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

NCT ID: NCT06149013

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-21
• Study Completion Date: 2024-10-31

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.

Conditions

Mild Cognitive Impairment; Mild Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MindAhead + TAU Group

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

Group Type: EXPERIMENTAL

MindAhead Active

Intervention Type: DEVICE

MindAhead's Active app focuses on increasing meaningful and enjoyable cognitive, physical, and social activities specifically adapted to patients with early cognitive decline (MCI or mild dementia). These techniques include psychoeducation (explaining the rationale, the components of behavioral activation, and protective activities), action planning (selecting activities, goal setting, activity scheduling, graded task assignment, written schedules, and step-by-step sequencing) and action/self-monitoring (assessing execution of and enjoyment in activities, monitor mood and cognitive problems), as well as value-based activation (understanding most important values, selecting activities according to these values). This process aims to enable the users to understand which activities are enjoyable and meaningful to them and how to implement these activities into their daily lives. MindAhead's Active app consists of one to five sessions per week.

Treatment-as-usual

Intervention Type: OTHER

Depending on patient-specific clinical findings it includes antidementive medication (e.g., acetylcholinesterase inhibitors), advice on protective lifestyle factors, vitamin supplementation, ergotherapy, cognitive training (including digital health apps), or statins.

TAU Group

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.

Group Type: ACTIVE_COMPARATOR

Treatment-as-usual

Intervention Type: OTHER

Depending on patient-specific clinical findings it includes antidementive medication (e.g., acetylcholinesterase inhibitors), advice on protective lifestyle factors, vitamin supplementation, ergotherapy, cognitive training (including digital health apps), or statins.

Interventions

MindAhead Active

MindAhead's Active app focuses on increasing meaningful and enjoyable cognitive, physical, and social activities specifically adapted to patients with early cognitive decline (MCI or mild dementia). These techniques include psychoeducation (explaining the rationale, the components of behavioral activation, and protective activities), action planning (selecting activities, goal setting, activity scheduling, graded task assignment, written schedules, and step-by-step sequencing) and action/self-monitoring (assessing execution of and enjoyment in activities, monitor mood and cognitive problems), as well as value-based activation (understanding most important values, selecting activities according to these values). This process aims to enable the users to understand which activities are enjoyable and meaningful to them and how to implement these activities into their daily lives. MindAhead's Active app consists of one to five sessions per week.

Intervention Type: DEVICE

Treatment-as-usual

Depending on patient-specific clinical findings it includes antidementive medication (e.g., acetylcholinesterase inhibitors), advice on protective lifestyle factors, vitamin supplementation, ergotherapy, cognitive training (including digital health apps), or statins.

Intervention Type: OTHER

Other Intervention Names

MindAhead's Behavioral Activation Therapy; TAU

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)

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Göttingen

UNKNOWN

Sponsor Role: collaborator

MindAhead UG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jens Wiltfang, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Göttingen, Clinic for Psychiatry and Psychotherapy, Germany

Christine A.F. von Arnim, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Göttingen, Clinic for Geriatrics, Germany

Locations

University Medical Center Göttingen

Göttingen, , Germany

Countries

Germany

Other Identifiers

MiMo-P

Identifier Type: -

Identifier Source: org_study_id