Clinical trial NCT05748613: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Mild Cognitive Impairment
Alzheimer Disease
Dementia
Keywords: Computerized Intervention
Brief Treatment
Psychoeducation
Interoceptive Exposure
Older Adults
Care Partner
Anxiety Sensitivity
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Ohio State University
name: Ohio University
First posted: 2023-03-01
Enrollment: 388
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Variable-sized permuted block randomization will be used to allocate participants to treatment condition, stratified by dementia severity (MCI vs. mild ADRD) and gender.
Primary purpose: TREATMENT

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.

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.

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)

Primary outcomes:
measure: Change in anxiety sensitivity pre intervention to posttreatment.
timeFrame: Baseline to immediately after the intervention
measure: Change in anxiety pre intervention to 1-month follow-up.
timeFrame: Baseline to 1-month follow-up
Secondary outcomes:
measure: Change in negative affect pre intervention to 1-month follow-up.
timeFrame: Baseline to 1-month follow-up
measure: Change in stress pre intervention to 1-month follow-up.
timeFrame: Baseline to 1-month follow-up
measure: Change in quality of life pre intervention to 1-month follow-up.
timeFrame: Baseline to 1-month follow-up
measure: Change in depression pre intervention to 1-month follow-up.
timeFrame: Baseline to 1-month follow-up
measure: Change in cognitive functioning pre intervention to 1-month follow-up.
timeFrame: Baseline to 1-month follow-up
measure: Stability of anxiety sensitivity from posttreatment to 6-month follow-up.
timeFrame: Immediately after the intervention to 6-month follow-up.
measure: Stability of anxiety from 1-month follow-up to 6-month follow-up.
timeFrame: 1-month to 6-month follow-up
measure: Stability of depression from 1-month follow-up to 6-month follow-up.
timeFrame: 1-month to 6-month follow-up
measure: Stability of negative affect from 1-month follow-up to 6-month follow-up.
timeFrame: 1-month to 6-month follow-up
measure: Stability of stress from 1-month follow-up to 6-month follow-up.
timeFrame: 1-month to 6-month follow-up
measure: Stability of quality of life from 1-month follow-up to 6-month follow-up.
timeFrame: 1-month to 6-month follow-up
measure: Stability of cognitive functioning from 1-month follow-up to 6-month follow-up.
timeFrame: 1-month to 6-month follow-up
measure: Change in care partner burden from pre intervention to 1-month follow-up.
timeFrame: Baseline to 1-month follow-up
measure: Change in objective measure of interoceptive fear conditioning pre to posttreatment
timeFrame: Baseline to immediately after the intervention
measure: Change in Loneliness from pre intervention to 1-month follow up
timeFrame: Baseline through Month 1 follow up
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Anxiety and Behavioral Health Clinic
state: Florida
city: Athens
country: United States
facility: Ohio University
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Delis, D. C., Kaplan, E., & Kramer, J. H. (2001). Delis-Kaplan Executive Function System (D-KEFS) [Database record]. APA PsycTests.
citation: Wechsler, D. (2008). Wechsler Adult Intelligence Scale--Fourth Edition (WAIS-IV) [Database record]. APA PsycTests.
citation: 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.
citation: Taylor S, Zvolensky MJ, Cox BJ, Deacon B, Heimberg RG, Ledley DR, Abramowitz JS, Holaway RM, Sandin B, Stewart SH, Coles M, Eng W, Daly ES, Arrindell WA, Bouvard M, Cardenas SJ. Robust dimensions of anxiety sensitivity: development and initial validation of the Anxiety Sensitivity Index-3. Psychol Assess. 2007 Jun;19(2):176-88. doi: 10.1037/1040-3590.19.2.176.
citation: Kupst MJ, Butt Z, Stoney CM, Griffith JW, Salsman JM, Folkman S, Cella D. Assessment of stress and self-efficacy for the NIH Toolbox for Neurological and Behavioral Function. Anxiety Stress Coping. 2015;28(5):531-44. doi: 10.1080/10615806.2014.994204. Epub 2015 Feb 10.
citation: Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
citation: Craig, C., Marshall, A., Sjostrom, M., Bauman, A., Lee, P., Macfarlane, D., ... & Stewart, S. (2017). International physical activity questionnaire-short form. J Am Coll Health, 65(7), 492-501.
citation: Zarit, S., Orr, N. K., & Zarit, J. M. (1985). The hidden victims of Alzheimer's disease: Families under stress. NYU press.
citation: Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.
citation: Hughes CP, Berg L, Danziger WL, Coben LA, Martin RL. A new clinical scale for the staging of dementia. Br J Psychiatry. 1982 Jun;140:566-72. doi: 10.1192/bjp.140.6.566.
citation: Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
citation: Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
citation: Hatcher, R. L., & Gillaspy, A. (2006). Working Alliance Inventory-Short Revised [Database record]. APA PsycTests.