NCT06149013

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: MindAhead UG · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
OTHER	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.

Timeline

• Start date: 2023-12-21
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2023-11-28
• Last updated: 2024-11-13

Locations

1 site across 1 country: Germany