Computerized Anxiety Treatment for Mild Alzheimer's Disease

(ASTRA Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Florida State University

Disqualifiers: Severe mental illness, others

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Computerized Anxiety Sensitivity Treatment (CAST) for anxiety in patients with mild Alzheimer's disease?

Research shows that brief interventions targeting anxiety sensitivity can significantly reduce anxiety in older adults with mild cognitive impairment, which is related to Alzheimer's. Additionally, computerized cognitive training has been found to improve mood and anxiety in similar populations.

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Is the computerized anxiety treatment safe for humans?

The computerized anxiety treatment has been tested in various studies and appears to be safe for humans, as it has been used to reduce anxiety sensitivity in different groups, including veterans and university students, without reported safety concerns.

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How is the Computerized Anxiety Sensitivity Treatment (CAST) different from other treatments for anxiety in mild Alzheimer's disease?

CAST is unique because it uses a computerized approach to specifically target anxiety sensitivity, which is a risk factor for anxiety, through brief interventions. This method is different from traditional treatments as it focuses on reducing anxiety sensitivity using technology, potentially making it more accessible and tailored for individuals with mild Alzheimer's disease.

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Eligibility Criteria

This trial is for pairs of older adults (60+) with mild cognitive impairment or early Alzheimer's and their care partners (18+). Participants must have a certain level of anxiety, be able to use a smartphone or Wi-Fi, and not suffer from severe mental illness or medical conditions that would interfere with the study. Care partners should provide support and help with decision-making.

Inclusion Criteria

DYAD: Has smartphone or access to Wi-Fi

OR: Participant Memory Complaint Scale score 3 or greater

My care partner is 18 years old or older.

Exclusion Criteria

CARE PARTNER: Issues with seeing or hearing that would prevent reading or listening to computer presentations

PATIENT: Issues with seeing or hearing that would prevent reading or listening to computer presentations

PATIENT: Severe mental illness (e.g., schizophrenia, unmedicated bipolar disorder)

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessment includes a neuropsychological evaluation, baseline questionnaires, and introduction to the EMA application

1 week

1 visit (in-person)

Intervention

Participants undergo two intervention sessions with either CAST or HEC, including interoceptive exposures or behavior tracking and goal-setting

3 weeks

2 visits (in-person)

Ecological Momentary Assessments (EMA)

Participants complete daily EMAs about emotional and other factors using an application

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up cognitive testing and outcome questionnaires

6 months

3 visits (in-person) at 1, 3, and 6 months

Participant Groups

The trial tests if computerized anxiety sensitivity treatment (CAST) is more effective than health education control (HEC) in reducing anxiety symptoms in patients and easing the burden on their care partners. It includes baseline assessments, intervention sessions, follow-ups at 1, 3, and 6 months post-treatment, plus weekly ecological momentary assessments.

Group I: Computerized Anxiety Sensitivity Treatment Experimental Treatment 1 Intervention

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.

Group II: Health Education Control Placebo Group 1 Intervention

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).

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Ohio University Athens, OH

The Ohio State University Columbus, OH

Anxiety and Behavioral Health Clinic Tallahassee, FL

Who Is Running the Clinical Trial?

Florida State University Lead Sponsor

Ohio University Collaborator

Ohio State University Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Brief, interoceptive exposure focused treatment for anxiety in mild cognitive impairment. [2022] Anxiety is common in older adults with mild cognitive impairment (MCI), and Alzheimer's disease and related dementias (ADRD). Anxiety has also been identified as a risk factor for cognitive decline. Brief interventions targeting risk mechanisms of anxiety, such as anxiety sensitivity (AS), have been effective in reducing overall anxiety in a variety of populations. This case series investigated the feasibility and efficacy of a brief AS intervention in anxious older adults with MCI (n = 9). Paired samples t-test results indicate that this intervention is capable of significantly reducing AS as measured by the Anxiety Sensitivity Index-3 (Δ = 5.11, Hedges g = 0.82, P

