NCT05433662

Brief Summary

Older adults have been disproportionately impacted and distressed by the 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 65 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 Jun 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

Study Start

First participant enrolled

June 15, 2022

Completed
6 days until next milestone

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
2.5 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
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

2.5 years

First QC Date

June 21, 2022

Last Update Submit

January 24, 2025

Conditions

Keywords

Older adultacceptance and commitment therapytelehealthpandemic

Outcome Measures

Primary Outcomes (3)

  • Acceptability of study protocol - retention

    Rate of study completion

    Through study completion, approximately 2 years

  • Feasibility of study protocol - telehealth

    Percent of participants who have telehealth capability for duration of intervention

    Through study completion, approximately 2 years

  • Acceptability of intervention - group attendance

    Percent of participants who attend 70% or more of intervention sessions

    Through study completion, approximately 2 years

Other Outcomes (5)

  • Acceptability of study protocol - enrollment

    Throughout active enrollment period, approximately 1.5 years

  • Acceptability of study protocol - assessment completion

    Through study completion, approximately 2 years

  • Feasibility of study protocol - timeline

    Through study completion, approximately 2 years

  • +2 more other outcomes

Study Arms (1)

Veterans

Veterans will be ages 65 and older, cognitively intact, and experiencing pandemic-related stress.

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

Interventions

Pan-ACT is a 10-session, closed group, transdiagnostic intervention for older adults.

Also known as: Acceptance and Commitment Therapy (ACT); ACT for Older Adults; The Third ACT
Veterans

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Veterans ages 50 and older receiving services at the Tuscaloosa VA Medical Center (TVAMC) will be 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

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 CBT-based 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

Study Officials

  • Lori Lynne Davis, MD AB

    Tuscaloosa VA Medical Center, Tuscaloosa, AL

    PRINCIPAL INVESTIGATOR

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

June 15, 2022

Primary Completion

December 31, 2024

Study Completion

January 23, 2025

Last Updated

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Data sets will have no identifying information of participants (participants ages above 89 will be coded as "90 or above" in accordance with HIPAA regulations). In addition, no Clinical Site identifiers beyond the code numbers will be included in the data set. A "dictionary" dataset will also be included which will include description labels for all the variables. The archives will also include the data collection forms and data collection instructions, including coding schemes and scoring algorithms, and study manuals. These documents will be archived as Adobe Acrobat (.pdf) files. No audio files, video files, or qualitative transcripts will be shared.

Locations