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Une intervention de santé mobile pour améliorer le fonctionnement psychosocial chez les vétérans souffrant de trouble de stress post-traumatique et de symptômes de dépression

1 octobre 2026 mis à jour par: VA Office of Research and Development

Posttraumatic stress disorder (PTSD) and depression are the two most common mental health conditions among Veterans. When Veterans experience both, there is a negative impact on their functioning, making it difficult to function at work or at home and socially with other people. Although talk therapies can result in improvements in functioning, they are difficult to access because there are limited clinicians who can provide them. As most US adults now own a smartphone, mobile apps are a way for Veterans to access content traditionally delivered through talk therapies at their own pace. This study will test a mobile app based on a trauma-informed talk therapy that has helped Veterans with PTSD and depression make large improvements in functioning, through learning skills to navigate emotions and relationships. Additionally, through answering brief surveys and enabling passive tracking on their smartphones, Veterans will see real-time information on their functioning and mental health and on potential benefits from using these skills.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

Veterans experience high rates of posttraumatic stress disorder (PTSD) and depression, which are frequently comorbid and result in difficulties with psychosocial functioning substantially greater than either disorder alone. Functioning difficulties in Veterans have not been adequately addressed by most existing psychotherapies for PTSD and depression because they often focus on symptom improvement and are highly resource-intensive, requiring the training and time of skilled providers. To address this gap, mobile health (mHealth) apps can serve as a widely accessible, standalone or adjunctive intervention to target psychosocial functioning among Veterans with comorbid PTSD and depression. This study focuses on the evaluation of a self-guided mHealth intervention based on Skills Training in Affective and Interpersonal Regulation (STAIR), an evidence-based psychotherapy that explicitly targets functioning improvements and also alleviates PTSD and depression symptoms among trauma survivors. As part of the intervention, real-time assessment (i.e., ecological momentary assessment and passive sensing) will be incorporated to support Veterans in monitoring their functioning, symptoms, and potential benefits from STAIR. The primary goal is to determine the feasibility and acceptability of this intervention (self-guided STAIR Coach with real-time assessment).

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • California
      • Palo Alto, California, États-Unis, 94304-1207
        • VA Palo Alto Health Care System, Palo Alto, CA
        • Contact:
        • Chercheur principal:
          • Haijing Wu Hallenbeck, PhD MA

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Veteran
  • enrolled in VA care
  • fluent in English
  • able to provide informed consent
  • own a smartphone or willing to use a study-provided smartphone
  • have diagnoses of current posttraumatic stress disorder (PTSD) and major depressive disorder (MDD)
  • willing to not begin another form of Skills Training in Affective and Interpersonal Regulation (STAIR) during the study

Exclusion Criteria:

  • history of mania or psychosis
  • current suicidal ideation with plan and intent to harm self
  • acute intoxication from alcohol or other substances
  • current or past experience with any form of STAIR

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Self-Guided STAIR Coach with Real-Time Assessment

Participants randomized to this condition will receive two mobile apps.
Autre: Self-Guided STAIR Coach with Real-Time Assessment

Two mobile apps to be used as one intervention package to support participants in their progress through STAIR (Skills Training in Affective and Interpersonal Regulation) with self-monitoring of symptoms and functioning
Comparateur actif: Real-Time Assessment

Participants randomized to this condition will receive one mobile app.
Autre: Real-Time Assessment

One mobile app to support participants in self-monitoring of symptoms and functioning

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Study Recruitment Rate
Délai: Evaluated at end of trial (lasting approximately 2 years)

Recruitment rate will be calculated as the number of participants who are eligible for the study divided by the number of screened participants. Target feasibility benchmark is 50%.
Evaluated at end of trial (lasting approximately 2 years)
Study Retention Rate
Délai: Evaluated at end of trial (lasting approximately 2 years)

Retention rate will be calculated as the number of participants who completed the full study divided by the total number of enrolled participants. Target feasibility benchmark is 70%.
Evaluated at end of trial (lasting approximately 2 years)
Study Engagement Rate
Délai: Evaluated at end of trial (lasting approximately 2 years)

Engagement rate will refer to the mean percentage of completed STAIR Coach training plan levels and completed EMA surveys. Target feasibility benchmark is 70%.
Evaluated at end of trial (lasting approximately 2 years)
Mobile Application Rating Scale User Version (uMARS)
Délai: Post-treatment (i.e., 12 weeks after starting the trial)

App quality will be assessed through the Mobile Application Rating Scale User Version (uMARS). Total scores on the uMARS range from 1 to 5, with higher scores indicating higher quality. Target acceptability benchmark is a uMARS mean score of greater than or equal to 4 (indicating positive app quality).
Post-treatment (i.e., 12 weeks after starting the trial)
Client Satisfaction Questionnaire-8 (CSQ-8)
Délai: Post-treatment (i.e., 12 weeks after starting the trial)

Client satisfaction will be assessed through the Client Satisfaction Questionnaire-8 (CSQ-8). Total scores on the CSQ-8 range from 8 to 32, with higher scores indicating higher satisfaction. Acceptability benchmark is a CSQ-8 mean score of greater than or equal to 24 (indicating general treatment satisfaction).
Post-treatment (i.e., 12 weeks after starting the trial)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
PTSD Checklist for DSM-5 (PCL-5)
Délai: Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)

PTSD symptoms will be assessed through the PTSD Checklist for DSM-5 (PCL-5). Total scores on the PCL-5 range from 0 to 80, with higher scores indicating greater PTSD symptoms. The focus will be on evaluating effect sizes and not statistical significance. Effect sizes will be inspected to see whether they are in the expected direction and larger for the intervention condition compared to the control condition.
Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)
Patient Health Questionnaire-9 (PHQ-9)
Délai: Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)

Depression symptoms will be assessed through the Patient Health Questionnaire-9 (PHQ-9). Total scores on the PHQ-9 range from 0 to 27, with higher scores indicating greater depression symptoms. The focus will be on evaluating effect sizes and not statistical significance. Effect sizes will be inspected to see whether they are in the expected direction and larger for the intervention condition compared to the control condition.
Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Délai: Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)

Psychosocial functioning impairment will be assessed through the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Total scores on the WHODAS 2.0 range from 0 to 144, with higher scores indicating greater functioning impairment. The focus will be on evaluating effect sizes and not statistical significance. Effect sizes will be inspected to see whether they are in the expected direction and larger for the intervention condition compared to the control condition.
Baseline, midpoint, post-treatment, follow-up (i.e., 0 weeks, 6 weeks, 12 weeks, and 18 weeks after starting the trial, respectively)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

VA Office of Research and Development

Les enquêteurs

  • Chercheur principal: Haijing Wu Hallenbeck, PhD MA, VA Palo Alto Health Care System, Palo Alto, CA

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 avril 2027

Achèvement primaire (Estimé)

1 avril 2029

Achèvement de l'étude (Estimé)

1 avril 2029

Dates d'inscription aux études

Première soumission

12 novembre 2024

Première soumission répondant aux critères de contrôle qualité

12 novembre 2024

Première publication (Réel)

14 novembre 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 octobre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • D5318-W
  • IK2RX005318-01A1 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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