- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT06549049
Un essai randomisé et contrôlé d'une intervention modifiée sur le sommeil et le rythme circadien chez les vétérans atteints de SSPT : faire progresser la réadaptation psychosociale grâce à la santé du sommeil
Sleep disturbance is a major problem in Veterans with posttraumatic stress disorder (PTSD). This study will test a version of a sleep treatment that's been shown to be effective in the general population, with some changes to tailor it to the needs of Veterans with PTSD and sleep disturbance.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Sleep disturbance in military Veterans with PTSD is a complex condition, typically characterized by insomnia and nightmares, and frequently accompanied by comorbid obstructive sleep apnea. Each of these problems are shown to influence the others, contributing to a complex sleep disturbance with profound impacts on daytime functioning and quality of life. A vicious cycle in which nighttime disturbances impact daytime functioning, and vice versa, often ensues. Addressing sleep disturbance in Veterans with PTSD therefore requires a multipronged approach that is tailored to each Veterans' constellation of symptoms and each Veterans' goals for sleep health. The Transdiagnostic sleep and circadian intervention (TranS-C), developed by sleep researchers Allison Harvey, Ph.D. and Daniel Buysse, M.D., involves a patient-centered, module-based, flexibly structured approach that tackles numerous sleep disturbances using evidence-based strategies with the overall goal of improving sleep and improving sleep-related impairments in daytime functioning. It is thus well-suited for tackling sleep disturbances and the associated impairments in social, occupational and overall functioning in Veterans with PTSD. The proposed study is a randomized, controlled clinical trial examining the effectiveness of a modified TranS-C intervention for Veterans with PTSD. The modified approach, referred to as TranS-C for PTSD (TSC-PTSD) elevates the importance of nightmare-focused, apnea-focused, and insomnia-focused modules relative to the standard intervention, incorporates an evidence-based relaxation module, and modifies the nightmare and apnea modules based on strategies used for Veterans in the VA healthcare system. The study will administer TSC-PTSD remotely to Veterans in their homes using a VA-approved video-conferencing platform. The study will recruit male and female U.S. military Veterans aged 18 and above throughout California and compare change in a comprehensive measure of daytime functioning and change in insomnia, nightmare and overall PTSD symptoms in participants randomized to the active intervention TSC-PTSD vs. participants randomized to a sleep psychoeducation control (SPC) intervention. The widely used and validated World Health Organization Disability Assessment Schedule (WHODAS) will serve as the primary outcome measure. The Insomnia Severity Index (ISI) and the Clinician-Administered PTSD Scale (CAPS) will be used to measure secondary outcomes. Eligible participants will have an insomnia diagnosis, a PTSD diagnosis (or moderate symptoms of PTSD in the absence of a full diagnosis), and clinically significant nightmares based on gold-standard clinician-administered interviews. All participants will complete baseline surveys related to daytime functioning and sleep-related symptoms prior to treatment initiation, and will complete these surveys again in week 5, and at the end of treatment. For additional high-resolution data on sleep patterns, all participants will record sleep-related information, including nightmare occurrence and severity, in the morning and at bedtime using a Veteran-tested and user-friendly sleep diary mobile app. Participants will also complete the clinical interview and self-report surveys at 3-month and 6-month follow-up, to assess the durability of treatment effects. The duration of TSC-PTSD may vary between a minimum of 8 and a maximum of 12 sessions and the psychoeducation control protocol will involve 10 sessions. The hypotheses are: 1) subjects randomized to TSC-PTSD will demonstrate greater improvement in WHODAS score relative to SPC from baseline to post-treatment; 2) subjects randomized to TSC-PTSD will demonstrate greater improvements in insomnia, nightmares and PTSD symptoms as demonstrated by improvements in the ISI, CAPS distressing dreams score, and CAPS total score relative to SPC from baseline to post-treatment; and 3) subjects randomized to TSC-PTSD will demonstrate greater sustained improvement in functional and clinical outcomes at 3-month and 6-month follow-up relative to SPC, and improvements in WHODAS score will be mediated by improvements in ISI, nightmares and TranS-C indicators of sleep health in both study groups. Findings in support of the investigators' hypotheses will provide a vital new tool for advancing rehabilitation in U.S. military Veterans with PTSD.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Emily J Berg
