Reducing Suicide Risk Among Aging Caregivers of Persons With AD/ADRD

May 11, 2026 updated by: Texas Tech University

Reducing Suicide Risk Among Aging Caregivers of Persons With AD/ADRD: Adapting, Implementing, and Evaluating Dialectical Behavior Therapy Skills Training Interventions

This project aims to adapt, implement, and evaluate a Dialectical Behavior Therapy skills training group intervention for aging adult family caregivers of person with Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) to reduce suicidality. By adapting this modality, the investigators will provide a scalable intervention tailored for this high-risk population, maximizing the public health impact and improving suicide prevention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Family caregivers of persons with Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD) experience caregiving-related distress and have about 650% higher rates of suicide ideation (SI; 32.32%) compared to the general population (4.3%). Dialectical Behavior Therapy (DBT), an evidence-based intervention for suicide, addresses multiple areas of psychosocial functioning. Standard DBT is often too re-source-intensive (6 months to 1 year of weekly individual sessions and 1.5-2.5-hour weekly skills training group sessions) and is not tailored to family caregivers of persons with AD/ADRD with SI, creating a significant barrier to SI treatment. The investigators will develop, implement, and evaluate an adapted DBT skills training groups tailored to the unique experiences and needs of family caregivers of persons with AD/ADRD to reduce suicide-related out-comes most effectively. Our specific aims are: (1) Adapt DBT skills groups for family caregivers (of persons with AD/ADRD) endorsing direct or indirect SI (directly stated SI vs. indirect indicators of SI) to ensure it applies to direct and indirect SI and considers SI underreporting; (2) Evaluate the feasibility, acceptability, and fidelity of the adapted DBT skills groups in this sample; (3) Assess preliminary effectiveness indicators of the adapted DBT skills groups. For Aim 1, a panel of experts and two stakeholders (Garrison Institute on Aging (GIA) staff; family caregivers of a person with AD/ADRD), will inform the adaptation of DBT skills training to family caregiv-ers of persons with AD/ADRD and shorten to 16 weekly, 1-hour skills groups sessions, over 4 months. For Aims 2 and 3, the investigators will implement the adapted DBT skills training groups among family caregivers of persons with AD/ADRD with direct/indirect SI at screening while providing respite, all at GIA. The investigators will collect relevant demo-graphic data from family caregivers and family caregiver-reported data about the person with AD/ADRD. Over 18 time points (baseline, following weekly DBT sessions, follow-up), participants will complete self-report assessments targeting DBT fidelity/acceptably, SI (direct and indirect), and suicide risk correlates. The investigators will also record DBT session to monitor fidelity. The investigators will track participant recruitment, group attendance, retention as feasibility metrics. The investigators will also use innovative methodology by collecting inflammation biomarkers and heart rate variability data as an indirect SI assessment. Lastly, the investigators will conduct focus groups after the intervention for addi-tional qualitative acceptability and feasibility data. The investigators will also survey GIA site staff to evaluate their perceived acceptability and feasibility of the intervention at GIA. Our hypotheses are that 1) our adapted DBT skills group will be feasible, acceptable, and maintain DBT fidelity, and 2) SI (direct and indirect), suicide risk factors, and inflammation will decrease, and heart rate variability will increase post intervention. Our expected outcomes are to have a scalable DBT group intervention for family caregivers of persons with ADRD, indications of feasibility and acceptability, and preliminary effectiveness indicators. This work will provide a life-saving suicide prevention approach for family caregivers of persons with AD/ADRD, provide students with multidisciplinary research experiences, and significantly strengthen our university research environment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Lubbock, Texas, United States, 79413
        • Garrison Institute on Aging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • being age 50 and over (as most informal caregivers of persons with AD/ADRD are 50 or older; AARP, 2020; Chi et al., 2019)
  • being the primary informal caregiver
  • living with an AD/ADRD-diagnosed patient
  • being willing to be prodded for bloodspots
  • demonstrating English-fluency
  • endorsing a direct or indirect SI/suicide risk
  • Eligible individuals will score above clinical cutoffs for SI/suicide risk on at least 1 of 3 measures: the Suicide Behavior Questionnaire-R (SBQ-R; score > 6; Osman et al., 2002), Interpersonal Needs Question-naire (INQ; thwarted belonging score > 35; and perceived burden > 17; Mitchell et al., 2020) or the Geriatric De-pression Scale (GDS; score > 5 Heisel et al., 2005).

Exclusion Criteria:

