- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT05877885
Mirare alla disfunzione della rete nell'apatia della depressione in tarda età utilizzando la terapia digitale
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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Lauren Oberlin, PhD
- Numero di telefono: (860) 690-8441
- Email: lauren.oberlin@adventhealth.com
Luoghi di studio
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Florida
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Orlando, Florida, Stati Uniti, 32804
- Reclutamento
- AdventHealth Neuroscience Institute
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Investigatore principale:
- Lauren Oberlin, PhD
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Contatto:
- Lauren E Oberlin, PhD
- Numero di telefono: (860) 690-8441
- Email: lauren.oberlin@adventhealth.com
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Intervento di training cognitivo mirato
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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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Comparatore attivo: Intervento di formazione cognitiva generale
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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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Resting State Functional Connectivity among the Salience, Executive Control, and Reward Networks
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Apathy Evaluation Scale (AES) score
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Lauren Oberlin, PhD, AdventHealth
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 22-09025304
- K23MH129882 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
The data that will be shared includes all of the individual participant data collected during the trial, after deidentification.
Periodo di condivisione IPD
Beginning 3 months following publication of primary outcomes, ending 5 years following publication of primary outcomes.
Criteri di accesso alla condivisione 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
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- ICF
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
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Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .