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

Mild Cognitive Impairment Clinical Trial

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)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment
• Mild Dementia

• NCT number: NCT06149013
• Study type: Interventional
• Source: MindAhead UG
• Contact: Patrick Fissler, Dr.
• Phone: 0041-581444347
• Email: Patrick.fissler@mindahead.de
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2023
• Completion date: June 15, 2024