- Numéro de téléphone: (415) 900-6016
- E-mail: emily.berg@va.gov
Lieux d'étude
-
-
California
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San Francisco, California, États-Unis, 94121-1563
- San Francisco VA Medical Center, San Francisco, CA
-
Contact:
- Emily J Berg
- Numéro de téléphone: (415) 900-6016
- E-mail: emily.berg@va.gov
-
Chercheur principal:
- Anne Richards, MD MPH
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- U.S. Military Veteran engaged in VA primary and/or mental health care
- Clinician-Administered post-traumatic stress disorder (PTSD) Scale (CAPS-5) PTSD diagnosis; or CAPS 5 score >=25 in the absence of full criteria
- SCID Insomnia Disorder diagnosis, supported by Insomnia Severity Index (ISI) score >=10
- CAPS-IV nightmare score >=4
- Sleep-related functional impairment based on a World Health Organization Disability Assessment Schedule (WHODAS) score >=32
- Willingness to engage in 8-12 sessions of treatment to address their sleep disturbance
Exclusion Criteria:
- Current cognitive problems, active psychosis or mania, or other mental/cognitive conditions such as moderate to severe neurodegenerative disease that would render the participant unable to connect to videoconferencing platform, engage in remote psychotherapy, or communicate using the required VA secure email platform
- No access to reliable internet service connected to a computer, iPad or similar device (telephone not adequate)
- Inability or unwillingness to use a VA-approved videoconferencing platform and VA secure email
- Current engagement in a sleep-focused psychotherapy, or plan to start a sleep-focused psychotherapy in the next 3 months. Sleep-focused psychotherapies include, but are not limited to, cognitive behavioral therapy for insomnia (CBT-I), brief behavioral treatment for insomnia (BBT-I), and imagery rehearsal therapy (IRT)
Plan d'étude
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: Arm 1: Experimental
Participants receiving experimental TSC-PTSD treatment. |
The Transdiagnostic sleep and circadian intervention (TranS-C), developed by Allison Harvey, Ph.D. and Daniel Buysse, M.D., involves a patient-centered, module-based, flexibly structured approach that tackles numerous sleep disturbances using evidence-based strategies with the goal of improving sleep and related impairments in daytime functioning. It is thus well-suited for tackling sleep disturbances and the associated impairments in social, occupational and overall functioning in Veterans with PTSD. The proposed study is a randomized, controlled clinical trial examining the effectiveness of a modified TranS-C intervention for Veterans with PTSD. The modified approach, TranS-C for PTSD (TSC-PTSD), elevates the importance of nightmare-focused, apnea-focused, and insomnia-focused modules relative to the standard intervention, incorporates an evidence-based relaxation module, and modifies the nightmare and apnea modules based on strategies used for Veterans in the VA healthcare system.
Autres noms:
|
|
Comparateur actif: Arm 2: Active Control
Participants receiving sleep psychoeducation control. |
Participants will receive psychoeducation about sleep.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
World Health Organization Disability Assessment Schedule (WHODAS)
Délai: Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
|
The WHODAS is a validated, comprehensive measure of health-related disability. |
Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Insomnia Severity Index (ISI)
Délai: Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
|
The ISI will be used to measure change in severity of insomnia symptoms. |
Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
|
|
Clinician-Administered PTSD Scale for DSM-4 Distressing Dream Score (CAPS-4 Nightmare Item)
Délai: Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
|
The CAPS-IV Nightmare Item will be used to measure change in nightmare symptoms. |
Week 0, Week 5, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
|
|
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Délai: Week 0, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
|
The CAPS-5 will be used to measure change in overall PTSD symptoms. |
Week 0, Post-Treatment, 3-Month Follow-Up, 6-Month Follow-Up
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Anne Richards, MD MPH, San Francisco VA Medical Center, San Francisco, CA
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Troubles liés aux traumatismes et aux facteurs de stress
- Maladies du système nerveux
- Les troubles mentaux
- Troubles du sommeil et de l'éveil
- Troubles du sommeil, intrinsèques
- Dyssomnies
- Troubles de stress, traumatiques
- Troubles de l'initiation et du maintien du sommeil
- Troubles de stress, post-traumatique
Autres numéros d'identification d'étude
- D4796-R
- 5I01RX004796-02 (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) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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