search
Back to results

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

Primary Purpose

Suicide, Depression, Caregiver Burden

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adapted Dialectical Behavior Therapy
Sponsored by
Texas Tech University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring Suicide Ideation, Older Adults, Family Caregivers, Alzheimer's Disease and Alzheimer's Disease Related Dementias, Dialectical Behavior Therapy

Eligibility Criteria

50 Years - 120 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Adapted Dialectical Behavior Therapy

    Arm Description

    Adapting Dialectical Behavior Therapy to focus on reducing suicide ideation for family caregivers of persons with AD/ADRD

    Outcomes

    Primary Outcome Measures

    Suicide Cognitions Scale-Revised (SCS-R)
    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).
    Beck Scale for Suicide Ideation (BSSI)
    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 Outcome Measures

    Interpersonal Needs Questionnaire (INQ)
    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).
    Geriatric Depression Scale (GDS)
    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).
    Difficulty in Emotion Regulation Scale (DERS)
    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).
    The Distress Tolerance Scale (DTS)
    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).
    Interpersonal Sensitivity Scale (INT)
    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).
    The Mindful Attention Awareness Scale (MAAS)
    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).
    DBT Acceptability Measure
    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.
    Zarit Burden Interview (ZBI)
    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).
    Short Form Health Survey (SF-12)
    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).
    Heart Rate Variability (HRV)
    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).
    Inflammation Markers
    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)

    Full Information

    First Posted
    September 12, 2023
    Last Updated
    September 19, 2023
    Sponsor
    Texas Tech University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06055322
    Brief Title
    Reducing Suicide Risk Among Aging Caregivers of Persons With AD/ADRD
    Official Title
    Reducing Suicide Risk Among Aging Caregivers of Persons With AD/ADRD: Adapting, Implementing, and Evaluating Dialectical Behavior Therapy Skills Training Interventions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    August 31, 2026 (Anticipated)
    Study Completion Date
    August 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Texas Tech University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicide, Depression, Caregiver Burden, Physical Health, Inflammation
    Keywords
    Suicide Ideation, Older Adults, Family Caregivers, Alzheimer's Disease and Alzheimer's Disease Related Dementias, Dialectical Behavior Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Adapted Dialectical Behavior Therapy
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Adapted Dialectical Behavior Therapy
    Arm Type
    Experimental
    Arm Description
    Adapting Dialectical Behavior Therapy to focus on reducing suicide ideation for family caregivers of persons with AD/ADRD
    Intervention Type
    Behavioral
    Intervention Name(s)
    Adapted Dialectical Behavior Therapy
    Intervention Description
    DBT includes skills training groups, unlike other suicide-specific treatments, with modules on distress tolerance, emotion regulation, interpersonal effectiveness, and mindfulness (Linehan, 2014)
    Primary Outcome Measure Information:
    Title
    Suicide Cognitions Scale-Revised (SCS-R)
    Description
    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).
    Time Frame
    All 18 timepoints
    Title
    Beck Scale for Suicide Ideation (BSSI)
    Description
    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).
    Time Frame
    through study completion, an average of 6 months
    Secondary Outcome Measure Information:
    Title
    Interpersonal Needs Questionnaire (INQ)
    Description
    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).
    Time Frame
    through study completion, an average of 6 months
    Title
    Geriatric Depression Scale (GDS)
    Description
    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).
    Time Frame
    through study completion, an average of 6 months
    Title
    Difficulty in Emotion Regulation Scale (DERS)
    Description
    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).
    Time Frame
    through study completion, an average of 6 months
    Title
    The Distress Tolerance Scale (DTS)
    Description
    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).
    Time Frame
    through study completion, an average of 6 months
    Title
    Interpersonal Sensitivity Scale (INT)
    Description
    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).
    Time Frame
    through study completion, an average of 6 months
    Title
    The Mindful Attention Awareness Scale (MAAS)
    Description
    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).
    Time Frame
    through study completion, an average of 6 months
    Title
    DBT Acceptability Measure
    Description
    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.
    Time Frame
    through study completion, an average of 6 months
    Title
    Zarit Burden Interview (ZBI)
    Description
    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).
    Time Frame
    through study completion, an average of 6 months
    Title
    Short Form Health Survey (SF-12)
    Description
    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).
    Time Frame
    through study completion, an average of 6 months
    Title
    Heart Rate Variability (HRV)
    Description
    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).
    Time Frame
    through study completion, an average of 6 months
    Title
    Inflammation Markers
    Description
    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)
    Time Frame
    through study completion, an average of 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jonathan D Singer, PhD
    Phone
    7757228066
    Email
    jonsinge@ttu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sean Mitchell, PhD
    Phone
    8068347593
    Email
    sean.mitchell@ttu.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The investigators will not be providing any individual participant data. It will all be aggregate

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs