Computerized Anxiety Treatment for Mild Alzheimer's Disease

(ASTRA Trial)

Recruiting at 2 trial locations

Overseen By Frederick T Schubert, B.A.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Severe mental illness, others

Compensation: Varies

Number of Visits: 6

388 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{1 2 5 10 11}

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)

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

Treatment Details

Interventions

• Computerized Anxiety Sensitivity Treatment
• Health Education Control

Trial Overview 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.

Participant Groups

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).

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Ohio University

Collaborator

Trials

73

Recruited

17,800+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Findings from Research

A brief intervention targeting anxiety sensitivity was found to significantly reduce anxiety sensitivity in older adults with mild cognitive impairment (MCI), based on a study involving 9 participants.

The intervention showed a large effect size (Hedges g = 0.82) and was well-accepted, suggesting it could be a promising approach for managing anxiety in this population, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief, interoceptive exposure focused treatment for anxiety in mild cognitive impairment. Schmidt, NB., Schubert, FT., Sheffler, JL.[2022]

The Tech-CBT study is the first trial to assess a technology-assisted cognitive behavioral therapy (CBT) intervention for reducing anxiety in individuals with mild cognitive impairment (MCI) and dementia, involving 70 participants split between the intervention and usual care groups.

The study aims to evaluate not only the efficacy of the Tech-CBT intervention in reducing anxiety but also its cost-effectiveness and acceptability, potentially improving access to psychological treatment for this population.

NCBI (Pubmed)

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. Dissanayaka, N., Brooks, D., Worthy, P., et al.[2023]

Computerized cognitive training (CCT) shows moderate efficacy in improving overall cognition and specific cognitive domains in older adults with mild cognitive impairment, based on a review of 17 trials.

In individuals with dementia, CCT has limited evidence of efficacy, primarily influenced by a few trials using immersive technologies like virtual reality, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis. Hill, NT., Mowszowski, L., Naismith, SL., et al.[2022]

The overall prevalence of anxiety in patients with mild cognitive impairment (MCI) was found to be 21.0%, based on a systematic review of 39 studies involving 10,587 patients, indicating that anxiety is a common issue in this population.

The prevalence of anxiety varied significantly depending on the source of the sample, with community-based samples showing 14.3% prevalence and clinic-based samples showing 31.2%, highlighting the importance of sample context in understanding anxiety rates in MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of anxiety in patients with mild cognitive impairment: A systematic review and meta-analysis. Chen, C., Hu, Z., Jiang, Z., et al.[2019]

Computerized cognitive training (CCT), including commercially available 'brain games', may lead to modest improvements in cognitive functions like episodic memory and mood in older adults with Mild Cognitive Impairment (MCI), based on a review of 15 studies.

Despite these improvements, there is no evidence that 'brain games' can prevent dementia, highlighting the need for caution when discussing their effectiveness with patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doctor, Should I Use Computer Games to Prevent Dementia? O'Shea, DM., De Wit, L., Smith, GE.[2020]

The Cognitive Anxiety Sensitivity Treatment (CAST) intervention was found to be acceptable to 77.3% of the 22 veterans with mild traumatic brain injury (mTBI) and elevated anxiety sensitivity, indicating potential for use in this population.

While CAST showed effectiveness in reducing anxiety sensitivity among participants, technological issues like internet connectivity limited the feasibility of consistently delivering the intervention, suggesting a need for improved access in future implementations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of cognitive anxiety sensitivity treatment among veterans with mTBI. Betthauser, LM., Albanese, BJ., Cochran, KL., et al.[2023]

A brief single-session psychoeducation intervention significantly reduced anxiety sensitivity (AS) and fear reactivity in at-risk individuals, as shown in a study with 54 participants.

The reduction in fear reactivity was linked to decreased cognitive concerns about anxiety, indicating that psychoeducation can effectively address specific aspects of anxiety sensitivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is computerized psychoeducation sufficient to reduce anxiety sensitivity in an at-risk sample?: A randomized trial. Norr, AM., Gibby, BA., Schmidt, NB.[2019]

A single-session, computer-delivered cognitive bias modification for interpretation biases (CBM-I) significantly reduced anxiety sensitivity (AS) by 62% immediately after the intervention, with a 64% reduction maintained one month later.

Participants in the active treatment group experienced fewer panic responses during a physiological challenge, indicating that the intervention not only reduced AS but also improved coping mechanisms related to anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and randomized trial evaluation of a novel computer-delivered anxiety sensitivity intervention. Capron, DW., Schmidt, NB.[2018]

A single-session computerized intervention targeting anxiety sensitivity (AS) significantly reduced AS in 68 university students with high health anxiety (HA), with effects lasting up to one month after the intervention.

While the intervention did not directly reduce health anxiety, it indirectly contributed to lower HA levels over time by first decreasing anxiety sensitivity, suggesting a potential pathway for future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial evaluating the efficacy of a brief computerized anxiety sensitivity reduction intervention for health anxiety. O'Bryan, EM., McLeish, AC., Norr, AM., et al.[2021]

In a five-week study involving three participants with moderate Alzheimer's disease, immersive Virtual Reality (iVR) scenarios showed a slight reduction in psychological anxiety as measured by the Hamilton Anxiety Rating Scale (HARS).

Participants also experienced a light reduction in heart rate during iVR sessions, suggesting a potential relaxing effect, although further research is needed to confirm the overall efficacy of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Intervention on Anxiety Symptoms in Moderate Alzheimer's Disease through Virtual Reality: A Feasibility Study and Lessons Learned. Sánchez-Nieto, D., Castaño-Castaño, S., Navarro-Martos, R., et al.[2023]

In two studies involving eight patients with moderate Alzheimer's disease, technology-aided programs using pictorial instructions and music selection significantly improved the patients' ability to perform daily activities and engage with music, with over 85% correct responses in activity tasks.

Patients demonstrated effective learning in both studies, as evidenced by psychology students rating their behavior during the program more positively than in control situations, highlighting the potential of these interventions for enhancing daily functioning in Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persons with moderate Alzheimer's disease use simple technology aids to manage daily activities and leisure occupation. Lancioni, GE., Singh, NN., O'Reilly, MF., et al.[2014]

References

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

Brief, interoceptive exposure focused treatment for anxiety in mild cognitive impairment. [2022]

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]

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]

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

Prevalence of anxiety in patients with mild cognitive impairment: A systematic review and meta-analysis. [2019]

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

Doctor, Should I Use Computer Games to Prevent Dementia? [2020]

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

Acceptability of cognitive anxiety sensitivity treatment among veterans with mTBI. [2023]

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

Is computerized psychoeducation sufficient to reduce anxiety sensitivity in an at-risk sample?: A randomized trial. [2019]

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

Development and randomized trial evaluation of a novel computer-delivered anxiety sensitivity intervention. [2018]

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]

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]

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]