2. England pubmed.ncbi.nlm.nih.gov

A single-blind, parallel-group randomised trial of a Technology-assisted and remotely delivered Cognitive Behavioural Therapy intervention (Tech-CBT) versus usual care to reduce anxiety in people with mild cognitive impairment and dementia: study protocol for a randomised trial. [2023] Anxiety is commonly experienced by people living with mild cognitive impairment (MCI) and dementia. Whilst there is strong evidence for late-life anxiety treatment using cognitive behavioural therapy (CBT) and delivery via telehealth, there is little evidence for the remote delivery of psychological treatment for anxiety in people living with MCI and dementia. This paper reports the protocol for the Tech-CBT study which aims to investigate the efficacy, cost-effectiveness, usability and acceptability of a technology-assisted and remotely delivered CBT intervention to enhance delivery of anxiety treatment for people living with MCI and dementia of any aetiology.

3. United States pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis. [2022] Previous meta-analyses indicate that computerized cognitive training (CCT) is a safe and efficacious intervention for cognition in older adults. However, efficacy varies across populations and cognitive domains, and little is known about the efficacy of CCT in people with mild cognitive impairment or dementia.

4. Netherlands pubmed.ncbi.nlm.nih.gov

Prevalence of anxiety in patients with mild cognitive impairment: A systematic review and meta-analysis. [2019] Prevalence rates of anxiety in patients with mild cognitive impairment (MCI) varied widely across studies and may confer a higher likelihood of progression to dementia. Our aim was to estimate the prevalence of anxiety in MCI and identify reasons for heterogeneity in the reported results.

5. United States pubmed.ncbi.nlm.nih.gov

Doctor, Should I Use Computer Games to Prevent Dementia? [2020] Commercial advertising of computerized "brain games" may result in clinicians being asked whether brain games prevent dementia. To address this question, we conducted a review of computerized cognitive training (CCT) interventions in older adults with Mild Cognitive Impairment (MCI). Studies were identified using a PubMed and PSYCinfo search for review articles. Within 11 review articles we identified 15 unique studies. Nine of these studies used commercially available "brain games" as their primary CCT intervention. Nine of 12 studies that examined the effect of CCT on episodic memory performance showed significant improvements in this domain. Furthermore, four of six studies that examined mood and or anxiety showed improvements in these domains following a CCT intervention. While more than double the amount of time was spent on the training that used commercially available "brain games" versus those designed by investigators, there were no differences in outcomes. Overall, it appears that "brain games" may modestly benefit aspects of cognition and aspects of mood in patients presenting with MCI. However, there is no direct evidence from the studies presented here that "brain games"/CCT can prevent dementia. We present recommendations to consider when discussing "brain games" with persons with MCI.

6. United States pubmed.ncbi.nlm.nih.gov

Acceptability of cognitive anxiety sensitivity treatment among veterans with mTBI. [2023] Anxiety sensitivity (AS) is a transdiagnostic risk factor for persistent physical and psychological symptoms relevant to veterans, such as postconcussive symptoms following mild traumatic brain injury (mTBI). The Cognitive Anxiety Sensitivity Treatment (CAST) computerized intervention has been shown to reduce AS but has not been widely used among veterans. The purpose of this study was to assess the acceptability and feasibility of CAST among veterans with elevated AS and mTBI eligible to receive Veterans Health Administration (VHA) care.

7. Netherlands pubmed.ncbi.nlm.nih.gov

Is computerized psychoeducation sufficient to reduce anxiety sensitivity in an at-risk sample?: A randomized trial. [2019] Anxiety sensitivity (AS), or a fear of anxiety-related sensations, has become one of the most well researched risk factors for the development of psychopathology and comprises three subfactors: physical, cognitive, and social concerns. Fortunately, research has demonstrated brief protocols can successfully reduce AS, and in turn improve psychopathological symptoms. Computerized AS reduction protocols have combined psychoeducation with interoceptive exposure (IE), but they have not been dismantled to evaluate the effects of psychoeducation alone.

8. England pubmed.ncbi.nlm.nih.gov

Development and randomized trial evaluation of a novel computer-delivered anxiety sensitivity intervention. [2018] Anxiety disorders contribute substantially to the overall public health burden of psychopathology. Anxiety sensitivity (AS), a fear of anxiety related sensations, is one of the few known malleable risk factors for anxiety pathology. Previous AS reduction treatments have utilized highly trained clinicians. A completely-computerized AS treatment would reduce costs and increase dissemination possibilities. Cognitive bias modification for interpretation biases (CBM-I) interventions have shown clinically significant reductions in anxiety symptoms. Another emerging literature focused on learning has shown context-shifting tasks can greatly increase learning without adding logistical burden to an intervention. The current study evaluated a CBM-I for AS that utilized a context-shifting task to deliver twice the treatment dose of extant interventions.

9. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized controlled trial evaluating the efficacy of a brief computerized anxiety sensitivity reduction intervention for health anxiety. [2021] It is estimated that individuals with severe health anxiety (HA) utilize 41 %-78 % more healthcare resources than individuals with identified medical diagnoses. Thus, identifying targets for intervention and prevention efforts for HA that are appropriate for primary care or specialty clinic settings is imperative. The aim of the present investigation was to evaluate the effect of a single-session, computerized anxiety sensitivity (AS) intervention on AS and HA. Participants were 68 university students (79.4 % female; Mage = 19.68) with elevated levels of AS and HA. Participants were randomized to either the AS intervention condition or an active control condition and completed self-report and behavioral follow-up assessments at post-intervention, 1-week follow-up, and 1-month follow-up. Results indicated a significant Time x Condition interaction for ASI-3 at each follow-up assessment (all ps < .001), such that individuals in the active condition exhibited greater reductions in AS compared to the control condition. There was no significant Time x Condition interaction for HA at any follow-up. Mediation analyses revealed a significant indirect effect of Condition on changes in HA through changes in AS. No significant effects were observed for behavioral outcomes. Findings suggest that this intervention successfully reduces AS among those who are high in HA and AS and may indirectly contribute to reductions in HA over time through reductions in AS.

10. Switzerland pubmed.ncbi.nlm.nih.gov

An Intervention on Anxiety Symptoms in Moderate Alzheimer's Disease through Virtual Reality: A Feasibility Study and Lessons Learned. [2023] (1) Background: Although cognitive impairment is considered the core deficit of dementia, anxiety disorders also have a negative influence on the social and daily life of the affected population. We have explored the exposure of relaxing scenarios in immersive Virtual Reality (iVR) as an intervention strategy for people with moderate Alzheimer's disease. (2) Methods: Three participants were recruited from a day center to participate in a five-week study, which included a Pre- and Post-evaluation with the Montreal Cognitive Assessment (MoCA), Neuropsychiatric Inventory-Questionnaire (NPI-Q), Clinical Dementia Rating Scale (CDR), Global Deterioration Scale (GDS), Hamilton Anxiety Rating Scale (HARS), State-Trait Anxiety Inventory (STAI), and the anxiety subdomain of the Neuropsychiatric Inventory (NPI). Participants' heart rate, oxygen saturation, arterial pressure, and respiratory rate were also monitored during intervention sessions. Three virtual scenarios from Nature Treks VR were used as the intervention over three weeks (a total of nine sessions). (3) Results: Post-intervention anxiety assessment showed a light reduction in psychological anxiety in the HARS questionnaire. A light reduction in heart rate was also observed during the exposure to iVR. (4) Discussion: The use of virtual scenarios was a satisfactory experience for all the participants. Preliminary data point to a relaxing effect of iVR scenarios and a potential reduction in psychological anxiety, but further research is required to confirm the efficacy of the intervention.

11. United States pubmed.ncbi.nlm.nih.gov

Persons with moderate Alzheimer's disease use simple technology aids to manage daily activities and leisure occupation. [2014] Two studies assessed technology-aided programs to support performance of daily activities and selection/activation of music items with patients with moderate Alzheimer's disease. In Study I, four patients were presented with activity-related pictorial instructions via a computer fitted with inexpensive, commercial software. In Study II, four patients were (a) presented with different music options and (b) allowed to select and activate the preferred option via a microswitch response. Study I showed that each patient learned to perform the two activities available with percentages of correct responses exceeding 85 by the end of the intervention. Study II showed that all patients learned to choose and activate music options. Psychology students, employed in a social validation check, scored the patients' behavior within the program better than their behavior in a control situation. The relevance and usability of simplified pictorial-instruction programs and music choice programs for patients with moderate Alzheimer's disease were discussed.