AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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)
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

Other trials in United States

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.

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 groups in NCT05433662
Study groupRoleWhat 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.

  1. 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

  2. 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

  3. 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.

  1. First posted27 Jun 2022
  2. Study start20 Dec 2022
  3. Primary completion31 Dec 2024
  4. Study completion23 Jan 2025

Resources

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)
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
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in