Status:
COMPLETED
Efficacy of MindAhead's Digital Behavioral Activation Therapy in Adults with MCI or Mild Dementia
Lead Sponsor:
MindAhead UG
Collaborating Sponsors:
University Medical Center Göttingen
Conditions:
Mild Cognitive Impairment
Mild Dementia
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Face-to-face behavioral activation therapy focusing on meaningful and enjoyable, physical, cognitive and social activities has shown positive effects on quality of life and activity level as well as l...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
December 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06149013
Start Date
December 21 2023
End Date
October 31 2024
Last Update
November 13 2024
Active Locations (1)
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1
University Medical Center Göttingen
Göttingen, Germany