Anxiety Sensitivity Treatment to Reduce Anxiety in Alzheimer's

Official title

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

Overview

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.

Detailed 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.

Interventions

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

Primary outcome measures

• 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]

Secondary outcome measures (12)

• Change in negative affect pre intervention to 1-month follow-up. [Time frame: Baseline to 1-month follow-up]
• Change in stress pre intervention to 1-month follow-up. [Time frame: Baseline to 1-month follow-up]
• Change in quality of life pre intervention to 1-month follow-up. [Time frame: Baseline to 1-month follow-up]
• Change in depression pre intervention to 1-month follow-up. [Time frame: Baseline to 1-month follow-up]
• Change in cognitive functioning pre intervention to 1-month follow-up. [Time frame: Baseline to 1-month follow-up]
• Stability of anxiety sensitivity from posttreatment to 6-month follow-up. [Time frame: Immediately after the intervention to 6-month follow-up.]
• Stability of anxiety from 1-month follow-up to 6-month follow-up. [Time frame: 1-month to 6-month follow-up]
• Stability of depression from 1-month follow-up to 6-month follow-up. [Time frame: 1-month to 6-month follow-up]
• Stability of negative affect from 1-month follow-up to 6-month follow-up. [Time frame: 1-month to 6-month follow-up]
• Stability of stress from 1-month follow-up to 6-month follow-up. [Time frame: 1-month to 6-month follow-up]
• Stability of quality of life from 1-month follow-up to 6-month follow-up. [Time frame: 1-month to 6-month follow-up]
• Stability of cognitive functioning from 1-month follow-up to 6-month follow-up. [Time frame: 1-month to 6-month follow-up]

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

• Participant MoCA score is between 17 to 26

OR

• Participant Memory Complaint Scale score 3 or greater

OR

• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 3 centers

• Anxiety and Behavioral Health Clinic — Tallahassee
• Ohio University — Athens
• The Ohio State University — Columbus

Publications

• 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. PMID 30199696
• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. PMID 15817019
• Vale FAC, Balieiro AP Jr, Silva-Filho JH. Memory complaint scale (MCS). Proposed tool for active systematic search. Dement Neuropsychol. 2012 Oct-Dec;6(4):212-218. doi: 10.1590/S1980-57642012DN06040004. PMID 29213800
• Galvin JE. THE QUICK DEMENTIA RATING SYSTEM (QDRS): A RAPID DEMENTIA STAGING TOOL. Alzheimers Dement (Amst). 2015 Jun 1;1(2):249-259. doi: 10.1016/j.dadm.2015.03.003. PMID 26140284
• Randolph C, Tierney MC, Mohr E, Chase TN. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 1998 Jun;20(3):310-9. doi: 10.1076/jcen.20.3.310.823. PMID 9845158
• Delis, D. C., Kaplan, E., & Kramer, J. H. (2001). Delis-Kaplan Executive Function System (D-KEFS) [Database record]. APA PsycTests.
• Wechsler, D. (2008). Wechsler Adult Intelligence Scale--Fourth Edition (WAIS-IV) [Database record]. APA PsycTests.
• Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57. PMID 9881538

Identifiers

NCT: NCT05748613 · STUDY00003432

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