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Efficacy of MindAhead's Digital Behavioral Activation Therapy in Adults with MCI or Mild Dementia

A legfontosabb adatok

Ki végzi
MindAhead UG
Hol
Németország1 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Befejeződött
Résztvevők
50 fő vett részt
Kezdés
2023. dec. 21.
Befejezés
2024. okt. 31.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • MindAhead Active
  • Treatment-as-usual
A regiszteradat frissítve
2024. november 13.

Ki vehet részt

Életkor
50 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 12 feltétel megnézéseKevesebb

Ki vehet részt

  • Diagnosis of cognitive impairment in MCI stage (ICD-10 codes: F06.7, F07.8) or mild dementia stage (ICD-10: F00.-*, F01.-, F03) due to all etiologies apart from etiologies described in F02.- (Pick's disease, Parkinson's disease, multiple sclerosis, Huntington's disease, HIV, Lewy body disease). Hence, etiologies of MCI and mild dementia include; Alzheimer's disease (e.g., F00.-*); Vascular disease (e.g., F01.-) (exception in case of stroke: event occurred > 12 months ago without ongoing spontaneous remission); Mixed diseases; Unclear etiologies
  • MCI or mild dementia diagnosis assigned within the last 12 months by a neurologist or psychiatrist from our cooperation partners that fulfil adequate diagnosis procedures such as neuropsychological assessment, brain imaging, self- and/or third-party medical history interview, and potentially cerebrospinal fluid, positron emission tomography, or electrophysiological measures
  • MCI or mild dementia diagnosis confirmed by a treating physician
  • MMSE ≥ 24 or MoCA ≥ 18 (last date of assessment is decisive; needs to be within the last 12 months)
  • Sufficient physical fitness to engage in physical activities (e.g., walking or cycling) as confirmed by a treating physician
  • Age ≥ 50
  • German language skills sufficient to understand German instructions of study assessments and of the intervention
  • Ability and sufficient vision to operate a smartphone

Ki nem vehet részt

  • possibly moderate or severe cognitive impairment (moderate or severe dementia), indicated by MMSE < 24 or MoCA < 18 (last date of assessment is decisive; needs to be within the last 12 months)
  • Specific brain injury events within the last 12 months or with ongoing spontaneous remission due to; Stroke (ischemic, hemorrhagic); Traumatic brain injury
  • Specific etiologies of MCI or mild dementia (F02.-) that show a variable course or a fast progression including; Multiple sclerosis; Parkinson's disease; Pick's disease / Frontotemporal lobar degeneration; Lewy body disease; Brain tumors; Autosomal dominant form of Alzheimer's disease with early first manifestation; Creutzfeldt-Jakob disease
  • German language restrictions or visual restrictions which prevent from understanding written German instructions of assessment or intervention procedures (e.g. severe aphasia, lack of sufficient German language skills, severe non-corrected visual impairment)

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A vizsgálatról

Mit akar kideríteni a vizsgálat

This pilot study investigates effects of a digital behavioral activation therapy in treating patients with mild cognitive impairment and mild dementia, applying a randomized controlled parallel group design. The primary goal is to estimate effect sizes for a larger trial. A further aim is to investigate the feasibility of study procedures and to validate new questionnaire scores. Primary outcomes are the change in the patients' quality of life and in their overall activity level.

A vizsgálat 2 csoportja

  • MindAhead + TAU GroupA vizsgált kezelés

    The intervention group receives the digital health app MindAhead Active for 3 months as well as treatment-as-usual (TAU, see Control intervention).

    Kezelés: MindAhead Active és Treatment-as-usual

  • TAU GroupMár használt kezelés, összehasonlításként

    The control group receives TAU which may include antidementive medication (e.g., acetylcholinesterase inhibitors), advice on protective lifestyle factors, vitamin supplementation, ergotherapy, cognitive training (including digital health apps), or statins depending on clinical findings.

    Kezelés: Treatment-as-usual

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Efficacy of MindAhead's Digital Behavioral Activation Therapy in Adults with Mild Cognitive Impairment or Mild Dementia: a Monocentric Randomized Controlled Pilot Trial (MindMoments-Pilot)
A regiszteradat frissítve
2024. november 13.