NCT05433662

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

December 20, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2025

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 22, 2026

Completed
Last Updated

July 22, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

June 21, 2022

Results QC Date

December 11, 2025

Last Update Submit

June 23, 2026

Conditions

Keywords

Older adultacceptance and commitment therapytelehealthpandemic

Outcome Measures

Primary Outcomes (3)

  • 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).

    14 weeks

  • Feasibility of Study Protocol - Telehealth Capability

    Percent of participants enrolled (i.e., signed consent) who have telehealth capability for duration of intervention.

    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)

    14 weeks

Other Outcomes (4)

  • Acceptability of Study Protocol - Enrollment

    14 weeks

  • Acceptability of Study Protocol - Assessment Completion

    14 weeks

  • Feasibility of Study Protocol - Timeline

    Through study completion (approximately 2 years) last session at year 2 reported.

  • +1 more other outcomes

Study Arms (1)

Pandemic Acceptance and Commitment Therapy (Pan-ACT)

Open label assignment to Pan-ACT group telehealth intervention.

Behavioral: Pandemic Acceptance and Commitment Therapy (Pan-ACT)

Interventions

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
Pandemic Acceptance and Commitment Therapy (Pan-ACT)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Tuscaloosa, Alabama, 35404-5015, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Aging

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Limitations and Caveats

The study enrollment was negatively impacted by the timing of the study launch, i.e. study recruitment started in 2022 after the COVID-19 pandemic social restrictions had been lifted and pandemic-related fears had been reduced once a COVID-19 vaccine was universally available. This resulted in a small sample size which is a limitation of the trial. Homework adherence could not be collected, so is no longer included as an outcome of the study.

Results Point of Contact

Title
M. Lindsey Jacobs, PhD
Organization
University of Alabama

Study Officials

  • Lori L Davis, MD

    Tuscaloosa VA Medical Center, Tuscaloosa, AL

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 27, 2022

Study Start

December 20, 2022

Primary Completion

December 31, 2024

Study Completion

January 23, 2025

Last Updated

July 22, 2026

Results First Posted

July 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations