Cibler le dysfonctionnement du réseau dans l'apathie de la dépression tardive à l'aide de thérapies numériques
The goal of this randomized controlled trial is to evaluate the potential of a customized digital cognitive training intervention to target aspects of brain function in apathy of late-life depression and reduce symptoms of apathy and related cognitive and behavioral deficits. The investigators hypothesize that 4 weeks of a customized digital cognitive training program will lead to changes in brain connectivity, apathy severity, and cognitive control performance.
Aperçu de l'étude
Statut
Statut
Les conditions
Les conditions
Intervention / Traitement
Intervention / Traitement
Type d'étude
Type d'étude
Inscription (Estimé)
Inscription
Phase
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
Coordonnées de l'étude
- Nom: Lauren Oberlin, PhD
- Numéro de téléphone: (860) 690-8441
- E-mail: lauren.oberlin@adventhealth.com
Lieux d'étude
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Florida
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Orlando, Florida, États-Unis, 32804
- Recrutement
- AdventHealth Neuroscience Institute
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Chercheur principal:
- Lauren Oberlin, PhD
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Contact:
- Lauren E Oberlin, PhD
- Numéro de téléphone: (860) 690-8441
- E-mail: lauren.oberlin@adventhealth.com
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-
Critères de participation
Critère d'éligibilité
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age 60+ years
- Diagnosis of unipolar major depressive disorder without psychotic features, as assessed by the Mini International Neuropsychiatric Interview
- Montgomery-Åsberg Depression Rating Scale (MADRS) score > or = 16.
- Clinically significant apathy, determined by the Clinician-rated Apathy Evaluation Scale (C-AES > or = to 37)
- Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 5 weeks.
- On a stable dose of other psychotropic medications, deemed by the investigator to be associated with brain networks of interest, for at least 8 weeks.
- Capacity to provide written consent for research assessment and treatment
- Ability to follow written and verbal instructions (English) as assessed by the PI and/or study staff.
- Total score of > 29 on the Telephone Interview for Cognitive Status (TICS)
- Eligible to undergo MRI
- Access to a computer or tablet with Wifi capabilities
- Able to comply with all testing and study requirements and willingness to participate in the full study duration.
Exclusion Criteria:
- History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, persistent depressive disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia
- Use of cholinesterase inhibitors or psychoactive drugs other than antidepressants or benzodiazepines, including antipsychotics, that in the opinion of the Investigator may confound study data/assessments.
- Presence or history of significant neurologic or neurodegenerative disorder (e.g., Alzheimer's disease and other dementias, amnestic Mild Cognitive Impairment, history of stroke, Multiple Sclerosis, Parkinson's disease, epilepsy).
- Any other acute medical condition (e.g., cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease; metastatic cancer; or debilitated states or less common medical illnesses) that may influence brain systems of interest or interfere with participation or interpretation of the study results.
- Participant is currently considered at risk for attempting suicide by the Investigator, has made a suicide attempt within the past year, or is currently demonstrating active suicidal ideation or self-injurious behavior.
- Electroconvulsive therapy within the past 12 months
- Recent history (within 6 months prior to screening/baseline) of Substance Use Disorder.
- Participant is currently enrolled in ongoing concurrent cognitive rehabilitation (note that if a subject is enrolled in psychotherapy, this will not be grounds for exclusion)
- Claustrophobia
- Color Blindness
- Sensory or physical impairment that would preclude cognitive testing or participation in the intervention (e.g., upper limb paralysis) as reported by the participant or observed by the Investigator.
- Travelling consecutively for 2+ weeks during the study period to a location that will preclude timely collection of post-treatment MRI data.
- Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, cochlear implant, any other metallic biomedical implant contraindicating to MRI.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Nombre de bras
Armes et Interventions
Groupe de participants / BrasGroupe de participants / Bras |
Intervention / TraitementIntervention / Traitement |
|---|---|
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Expérimental: Intervention d'entraînement cognitif ciblée
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In this intervention, participants will complete 25-30 minutes of cognitive training per day, 5 days/week (but up to 7 days/week) for 4 weeks. The training protocol will be delivered via the Posit Science Platform, and includes tasks that emphasize training of sustained attention, salience detection, and dimensions of cognitive control. During the 4 week intervention, participants will have weekly 10-20 minute visits with a Care Manager to provide clinical monitoring of symptoms and structured support to participants. |
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Comparateur actif: Intervention d'entraînement cognitif général
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In this intervention, participants will complete 25-30 minutes of cognitive activities per day, 5 days/week (but up to 7 days/week) for 4 weeks. The training protocol will be delivered via the Posit Science Platform. The intervention protocol will include computerized cognitive activities designed to provide general cognitive stimulation. During the 4 week intervention, participants will have weekly 10-20 minute visits with a Care Manager to provide clinical monitoring of symptoms and structured support to participants. |
Que mesure l'étude ?
Principaux critères de jugement
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Resting State Functional Connectivity among the Salience, Executive Control, and Reward Networks
Délai: Baseline and Post-treatment (Week 4)
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Calculated from resting state fMRI scan. Validation of target engagement. |
Baseline and Post-treatment (Week 4)
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Mesures de résultats secondaires
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Apathy Evaluation Scale (AES) score
Délai: Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4)
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The 18-item clinician-rated version of the Apathy Evaluation Scale (AES) will be used to measure apathy severity. Scores range from 18 (no apathy) to 72 (severe apathy). |
Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4)
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Change in Stroop Interference score
Délai: Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4)
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Stroop interference will be calculated from the computerized Stroop Task to measure cognitive control. |
Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4)
|
Collaborateurs et enquêteurs
Parrainer
Parrainer
Collaborateurs
Collaborateurs
Les enquêteurs
Les enquêteurs
- Chercheur principal: Lauren Oberlin, PhD, AdventHealth
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Début de l'étude
Achèvement primaire (Estimé)
Achèvement primaire
Achèvement de l'étude (Estimé)
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Première publication
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour publiée
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
Autres numéros d'identification d'étude
- 22-09025304
- K23MH129882 (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) ?
Description du régime IPD
The data that will be shared includes all of the individual participant data collected during the trial, after deidentification.
Délai de partage IPD
Beginning 3 months following publication of primary outcomes, ending 5 years following publication of primary outcomes.
Critères d'accès au partage IPD
Data will be made available to researchers who provide a methodologically sound proposal, to achieve the aims in the approved proposal. Proposals should be directed to the study PI, Lauren Oberlin, at lauren.oberlin@adventhealth.com
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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