NCT07119710

Brief Summary

The overarching goal of this project is to evaluate a current evidence-based practice, Cognitive Behavioral Therapy, for mental health conditions against Cognitive Behavioral Therapy plus two check-in calls a week for adults living in rural Texas.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Mar 2023Dec 2028

Study Start

First participant enrolled

March 24, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

5.7 years

First QC Date

May 6, 2025

Last Update Submit

August 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pre-death grief (PG-12)

    PG-12 is a questionnaire used to assess grief experiences before the death of a person will a life limiting illness. It is designed for caregivers of individuals with life limiting illnesses, including those with cancer or dementia. The PG-12 helps identify individuals at risk for prolonged grief disorder (PGD) and can be used in conjunction with other assessments.

    Baseline Weekly before the intervention 1 Month following the intervention 3 Months following the intervention 6 months following the intervention

Study Arms (2)

Cognitive Behavior Therapy

EXPERIMENTAL

Cognitive Behavior Therapy is an evidence-based practice for mental health conditions and has been shown in numerous studies around the world to be effective.

Behavioral: Cognitive Behavioral Therapy

Cognitive Behavior Therapy plus 2 check-in calls a week

EXPERIMENTAL

This arm will provide the same as the first with the addition of twice-weekly check-in calls between sessions.

Behavioral: Cognitive Behavioral therapy with 2 check in calls

Interventions

Individual tele-therapy 12-16 weeks

Cognitive Behavior Therapy

Cognitive Behavioral therapy with 2 calls a week

Cognitive Behavior Therapy plus 2 check-in calls a week

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • family caregiver of person with all forms of dementia

You may not qualify if:

  • not in another clinical intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Garrison Institute on Aging

Lubbock, Texas, 79413, United States

RECRUITING

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Jonathan Singer, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2025

First Posted

August 13, 2025

Study Start

March 24, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

August 13, 2025

Record last verified: 2025-08

Locations