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

Last updated: November 11, 2024
Sponsor: MindAhead UG
Overall Status: Completed

Phase

N/A

Condition

Mild Cognitive Impairment

Dementia

Mental Disability

Treatment

Treatment-as-usual

MindAhead Active

Clinical Study ID

NCT06149013
MiMo-P
  • Ages > 50
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of cognitive impairment in MCI stage (ICD-10 codes: F06.7, F07.8) or milddementia stage (ICD-10: F00.-*, F01.-, F03) due to all etiologies apart frometiologies described in F02.- (Pick's disease, Parkinson's disease, multiplesclerosis, Huntington's disease, HIV, Lewy body disease). Hence, etiologies of MCIand 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 neurologistor psychiatrist from our cooperation partners that fulfil adequate diagnosisprocedures such as neuropsychological assessment, brain imaging, self- and/orthird-party medical history interview, and potentially cerebrospinal fluid, positronemission 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 thelast 12 months)

  • Sufficient physical fitness to engage in physical activities (e.g., walking orcycling) as confirmed by a treating physician

  • Age ≥ 50

  • German language skills sufficient to understand German instructions of studyassessments and of the intervention

  • Ability and sufficient vision to operate a smartphone

Exclusion

Exclusion Criteria:

  • possibly moderate or severe cognitive impairment (moderate or severe dementia),indicated by MMSE < 24 or MoCA < 18 (last date of assessment is decisive; needs tobe within the last 12 months)

  • Specific brain injury events within the last 12 months or with ongoing spontaneousremission due to

  • Stroke (ischemic, hemorrhagic)

  • Traumatic brain injury

  • Specific etiologies of MCI or mild dementia (F02.-) that show a variable course or afast 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 understandingwritten German instructions of assessment or intervention procedures (e.g. severeaphasia, lack of sufficient German language skills, severe non-corrected visualimpairment)

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Treatment-as-usual
Phase:
Study Start date:
December 21, 2023
Estimated Completion Date:
October 31, 2024

Study 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 long-term benefits on cognition and daily functioning in patients with MCI and mild dementia. In addition, effects on neuropsychiatric symptoms such as depression are reasonable as behavioral activation therapy has strong and consistent effects on patients with depression. However, effects of a highly scalable, digital version of behavioral activation therapy in patients with MCI or mild dementia are not proven so far. Therefore, this study primarily aims to explore effects of the digital health app MindAhead Active in adults with MCI or mild dementia in a pilot study.

The primary objective of this study is to explore effect sizes in different outcomes (primary outcomes: quality of life, overall activity level) that will be used to calculate the sample size of a larger trial. The secondary objective is the validation of instruments. The investigators aim to validate three questionnaires that may depict outcomes of the full-scale study in case of success.

Further objectives are to assess feasibility regarding the study (recruitment of eligible subjects, online assessment, study completion/dropout rates), and the intervention (app installation, usage and intervention adherence/completion) as well as to confirm findings from previously conducted studies on face-to-face behavioral activation therapy reporting no safety issues and no increase in adverse events in contrast to a control group. This trial is a monocentric, randomized controlled, assessor-blinded superiority trial with two parallel groups.

Connect with a study center

  • University Medical Center Göttingen

    Göttingen,
    Germany

    Site Not Available

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