An observational study in Psychological Stress, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by VA Office of Research and Development · Observational
Older adults have been disproportionately impacted and distressed by the novel coronavirus (COVID-19) pandemic. Social distancing and stay-at-home orders have increased older adults' risk of social isolation and loneliness that will has led to a pandemic-induced fear of being in close proximity to other people. These fears and avoidant behaviors will have lasting effects if not treated with effective, safe, and convenient psychological interventions. This study will evaluate the acceptability and feasibility of delivering a small group intervention, called Acceptance and Commitment Therapy (ACT), through a telehealth modality to Veterans ages 60 and older who are experiencing pandemic-related emotional and physical distress. ACT helps decrease emotional suffering, improve well-being and promote positive behavior change by increasing one's psychological flexibility through the practice of mindfulness, acceptance, and values-based behaviors. The knowledge gained from this study will be used to better tailor the invention to meet the needs of older Veterans in an era of post-pandemic recovery.
Significance: Accounting for over 80% of COVID-19 related deaths in the United States, adults ages 60 and older have been disproportionately impacted by this pandemic more than any other age group. As a result, they may bear a heavy psychological burden in the months and years to come. Older adults have been labeled "vulnerable" to COVID-19 and strongly encouraged to adhere to "social distancing." This prevention measure is meant to mitigate the spread of the virus but has increased older adults' risk of social isolation and loneliness, which are two known correlates of increased morbidity and mortality in late life. Pandemic-related restrictions have decreased older adults' life-space mobility and negatively affected their physical and nutritional well-being, impairing their quality of life and potentially increasing their vulnerability to poorer outcomes if exposed to COVID-19. Research has documented a plethora of pandemic-related stressors that are common among older adults (e.g., fear of infection, loss of loved ones, financial repercussions) and the culminating psychological impact. Telehealth-adapted evidence-based psychological interventions are needed to address the psychosocial and physical toll of the pandemic among older Veterans. Acceptance and Commitment Therapy (ACT) decreases emotional suffering, improves well-being, promotes and supports healthy behavior changes, and treats a wide range of diagnoses by increasing psychological flexibility through mindfulness, acceptance, and values-based behaviors. Higher psychological flexibility has been associated with pandemic-related coping and well-being. Randomized studies of ACT with older adults are few but promising, and most research studies with this population have used a group format. While research on telehealth delivery of ACT for older adults is limited, preliminary results indicate it is feasible and as effective as ACT delivered in person.
Specific Aim: The proposed study will pilot a 10-session telehealth Pandemic ACT group intervention (i.e., Pan-ACT group) with Veterans ages 60 and older who are experiencing pandemic-related emotional and physical distress.
Methods and Procedures: Twenty-five older Veterans will be enrolled in this single-arm feasibility pilot trial. The intervention will be delivered weekly in 90-minute sessions of groups of four to five Veterans. Feasibility and acceptability of study procedures will be measured by referred-to-enrolled rate, telehealth access and capability, electronic data collection of outcome measures, and qualitative feedback on data collection procedures and measures. Feasibility and acceptability of the intervention will be measured by attendance; attrition; homework completion; participant ratings of the intervention's feasibility, acceptability, and fit; qualitative feedback; and treatment fidelity. Preliminary responsiveness of outcomes measures will be explored. Participants will complete measures of pandemic-related emotional and physical distress, psychological flexibility, depression, anxiety, social connectedness, perceived health, functional impairment, and meaningful engagement at baseline, posttreatment, and one-month follow-up. A brief midpoint assessment at week 5 of the group will consist of measures of social connectedness and functional impairment. Qualitative data will be gathered on perceived efficacy to implement intervention skills and specific emotional or behavioral changes participants have noticed in themselves as a result of the intervention.
Conclusion: The telehealth Pan-ACT Group is a mental and behavioral health rehabilitation intervention that focuses on helping older Veterans develop or recover coping skills that were lost or are no longer effective during the ongoing COVID-19 pandemic. The proposed study address a major research and clinical gap by gathering new knowledge for an urgent need, which will inform the development of a full-scale randomized controlled trial to evaluate the intervention's effectiveness.
783 studies on the registry are indexed under Stress, Psychological; 128 are open to participants now.
This study's enrollment of 24 is below the median of 174 across 139 observational studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
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Veterans ages 60 and older receiving services at the Tuscaloosa VA Medical Center (TVAMC) were recruited from primary care, home-based primary care, and mental health clinics.
Exclusion Criteria:
Open label assignment to Pan-ACT group telehealth intervention.
Behavioral: Pandemic Acceptance and Commitment Therapy (Pan-ACT)
Pan-ACT is a 10-session, closed group, transdiagnostic intervention for older adults delivered by telehealth platform.
Also known as: Acceptance and Commitment Therapy (ACT); ACT for Older Adults; The Third ACT
Acceptability of Study Protocol - Retention
Retention is defined as number of participants who completed the post-treatment endpoint assessment (numerator) divided by the number of participants who signed informed consent (enrolled; denominator).
Time frame: 14 weeks
Feasibility of Study Protocol - Telehealth Capability
Percent of participants enrolled (i.e., signed consent) who have telehealth capability for duration of intervention.
Time frame: 14 weeks
Acceptability of Intervention - Group Attendance
Percent of participants who started the Pan-ACT intervention (denominator) and attended 70% or more of intervention sessions (numerator)
Time frame: 14 weeks
Acceptability of Study Protocol - Enrollment
The percent of individuals who were referred and pre-screened for the study (denominator) and subsequently enrolled (singed consent) in the study.
