Skip to main content
OpenTrials
Completed

NCT Number: NCT06055322

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Suicide Alzheimer Disease Behavior Behavioral Symptoms Brain Diseases Caregiver Burden Central Nervous System Diseases Dementia Depression Inflammation Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Physical Health Self-Injurious Behavior Stress, Psychological Tauopathies

Age range

50 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Garrison Institute on Aging

Lubbock, Texas, 79413, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Adapted Dialectical Behavior Therapy

Behavioral

DBT includes skills training groups, unlike other suicide-specific treatments, with modules on distress tolerance, emotion regulation, interpersonal effectiveness, and mindfulness (Linehan, 2014)

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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.

  8. 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).

  9. 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).

  10. 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).

  11. 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)

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2023
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.