NCT05690243

Minds Navigating the Diagnosis of Mild Cognitive Impairment

Minds Navigating the Diagnosis of Mild Cognitive Impairment (MiND-MCI)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Tuscaloosa Research & Education Advancement Corporation · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to find out if a 9 week group therapy using video from home will help veterans with Mild Cognitive Impairment (MCI). The main questions it aims to answer are: * is the video therapy user-friendly for veterans? * does it improve veterans well-being and quality-of-life? Veterans will be asked to attend nine 1 hour small group video sessions and will complete questionnaires before and after the sessions. Researchers will compare the group of veterans that starts the video sessions right away with a group that waits before starting the video sessions.

Detailed description

The study will be achieved by conducting a two-arm, single-blind, pilot randomized controlled trial at two VA medical centers. Eighty participants at each site will be randomized in a 1:1 ratio to either the MiND-MCI group or waitlist control group. Participants will be Veterans ages 60 and older with a diagnosis of MCI, at least one cardiovascular risk factor, self-reported cognitive complaint, and self-reported difficulty adjusting to MCI diagnosis or symptoms. MiND-MCI will be delivered in nine weekly 60-minute sessions via telehealth in groups of 5 to 7 Veterans. Feasibility and acceptability process data will be tracked throughout the study. Acceptability measures pertaining to participants' perceptions of MiND-MCI will be collected at post-treatment using quantitative and qualitative assessment methods. Outcome measures collected at baseline, post-treatment, and 12-week follow-up will assess global QoL, MCI-related QoL, MCI-related self-efficacy, depression, anxiety, loneliness, coping, and cognitive functioning.

Conditions

• Cognitive Dysfunction
• Mild Cognitive Impairment

Interventions

Type	Name	Description
BEHAVIORAL	Group psychotherapy delivered via video telehealth	Small group psychotherapy using psychoeducation and skills training aimed at addressing modifiable factors in MCI.

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-07-31
• Completion: 2025-09-30
• First posted: 2023-01-19
• Last updated: 2023-11-24

Locations

2 sites across 1 country: United States