Time frame: 14 weeks
Acceptability of Study Protocol - Assessment Completion
The percent of participants who began the Pan-ACT intervention (denominator) and subsequently completed all study assessments (numerator).
Time frame: 14 weeks
Feasibility of Study Protocol - Timeline
Number of Pan-ACT intervention group cohorts that started as scheduled on timeline (numerator) divided by the total number of Pan-ACT intervention group cohorts.
Time frame: Through study completion (approximately 2 years) last session at year 2 reported.
Feasibility of Intervention - Treatment Fidelity
The Acceptance and Commitment Therapy Fidelity Measure (ACT-FM) is a 25-item scale used by an independent fidelity reviewer to score the four domains of the Pan-ACT intervention that were delivered by the therapist during the Pan-ACT group sessions. Each item is rated on a 4-point Likert scale ranging from 0 ("this behavior never occurred") to 3 ("therapist consistently enacts this behavior"). The total ACT consistency score and total ACT inconsistency score were calculated by adding the scores for the four domains. ACT-FM score can range from 0 to 36. Higher scores indicate greater fidelity to the Pan-ACT intervention model. The study's target was to reach at least 26 points on average for the fidelity reviews.
Time frame: Through study completion (approximately 2 years) last session at year 2 reported.
Participants were recruited from the Tuscaloosa VA Medical Center located in Tuscaloosa, Alabama (AL). Participants were enrolled between December 20, 2022, and May 22, 2024.
| Milestone | Pandemic Acceptance and Commitment Therapy (Pan-ACT) |
|---|---|
| Started | 24 |
| Began pan-act group | 15 |
| Completed | 15 |
| Not completed | 9 |
| Withdrew: Withdrawal by subject | 8 |
| Withdrew: Lost to follow-up | 1 |
Retention is defined as number of participants who completed the post-treatment endpoint assessment (numerator) divided by the number of participants who signed informed consent (enrolled; denominator).
| Participants | Pandemic Acceptance and Commitment Therapy (Pan-ACT) |
|---|---|
| Acceptability of Study Protocol - Retention | 15 |
Percent of participants enrolled (i.e., signed consent) who have telehealth capability for duration of intervention.
| Participants | Pandemic Acceptance and Commitment Therapy (Pan-ACT) |
|---|---|
| Feasibility of Study Protocol - Telehealth Capability | 12 |
Percent of participants who started the Pan-ACT intervention (denominator) and attended 70% or more of intervention sessions (numerator)
| Participants | Pandemic Acceptance and Commitment Therapy (Pan-ACT) |
|---|---|
| Acceptability of Intervention - Group Attendance | 10 |
The percent of individuals who were referred and pre-screened for the study (denominator) and subsequently enrolled (singed consent) in the study.
| Participants | Pandemic Acceptance and Commitment Therapy (Pan-ACT) |
|---|---|
| Acceptability of Study Protocol - Enrollment | 24 |
The percent of participants who began the Pan-ACT intervention (denominator) and subsequently completed all study assessments (numerator).
| Participants | Pandemic Acceptance and Commitment Therapy (Pan-ACT) |
|---|---|
| Acceptability of Study Protocol - Assessment Completion | 13 |
Number of Pan-ACT intervention group cohorts that started as scheduled on timeline (numerator) divided by the total number of Pan-ACT intervention group cohorts.
| Group Cohorts | Pandemic Acceptance and Commitment Therapy (Pan-ACT) |
|---|---|
| Feasibility of Study Protocol - Timeline | 3 |
The Acceptance and Commitment Therapy Fidelity Measure (ACT-FM) is a 25-item scale used by an independent fidelity reviewer to score the four domains of the Pan-ACT intervention that were delivered by the therapist during the Pan-ACT group sessions. Each item is rated on a 4-point Likert scale ranging from 0 ("this behavior never occurred") to 3 ("therapist consistently enacts this behavior"). The total ACT consistency score and total ACT inconsistency score were calculated by adding the scores for the four domains. ACT-FM score can range from 0 to 36. Higher scores indicate greater fidelity to the Pan-ACT intervention model. The study's target was to reach at least 26 points on average for the fidelity reviews.
| score on a scale | Pandemic Acceptance and Commitment Therapy (Pan-ACT) |
|---|---|
| Feasibility of Intervention - Treatment Fidelity | 34.7 ± 1.8 |
Collected over Adverse Events were collected on participants who attended at least one Pan-ACT group (n=15) during their time in the study lasting up to 14 weeks. Adverse event data were collected over the 2-year study timeframe.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pandemic Acceptance and Commitment Therapy (Pan-ACT) | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
Signed Informed Consent
| Age, Continuous(years) | Pandemic Acceptance and Commitment Therapy (Pan-ACT) |
|---|---|
| Mean | 67.29 ± 3.56 |
| Sex: Female, Male(Participants) | Pandemic Acceptance and Commitment Therapy (Pan-ACT) |
|---|---|
| Female | 2 |
| Male | 22 |
| Race/Ethnicity, Customized(Participants) | Pandemic Acceptance and Commitment Therapy (Pan-ACT) |
|---|---|
| Black | 17 |
| White | 7 |
| Region of Enrollment(Participants) | Pandemic Acceptance and Commitment Therapy (Pan-ACT) |
|---|---|
| United States | 24 |
| COVID-19 Mental Health Impacts Scale(units on a scale) | Pandemic Acceptance and Commitment Therapy (Pan-ACT) |
|---|---|
| Mean | 11.8 ± 3.76 |
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