Augmented Depression Therapy (ADepT) Case Series
28 juillet 2026 mis à jour par: Jay Fournier, Ohio State University
This research study plans to examine the use of Augmented Depression Therapy (ADepT) in order to evaluate what patients think about ADepT and how well it works. ADepT is a type of therapy that builds wellbeing and is being provided to you as standard of care.
ADepT treatment consists of 15 therapy sessions (typically provided weekly) with each session lasting around 60 minutes. Following these sessions, you can receive five optional booster sessions over the next 12 months with each of these lasting around 60 minutes. Ultimately, the timing and duration of these sessions will be determined between you and your provider and scheduled accordingly.
As part of this study you will be randomized (randomly assigned) to different research assessment lengths before the start of treatment and then will complete assessments for the 12 months following the end of the weekly portion of ADepT treatment. The length of your participation will be between 70 weeks to 82 weeks.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
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
- Nom: Jay Fournier, Ph.D.
- Numéro de téléphone: 614-814-6485
- E-mail: Jay.Fournier@osumc.edu
Lieux d'étude
-
-
Ohio
-
Columbus, Ohio, États-Unis, 43214
- The Ohio State University Wexner Medical Center
-
Contact:
- Jay Fournier, PhD
- Numéro de téléphone: 614-814-6485
- E-mail: jay.fournier@osumc.edu
-
-
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
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Aged 18 -65
- Currently experiencing a major depressive episode based on the Quick Structured Clinical Interview for DSM-5 Disorders (QuickSCID-5; First & Williams, 2021)
- Scoring > 10 on the PHQ-9
- Have sufficient knowledge of written and spoken English to provide consent and utilize therapy resources and take assessment measures throughout the protocol without the assistance of a translator.
Exclusion Criteria:
- Diagnosis of a psychotic or bipolar disorder
- History of learning disabilities or organic brain change (e.g., from injury or from neurological disorders)
- Active alcohol or substance use disorder or level of use that would interfere with ability to engage in ADepT treatment
- Current marked risk to self (self-harm or suicidal ideation) that cannot be managed safely within the ADepT treatment frame
- Patients cannot be enrolled while they are currently receiving psychotherapy from a different provider in line with current clinic policy and APA ethical guidelines. The possibility of switching providers/treatments will be addressed following established departmental policies and procedures, transcranial magnetic stimulation, ketamine, esketamine, or electroconvulsive therapy. Patients receiving a stable dose of an antidepressant agent will be considered eligible.
- Presence of another psychiatric disorder judged to be primary
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 à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 3 week baseline + ADepT
Baseline assessments will be made weekly for 3 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
Expérimental: 4 week baseline + ADepT
Baseline assessments will be made weekly for 4 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
Expérimental: 5 week baseline + ADepT
Baseline assessments will be made weekly for 5 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
Expérimental: 6 week baseline + ADepT
Baseline assessments will be made weekly for 6 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
Expérimental: 7 week baseline + ADepT
Baseline assessments will be made weekly for 7 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
|
Expérimental: 8 week baseline + ADepT
Baseline assessments will be made weekly for 8 weeks, followed by a standard course of ADepT.
|
ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing.
It consists of 15 acute treatment sessions and up to 5 booster sessions.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Acceptability
Délai: From enrollment to the end of treatment at 82 weeks
|
Patient ratings of treatment acceptability
|
From enrollment to the end of treatment at 82 weeks
|
|
Attrition
Délai: From enrollment to the end of treatment at 82 weeks.
|
Patient attendance records
|
From enrollment to the end of treatment at 82 weeks.
|
|
Adverse Events
Délai: From enrollment to the end of treatment at 82 weeks.
|
Self-reported adverse events
|
From enrollment to the end of treatment at 82 weeks.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
Délai: From enrollment to the end of treatment at 82 weeks.
|
The MADRS is a clinician-administered, 10-item assessment tool used to measure the severity of depressive symptoms and monitor changes in depression over time.
Min=0, Max=60, higher scores indicate worse depression.
|
From enrollment to the end of treatment at 82 weeks.
|
|
Patient Health Questionnaire - 9 Item Version (PHQ-9)
Délai: From enrollment to the end of treatment at 82 weeks.
|
The PHQ-9 is a 9-item self-report measure of depression severity.
Min=0, Max=27, higher scores indicate worse depression.
|
From enrollment to the end of treatment at 82 weeks.
|
|
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Délai: From enrollment to the end of treatment at 82 weeks.
|
The WEMWBS is a 14-item self-report questionnaire designed to measure positive mental wellbeing, including emotional, psychological, and social functioning.
Min=14, Max=70, higher scores indicate higher levels of wellbeing.
|
From enrollment to the end of treatment at 82 weeks.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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 août 2026
Achèvement primaire (Estimé)
31 août 2028
Achèvement de l'étude (Estimé)
31 décembre 2028
Dates d'inscription aux études
Première soumission
23 juillet 2026
Première soumission répondant aux critères de contrôle qualité
28 juillet 2026
Première publication (Réel)
29 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20251473
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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Description du régime IPD
Only IRB approved personnel will have access to identifiable data.
De-identified data may be shared with other research groups examining similar questions or as a requirement for publication in certain journals.
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
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 .