Recruiting

Observational Study

Sponsor:

Tuscaloosa Research & Education Advancement Corporation

Code:

NCT05690243

Conditions

Cognitive Dysfunction

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Group psychotherapy delivered via video telehealth

Study Details

Brief 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.

Conditions

Cognitive Dysfunction

Mild Cognitive Impairment

Study ID

NCT05690243

Start date

Oct 1, 2023

Status verified date

Nov, 2023

Completion date

Sep 30, 2025

Anticipated

Primary completion date

Jul 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Veteran
  • age 60 or older
  • diagnosis of MCI, diagnosed at least a month or longer prior to screening
  • diagnosis of at least one cardiovascular risk factor (i.e., hypertension, diabetes mellitus II, hyperlipidemia/hypercholesterolemia, or obesity)
  • self-reported cognitive complaint (i.e., "Do you have problems with your memory or thinking abilities?")
  • self-reported difficulty adjusting to declines in cognitive functioning (i.e., "Have these problems with memory or thinking impacted you, your life, or others in your life?")
  • English speaking, and (h) ability to provide written informed consent

Exclusion Criteria:

  • diagnosis of dementia or a neurodegenerative disorder
  • diagnosis of serious mental illness likely to impact cognition (i.e., schizophrenia or bipolar I disorder)
  • acutely suicidal or homicidal
  • actively psychotic
  • active substance use disorder
  • limited life expectancy due to a terminal medical condition
  • receiving ongoing chemotherapy or radiation treatment at time of screening
  • residing in an assisted living or residential care facility
  • currently participating in another psychotherapy, health promotion intervention, or cognitive training program, and
  • any significant changes to psychotropic medications or medications for memory and cognition in the past month. Participants prescribed psychotropic medications and medications for memory and cognition will be asked to stay on their current dosages for the duration of the study.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group therapy delivered via video telehealth

Nine sessions of 60 min each group therapy delivered via telehealth

other: Group therapy delivered via video telehealth - wait list control

Nine sessions of 60 min each group therapy delivered via telehealth after a waiting period.

Interventions

Group psychotherapy delivered via video telehealth

Small group psychotherapy using psychoeducation and skills training aimed at addressing modifiable factors in MCI.

Primary outcome measure

  • Feasibility of a group video-telehealth intervention for veterans with MCI [ Time Frame: At Week 0 (randomization) ]
  • Acceptability of a group video-telehealth intervention for veterans with MCI [ Time Frame: At Week 10 (one week after completion of the 9 video-telehealth sessions) ]

Central Contacts and Locations

Central contacts

Patricia Pilkinton, MD

205-554-20944patricia.pilkinton@va.gov

Lindsay Jacobs, PhD

205-554-2337jacob008@ua.edu

Locations

Tuscaloosa VA Medical Center

Recruiting

Tuscaloosa, Alabama, United States, 35404

Contacts

Patricia Pilkinton, MD

205-554-2944patricia.pilkinton@va.gov

Salem VA Medical Center

Recruiting

Salem, Virginia, United States, 24153

Contacts

Katherine Luci, PsyD

540-982-2463Katherine.luci@va.gov

More Information

Sponsor

Tuscaloosa Research & Education Advancement Corporation

Last update posted

Nov 24, 2023

Last verified

Nov, 2023

Keywords

  • therapy
  • video telehealth
  • veteran

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tuscaloosa Research & Education Advancement Corporation on 2023-11-24.