Clinical trial NCT06149013: Efficacy of MindAhead's Digital Behavioral Activation Therapy in Adults with MCI or Mild Dementia
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Mild Dementia
Keywords: Behavioral Activation Therapy
Active lifestyle intervention
Lead sponsor: MindAhead UG
Sponsor class: INDUSTRY
Collaborators: name: University Medical Center Göttingen
First posted: 2023-11-28
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 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 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)

Primary outcomes:
measure: Overall Quality of Life
timeFrame: 3 months
measure: Activity Level
timeFrame: 3 months
Secondary outcomes:
measure: Disorder-specific quality of life
timeFrame: 3 months
measure: Generic quality of life - composite score
timeFrame: 3 months
measure: Generic quality of life - physical health subscale
timeFrame: 3 months
measure: Generic quality of life - psychological health subscale
timeFrame: 3 months
measure: Generic quality of life - social relationships subscale
timeFrame: 3 months
measure: Generic quality of life - environment subscale
timeFrame: 3 months
measure: Generic quality of life - global subscale
timeFrame: 3 months
measure: Cognitive activity level
timeFrame: 3 months
measure: Physical activity level
timeFrame: 3 months
measure: Social activity level
timeFrame: 3 months
measure: Depressive symptoms
timeFrame: 3 months
measure: Subjective cognitive symptoms - everyday memory
timeFrame: 3 months
measure: Subjective cognitive symptoms - global cognition
timeFrame: 3 months
measure: Chronic disease-specific quality of life
timeFrame: 3 months
measure: Neurocognitive disorder-specific quality of life
timeFrame: 3 months
measure: Goal-oriented activity level
timeFrame: 3 months
measure: Domain-specific activity level
timeFrame: 3 months
Other outcomes:
measure: Daily functioning
timeFrame: 3 months
measure: General patient satisfaction
timeFrame: 3 months
measure: Screening time
timeFrame: 3 months
measure: Recruiting time
timeFrame: 3 months
measure: Inclusion rate
timeFrame: 3 months
measure: Study completion rate
timeFrame: 3 months
measure: Intervention completion rate
timeFrame: 3 months
measure: Completed activity goals
timeFrame: 3 months
measure: App logins / accesses
timeFrame: 3 months
measure: Scheduled activities
timeFrame: 3 months
measure: Major Adverse Events (MAE)
timeFrame: 3 months
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Göttingen
Study officials:
affiliation: University Medical Center Göttingen, Clinic for Psychiatry and Psychotherapy, Germany
name: Jens Wiltfang, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Göttingen, Clinic for Geriatrics, Germany
name: Christine A.F. von Arnim, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: