Mental Health IssueNCT07119710
Telehealth to Improve Quality of Life in Persons Living in Rural Texas
A study testing Cognitive Behavioral Therapy and Cognitive Behavioral therapy with 2 check in calls in people with Mental Health Issue and Quality of Life, run by Texas Tech University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Mental Health Issue, Quality of Life
- What is being tested?
- Cognitive Behavioral Therapy and Cognitive Behavioral therapy with 2 check in calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2023to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- family caregiver of person with all forms of dementia
Who cannot join
- not in another clinical intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Garrison Institute on Aging
Lubbock, Texas, 79413
About this study
Official title: Improving Quality of Life in Persons Living in Rural Texas
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.
Read the detailed description
This two-armed study, for adults living in rural Texas, aims to evaluate current evidence-based practice, Cognitive Behavioral Therapy, for mental health conditions against Cognitive Behavioral Therapy plus two check-in calls a weel.
- Conditions
- Mental Health Issue, Quality of Life
- Being tested
- Cognitive Behavioral Therapy, Cognitive Behavioral therapy with 2 check in calls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Individual tele-therapy 12-16 weeks
Cognitive Behavioral therapy with 2 check in callsBehavioural
Cognitive Behavioral therapy with 2 calls a week
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cognitive Behavioral therapy with 2 check in calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline Weekly before the intervention 1 Month following the intervention 3 Months following the intervention 6 months following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start24 Mar 2023
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119710
- Sponsor's protocol ID
- TexasTechU3
- Status last verified
- May 2026
- First submitted
- 6 May 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Life in Persons Living in Rural Texas
- ClinicalTrials.gov ID
- NCT07119710
- Acronym / sponsor ID
- TexasTechU3
- Conditions
- Mental Health Issue, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This two-armed study, for adults living in rural Texas, aims to evaluate current evidence-based practice, Cognitive Behavioral Therapy, for mental health conditions against Cognitive Behavioral Therapy plus two check-in calls a weel.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavior Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyCognitive Behavior Therapy is an evidence-based practice for mental health conditions and has been shown in numerous studies around the world to be effective. |
| Cognitive Behavior Therapy plus 2 check-in calls a week | Experimental | Behavioral: Cognitive Behavioral therapy with 2 check in callsThis arm will provide the same as the first with the addition of twice-weekly check-in calls between sessions. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- family caregiver of person with all forms of dementia
Key exclusion criteria (1 listed)
- not in another clinical intervention
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 |
|---|---|---|
| Cognitive Behavioral TherapyIndividual tele-therapy 12-16 weeks | Behavioural | Cognitive Behavior Therapy |
| Cognitive Behavioral therapy with 2 check in callsCognitive Behavioral therapy with 2 calls a week | Behavioural | Cognitive Behavior Therapy plus 2 check-in calls a week |
Primary outcome
Pre-death grief (PG-12)
Time frame: Baseline Weekly before the intervention 1 Month following the intervention 3 Months following the intervention 6 months following the intervention
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Cognitive Behavioral therapy with 2 check in calls in people with Mental Health Issue and Quality of Life, run by Texas Tech University 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Singer, Ph.D. (17757228066, jonsinge@ttu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-death grief (PG-12) (time frame: Baseline Weekly before the intervention 1 Month following the intervention 3 Months following the intervention 6 months following the intervention). 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 15 May 2026.