Psychological StressPan-ACTNCT05433662
Pandemic Acceptance and Commitment Therapy (Pan-ACT): Telehealth Delivery With Older Veterans
An observational study of Psychological Stress, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Pandemic Acceptance and Commitment Therapy (Pan-ACT)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2022to 23 Jan 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Veteran
- receives care at Tuscaloosa VA Medical Center
- score of 9 or greater on the COVID-19 Mental Health Impacts Scale
- English speaking
- provides written informed consent
- age 60 or older
Who cannot join
- diagnosis of dementia
- score of 31 or less on the Modified Telephone Interview for Cognitive Status
- actively suicidal or homicidal
- actively psychotic
- unstable medical condition
- active substance use disorder
- currently participating in another cognitive behavioral therapy (CBT) intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, 35404-5015
About this study
Official title: Pandemic Acceptance and Commitment Therapy (Pan-ACT): Feasibility and Acceptability of Telehealth Delivery With Older Veterans
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.
Read the detailed description
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.
- Conditions
- Psychological Stress
- Being tested
- Pandemic Acceptance and Commitment Therapy (Pan-ACT)
- Keywords
- Older adult, acceptance and commitment therapy, telehealth, pandemic
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pandemic Acceptance and Commitment Therapy (Pan-ACT)Behavioural
Also called Acceptance and Commitment Therapy (ACT); ACT for Older Adults; The Third ACT
Pan-ACT is a 10-session, closed group, transdiagnostic intervention for older adults delivered by telehealth platform.
| Study group | Role | What they receive |
|---|---|---|
| Pandemic Acceptance and Commitment Therapy (Pan-ACT) | Open label assignment to Pan-ACT group telehealth intervention. Receives: Behavioral: Pandemic Acceptance and Commitment Therapy (Pan-ACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 14 weeks
Feasibility of Study Protocol - Telehealth Capability
Percent of participants enrolled (i.e., signed consent) who have telehealth capability for duration of intervention.
Measured: 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)
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start20 Dec 2022
- Primary completion31 Dec 2024
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Alabama, Tuscaloosa
- Responsible party
- Sponsor
- Investigators
- Lori L Davis, MD, Principal investigator, Tuscaloosa VA Medical Center, Tuscaloosa, AL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433662
- Sponsor's protocol ID
- D3898-P
- Other IDs
- 1I21RX003898-01A1
- Acronym
- Pan-ACT
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2022
- Last updated
- 22 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pandemic Acceptance and Commitment Therapy (Pan-ACT): Feasibility and Acceptability of Telehealth Delivery With Older Veterans
- ClinicalTrials.gov ID
- NCT05433662
- Acronym / sponsor ID
- Pan-ACT / D3898-P
- Conditions
- Psychological Stress
- Keywords
- Older adult, acceptance and commitment therapy, telehealth, pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Alabama, Tuscaloosa
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Posted 22 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pandemic Acceptance and Commitment Therapy (Pan-ACT) | – | Behavioral: Pandemic Acceptance and Commitment Therapy (Pan-ACT)Open label assignment to Pan-ACT group telehealth intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- Veteran
- receives care at Tuscaloosa VA Medical Center
- score of 9 or greater on the COVID-19 Mental Health Impacts Scale
- English speaking
- provides written informed consent
Key exclusion criteria (7 listed)
- diagnosis of dementia
- score of 31 or less on the Modified Telephone Interview for Cognitive Status
- actively suicidal or homicidal
- actively psychotic
- unstable medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pandemic Acceptance and Commitment Therapy (Pan-ACT)Also: Acceptance and Commitment Therapy (ACT); ACT for Older Adults; The Third ACTPan-ACT is a 10-session, closed group, transdiagnostic intervention for older adults delivered by telehealth platform. | Behavioural | Pandemic Acceptance and Commitment Therapy (Pan-ACT) |
Primary outcome
Acceptability of Study Protocol - Retention
Time frame: 14 weeks
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).
Feasibility of Study Protocol - Telehealth Capability
Time frame: 14 weeks
Percent of participants enrolled (i.e., signed consent) who have telehealth capability for duration of intervention.
Acceptability of Intervention - Group Attendance
Time frame: 14 weeks
Percent of participants who started the Pan-ACT intervention (denominator) and attended 70% or more of intervention sessions (numerator)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori L Davis, MD principal investigator
Tuscaloosa VA Medical Center, Tuscaloosa, AL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Stress, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Study Protocol - Retention (time frame: 14 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.