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Anxiety Sensitivity Treatment to Reduce Anxiety in Alzheimer's

Treatment of Stress and Anxiety in Mild Cognitive Impairment/Mild Alzheimer's Disease and Related Dementias - RCT

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Baseline assessment will include a neuropsychological evaluation to confirm cognitive status for the older adult with MCI/mild ADRD, a series of baseline questionnaires, and introduction to the EMA application."
  • "At both intervention sessions, dyads complete questionnaires including post assessments at the end of intervention session two."
  • "At 1, 3, and 6-months follow-up assessments, dyads complete follow-up cognitive testing and outcome questionnaires."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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 sites (3)

FL

  • Anxiety and Behavioral Health Clinic · Tallahassee, FL 32306Norman B. Schmidt, Ph.D. · Principal investigatorMore trials in Tallahassee

OH