• Participants with neurocognitive impairment will be excluded (a Mini-Mental State Exam score ≤ 23; Folstein et al., 1975; Kochhann et al., 2010)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Adapted Dialectical Behavior Therapy
Adapting Dialectical Behavior Therapy to focus on reducing suicide ideation for family caregivers of persons with AD/ADRD
Behavioral: Adapted Dialectical Behavior Therapy
DBT includes skills training groups, unlike other suicide-specific treatments, with modules on distress tolerance, emotion regulation, interpersonal effectiveness, and mindfulness (Linehan, 2014)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Suicide Cognitions Scale-Revised (SCS-R)
Time Frame: All 18 timepoints
The SCS-R is a 16-item self-report measure that assesses a variety of beliefs, attitudes, expectations, and perceptions associated with the emergence of suicidal thoughts. Importantly, the SCS-R does not directly ask about suicidal thoughts or behaviors, making it an indirect suicide ideation assessment. Previous studies have found that the SCS-R demonstrates excellent internal consistency (α = .96-.98; Bryan et al., 2021; Moscardini et al., 2020).
All 18 timepoints
Beck Scale for Suicide Ideation (BSSI)
Time Frame: through study completion, an average of 6 months
The BSSI is a 21-item self-report measure with 19 items to evaluate the current intensity of patients' specific attitudes, behaviors, and plans for suicide, including desire for suicide (suicide ideation) and desire for death generally (death ideation). Two items also assess suicide attempt history and intent during the most recent suicide attempt (if applicable). The BSSI has demonstrated good psychometric properties and has good predictive validity for suicide death (Beck et al., 1997; Brown et al., 2000), including among aging adults (Witte et al., 2006).
through study completion, an average of 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Interpersonal Needs Questionnaire (INQ)
Time Frame: through study completion, an average of 6 months
The INQ is a 15-item self-report assessment of thwarted belonging (9 items; scores range from 9 to 63) and perceived burden (6 items; scores range from 6 to 42). The INQ has demonstrated strong psychometric properties, including construct validity among psychiatric outpatients and aging adults (Hill et al., 2015; Van Orden et al., 2012) and strong internal consistency thwarted belonging (.91) and perceived burden (.94; Mitchell et al., 2020).
through study completion, an average of 6 months
Geriatric Depression Scale (GDS)
Time Frame: through study completion, an average of 6 months
The GDS-15 is a 15-item self-report measure of depression, includes a 5-item subscale to assess for suicide ideation, and has been used as a screener for suicide ideation (Cheng et al., 2010). The GDS has been found to have good internal consistency when used with informal caregivers of patients with AD/ADRD (α = .73).
through study completion, an average of 6 months
Difficulty in Emotion Regulation Scale (DERS)
Time Frame: through study completion, an average of 6 months
The DERS is an 18-item, six-subscale self-report measure of emotion regulation. The subscales assess respondents' acceptance of emotions, ability to engage in goal-directed behavior when distressed, impulse control, awareness of emotions, access to strategies for regulation, and clarity of emotions. The DERS-18 subscales have demonstrated good internal consistency (α = .77-.90).
through study completion, an average of 6 months
The Distress Tolerance Scale (DTS)
Time Frame: through study completion, an average of 6 months
The DTS is a 15-item self-report measure of the degree to which individuals experience negative emotions as intolerable. The DTS has demonstrated good internal consistency (α = .91; Anestis et al., 2007).
through study completion, an average of 6 months
Interpersonal Sensitivity Scale (INT)
Time Frame: through study completion, an average of 6 months
The INT is a 10-item self-report measure that assesses participants' abilities to manage relationships via processes associated with interpersonal effectiveness. The INT has demonstrated good internal consistency (α = .91; Lenz et al., 2016).
through study completion, an average of 6 months
The Mindful Attention Awareness Scale (MAAS)
Time Frame: through study completion, an average of 6 months
The MAAS is a 15-item single-dimension self-report measure of trait mindfulness, measuring the frequency of open and receptive attention to and awareness of ongoing events and experience. MAAS has demonstrated good internal consistency (α = .89-.93; Black et al., 2012), including among aging adults (e.g., Mally & Fiocco, 2016).
through study completion, an average of 6 months
DBT Acceptability Measure
Time Frame: through study completion, an average of 6 months
This is an 8-item self-report measure assessing participants' perceived acceptability of DBT (e.g., I would participate in this intervention again). Questions are analyzed separately to indicate acceptability of the adapted DBT manual.
through study completion, an average of 6 months
Zarit Burden Interview (ZBI)
Time Frame: through study completion, an average of 6 months
The ZBI is a 22-item self-report measure of caregiver burden. It has been validated with informal caregivers of patients with AD/ADRD and has been shown to have good internal consistency (0.83-0.92; Hebert et al., 2000; Bedard et al., 2001) and validity (Hebert et al., 2000).
through study completion, an average of 6 months
Short Form Health Survey (SF-12)
Time Frame: through study completion, an average of 6 months
The SF-12 is a 12-item self-report measure of health and has been validated with aging adults (Jakobsson, 2006). The SF-12 is a commonly used instrument to measure health-related quality of life at various ages. The SF-12 has been shown to be psychometrically valid and reliable (Ware et al., 1996; Ware et al., 1997).
through study completion, an average of 6 months
Heart Rate Variability (HRV)
Time Frame: through study completion, an average of 6 months
HRV will be evaluated using Empatica E4 bands, providing autonomic nervous system arousal data, including heart rate. HRV has been used with aging adults and with informal caregivers in past studies (e.g., Brown et al., 2018; James et al., 2021).
through study completion, an average of 6 months
Inflammation Markers
Time Frame: through study completion, an average of 6 months
CRP and IL-6, Blood for analysis will be collected on filter paper (dried blood spots) Dried blood spots are a non-invasive and low-cost method of collecting blood that involves a finger prick with a lancet and blotting the blood onto filter paper (Miller)
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Tech University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TexasTechU4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators will not be providing any individual participant data. It will all be aggregate

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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