b) than Veterans randomized to standard PE delivered in routine care. Aim 2: To improve the clinical outcomes of Veterans receiving PE through engaging families in care. H2: Family supported PE will be more effective than standard PE in reducing PTSD severity and comorbid problems (depression, quality of life, relationship functioning) from baseline to posttreatment. Aim 3: To examine barriers/facilitators of implementing family support for PE. Exploratory Aim: To identify mechanisms underlying adherence differences between treatment conditions. The investigators will explore if adherence differences are mediated by changes on key social influence variables (family perceptions of treatment credibility, family support for PE, and family symptom accommodation). Methods. The investigators are proposing a practical randomized controlled trial to compare Veteran adherence, and to PE with and without family attendance at PE's educational sessions, with the ultimate goal to improve Veterans' clinical outcomes. For Aim 3, the investigators will use a concurrent process evaluation to identify potential implementation facilitators and barriers to family involvement in PE within VA. Participants will include Veterans with clinically significant symptoms of PTSD across three sites, plus a family member or friend of the Veteran. Aim 1 outcome variables include session attendance and homework compliance. Aim 2 outcomes include PTSD symptom severity, depression, quality of life, and relationship functioning, measured monthly over the course of treatment. Key social influences (Exploratory Aim) will be assessed through brief weekly self-reports.

Titre officielImproving Veteran Adherence to Treatment for PTSD Through Partnering With Families
NCT03256227
Sponsor principalVA Office of Research and Development
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

128 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

À partir de 18 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Troubles liés aux traumatismes et aux facteurs de stressTroubles MentauxTroubles de stress post-traumatiqueTroubles liés au stress traumatique

Critères

6 critères d'inclusion nécessaires pour participer
Male or female veterans at least 18 years old. Recruitment is limited to Veterans enrolled in VHA care.

Participant meets DSM-5 diagnostic criteria for PTSD or subthreshold PTSD. Consistent with recommendations, subthreshold PTSD will be defined as endorsement of criteria A (trauma), F (duration), and G (impairment), with at least one symptom from each of the remaining diagnostic criteria (Brancu et al., 2016).

Has an intimate partner, family member, or friend with whom they have contact with at least 3 times a week

Willing to allow this person to participate in the study.

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9 critères d'exclusion empêchent la participation
Moderate relationship violence between the identified support person and the Veteran, defined as one or more episodes of severe violence in the past year (e.g., punched, kicked, or beat up).

Current suicidal or homicidal ideation with intent and/or plan.

Meets DSM-5 criteria for a manic of psychotic episode in the past 3 months.

Meets DSM-5 diagnostic criteria for a severe substance use disorder in the past 3 months. Of note, subjects can be abusing or dependent upon nicotine or marijuana and still be included in the study.

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Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.

Groupe II

Comparateur actif
Standard Prolonged Exposure for PTSD as delivered in routine VA care.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 3 sites

Suspendu

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, United StatesOuvrir Atlanta VA Medical and Rehab Center, Decatur, GA dans Google Maps
Suspendu

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, United States
Suspendu

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, United States
Terminé3 Centres d'Étude
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