Recruiting

Stress & Anxiety

Sponsor:

Florida State University

Code:

NCT05748613

Conditions

Anxiety

Mild Cognitive Impairment

Alzheimer Disease

Dementia

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Computerized Anxiety Sensitivity Treatment

Health Education Control

Study Details

Brief summary:

The goal of this clinical trial is to test the effectiveness of a computerized anxiety sensitivity treatment (CAST) compared to a health education control (HEC) in older adults with mild cognitive impairment (MCI) or mild Alzheimer's Disease and related dementias (ADRD) and their care partners. The main questions it aims to answer are:

1. Efficacy of CAST in reducing anxiety and related symptoms among those with MCI/mild ADRD
2. Efficacy of CAST in reducing care partner burden among care partners of people living with MCI/mild ADRD
3. Explore treatment mechanisms using a multi-modal assessment battery of anxiety sensitivity and anxiety

Participants will complete six in-person visits including a baseline assessment, two intervention sessions, and three follow-up assessments at 1, 3, and 6-months posttreatment. Participants will also complete three weeks of ecological momentary assessments (EMAs) for one week prior to intervention, one week between intervention sessions, and one week after intervention.

If there is a comparison group: Researchers will compare CAST to HEC to see if CAST reduces anxiety and related symptoms in older adults with MCI/mild ADRD and care partner burden to a greater degree than HEC.

Conditions

Anxiety

Mild Cognitive Impairment

Alzheimer Disease

Dementia

Study ID

NCT05748613

Start date

Nov 2, 2023

Status verified date

Mar, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

DYAD

  • Patient age 60+
  • Care partner 18+
  • Has care partner who will participate ("someone you have a reciprocal relationship with who provides you with emotional or physical support and helps with decision-making. This could be a spouse or significant other, relative, or close friend whom you spend a significant amount of time with.")
  • Has smartphone or access to Wi-Fi

EITHER

  • Score of 20 or above on the PROMIS-Anxiety short form (patient only) OR
  • Score of 5 or above on SSASI (patient only) OR
  • Score of 31 or above on NIH Toolbox Perceived Stress Scale score (patient only)

AND EITHER

1. Participant MoCA score is between 17 to 26

OR
2. Participant Memory Complaint Scale score 3 or greater

OR
3. Care partner quick dementia rating scale score between 2 to 12.5

Exclusion Criteria:

PATIENT

  • Issues with seeing or hearing that would prevent reading or listening to computer presentations
  • Medical conditions that would preclude participation in study
  • Severe mental illness (e.g., schizophrenia, unmedicated bipolar disorder)

CARE PARTNER

  • Issues with seeing or hearing that would prevent reading or listening to computer presentations
  • Medical conditions that would preclude participation in study
  • Severe mental illness (e.g., schizophrenia, unmedicated bipolar disorder)

Study Design

Enrollment

388 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Computerized Anxiety Sensitivity Treatment

CAST is a transdiagnostic cognitive behavioral therapy (CBT)-based protocol designed to address elevated anxiety sensitivity (AS), particularly the amplification of cognitive stress symptoms including perceived confusion and memory problems. CAST is a fully computerized, 1-hour intervention containing video animation and audio narration throughout, as well as interactive features (e.g., brief quizzes to promote comprehension, introduction and practice with interoceptive exposures). Procedures draw heavily on standard CBT techniques; AS, a core vulnerability for anxiety and depression is targeted using these procedures. In CAST, participants are informed that "the primary purpose of the presentation is to highlight healthier, more productive, and effective ways of dealing with stress." Through participation in the intervention, people learn adaptive long-term strategies for tolerating, coping with, and effectively reducing distress and negative emotions.

placebo comparator: Health Education Control

HEC is a fully computerized 1-hour control condition focused on increasing healthy behaviors and decreasing unhealthy behaviors. Content includes healthy eating, hydration, sleep and rest, exercise, stress management as well as other healthy lifestyle tips. To match the interactive components in the CAST condition, behavior tracking and goal-setting are included in HEC. The HEC protocol has been used in prior studies as a control condition for CAST to account for intervention modality and time. HEC is perceived positively, with high rates of acceptability. Importantly, HEC is inert with respect to the proposed mechanism of action (AS).

Interventions

Computerized Anxiety Sensitivity Treatment

Brief computerized treatment for anxiety sensitivity

Health Education Control

Brief computerized presentation on healthy behaviors

Primary outcome measure

  • Change in anxiety sensitivity pre intervention to posttreatment. [ Time Frame: Baseline to immediately after the intervention ]
  • Change in anxiety pre intervention to 1-month follow-up. [ Time Frame: Baseline to 1-month follow-up ]

Central Contacts and Locations

Central contacts

Norman B Schmidt, Ph.D.

8506451766schmidt@psy.fsu.edu

Frederick T Schubert, B.A.

8045439845schubert@psy.fsu.edu

Locations

Anxiety and Behavioral Health Clinic

Recruiting

Tallahassee, Florida, United States, 32306

Principal Investigator:

Norman B. Schmidt, Ph.D.

Ohio University

Recruiting

Athens, Ohio, United States, 45701

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

More Information

Sponsor

Florida State University

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • Computerized Intervention
  • Brief Treatment
  • Psychoeducation
  • Interoceptive Exposure
  • Older Adults
  • Care Partner
  • Anxiety Sensitivity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Florida State University on 2026-03-05.