Treatment of Stress and Anxiety in MCI/Mild ADRD

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05748613
• Other study ID #: STUDY00003432
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2023
• Est. completion date: January 2028

Study information

• Verified date: December 2023
• Source: Florida State University
• Contact: Norman B Schmidt, Ph.D.
• Phone: 8506451766
• Email: schmidt[@]psy.fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Participants are dyads consisting of an older adult with MCI/mild ADRD and their care partner. 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. Dyads are randomized to either the CAST or HEC conditions. During CAST sessions, dyads view the CAST presentation and complete interoceptive exposures. An interventionist guides dyads through these sessions. During HEC, dyads view the HEC presentation and complete behavior tracking and goal-setting with the guidance of an interventionist. At both intervention sessions, dyads complete questionnaires including post assessments at the end of intervention session two. For the week prior to intervention session one, the week between the two intervention sessions, and the week after intervention session two, dyads complete daily EMAs about emotional and other factors using an application downloaded on a phone or tablet. At 1, 3, and 6-months follow-up assessments, dyads complete follow-up cognitive testing and outcome questionnaires.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 388
• Est. completion date: January 2028
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.")

• Score of 22 or above on the PROMIS-Anxiety short form (patient only)

• Score of 5 or above on SSASI (patient only)

• Has smartphone or access to Wi-Fi

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Anxiety
• Anxiety Disorders
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

Behavioral:
• Computerized Anxiety Sensitivity Treatment
Brief computerized treatment for anxiety sensitivity
• Health Education Control
Brief computerized presentation on healthy behaviors

Locations

Country	Name	City	State
United States	Ohio University	Athens	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Anxiety and Behavioral Health Clinic	Tallahassee	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Florida State University	Ohio State University, Ohio University

Country where clinical trial is conducted

United States, 

References & Publications (19)

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Zvolensky MJ, Garey L, Fergus TA, Gallagher MW, Viana AG, Shepherd JM, Mayorga NA, Kelley LP, Griggs JO, Schmidt NB. Refinement of anxiety sensitivity measurement: The Short Scale Anxiety Sensitivity Index (SSASI). Psychiatry Res. 2018 Nov;269:549-557. doi: 10.1016/j.psychres.2018.08.115. Epub 2018 Aug 29. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anxiety sensitivity pre intervention to posttreatment.	Anxiety sensitivity will be measured using the Anxiety Sensitivity Index-3 (ASI-3). The ASI-3 is an 18-item self report measure with possible scores ranging from 0 to 72. Higher scores indicate higher anxiety sensitivity.	Baseline to immediately after the intervention
Primary	Change in anxiety pre intervention to 1-month follow-up.	Anxiety will be assessed using the Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS Anxiety) Short Form 8a self-report measure. The PROMIS Anxiety is an 8-item self report questionnaire with possible scores ranging from 8 to 40. Higher scores indicate more anxiety.	Baseline to 1-month follow-up
Secondary	Change in negative affect pre intervention to 1-month follow-up.	Negative affect will be assessed using the Positive and Negative Affect Schedule - Negative Affect (PANAS-NA). PANAS-NA is a 10-item self-report measure with possible scores ranging from 10 to 50. Higher scores indicate more negative affect.	Baseline to 1-month follow-up
Secondary	Change in stress pre intervention to 1-month follow-up.	Stress will be assessed with the NIH Toolbox - Perceived Stress. The NIH Toolbox - Perceived Stress is a 10-item self-report measure with possible scores ranging from 10 to 50. Higher scores indicate more stress.	Baseline to 1-month follow-up
Secondary	Change in quality of life pre intervention to 1-month follow-up.	Quality of life will be assessed with the NIH Toolbox General Life Satisfaction scale. The NIH Toolbox General Life Satisfaction scale is a 5-item self-report measure with possible scores ranging from 5 to 35. Higher scores indicate higher life satisfaction.	Baseline to 1-month follow-up
Secondary	Change in depression pre intervention to 1-month follow-up.	Depression will be assessed using the PROMIS - Depression Short Form 8b. The PROMIS - Depression is an 8-item self-report measure with possible scores ranging from 8 to 40. Higher scores indicate higher level of depression.	Baseline to 1-month follow-up
Secondary	Change in cognitive functioning pre intervention to 1-month follow-up.	Cognitive functioning will be assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). RBANS assesses cognitive functioning in the following domains: immediate memory, visuospatial functioning, attention, language, and delayed memory.	Baseline to 1-month follow-up
Secondary	Stability of anxiety sensitivity from posttreatment to 6-month follow-up.	Anxiety sensitivity will be measured using the Anxiety Sensitivity Index-3 (ASI-3). The ASI-3 is an 18-item self report measure with possible scores ranging from 0 to 72. Higher scores indicate higher anxiety sensitivity.	Immediately after the intervention to 6-month follow-up.
Secondary	Stability of anxiety from 1-month follow-up to 6-month follow-up.	Anxiety will be assessed using the Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS Anxiety) Short Form 8a self-report measure. The PROMIS Anxiety is an 8-item self report questionnaire with possible scores ranging from 8 to 40. Higher scores indicate more anxiety.	1-month to 6-month follow-up
Secondary	Stability of depression from 1-month follow-up to 6-month follow-up.	Depression will be assessed using the PROMIS - Depression Short Form 8b. The PROMIS - Depression is an 8-item self-report measure with possible scores ranging from 8 to 40. Higher scores indicate higher level of depression.	1-month to 6-month follow-up
Secondary	Stability of negative affect from 1-month follow-up to 6-month follow-up.	Negative affect will be assessed using the Positive and Negative Affect Schedule - Negative Affect (PANAS-NA). PANAS-NA is a 10-item self-report measure with possible scores ranging from 10 to 50. Higher scores indicate more negative affect.	1-month to 6-month follow-up
Secondary	Stability of stress from 1-month follow-up to 6-month follow-up.	Stress will be assessed with the NIH Toolbox - Perceived Stress. The NIH Toolbox - Perceived Stress is a 10-item self-report measure with possible scores ranging from 10 to 50. Higher scores indicate more stress.	1-month to 6-month follow-up
Secondary	Stability of quality of life from 1-month follow-up to 6-month follow-up.	Quality of life will be assessed with the NIH Toolbox General Life Satisfaction scale. The NIH Toolbox General Life Satisfaction scale is a 5-item self-report measure with possible scores ranging from 5 to 35. Higher scores indicate higher life satisfaction.	1-month to 6-month follow-up
Secondary	Stability of cognitive functioning from 1-month follow-up to 6-month follow-up.	Cognitive functioning will be assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). RBANS assesses cognitive functioning in the following domains: immediate memory, visuospatial functioning, attention, language, and delayed memory.	1-month to 6-month follow-up
Secondary	Change in care partner burden from pre intervention to 1-month follow-up.	Care partner burden will be assessed using the Zarit Burden Interview - Short. The Zarit Burden Interview - Short is a 12-item self-report questionnaire with a possible score range of 0 to 48. Higher scores indicate higher burden levels.	Baseline to 1-month follow-up
Secondary	Change in objective measure of interoceptive fear conditioning pre to posttreatment	Interoceptive fear conditioning will be assessed with a skin conductance response (SCR) during an interoceptive exposure. Higher SCR numbers indicate higher interoceptive fear.	Baseline to immediately after the intervention