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

NCT06055322 | Recruiting DMC

• 1 other identifier: TexasTechU4
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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).

  All 18 timepoints

• 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).

  through study completion, an average of 6 months

Secondary Outcomes (11)

• Interpersonal Needs Questionnaire (INQ)

  through study completion, an average of 6 months

• Geriatric Depression Scale (GDS)

  through study completion, an average of 6 months

• Difficulty in Emotion Regulation Scale (DERS)

  through study completion, an average of 6 months

• The Distress Tolerance Scale (DTS)

  through study completion, an average of 6 months

• Interpersonal Sensitivity Scale (INT)

  through study completion, an average of 6 months

Study Arms (1)

Adapted Dialectical Behavior Therapy

EXPERIMENTAL

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

Behavioral: Adapted Dialectical Behavior Therapy

Interventions

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)

Adapted Dialectical Behavior Therapy

Eligibility Criteria

• Age: 50 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Texas Tech University: lead

Study Sites (1)

Garrison Institute on Aging

Lubbock, Texas, 79413, United States

RECRUITING

MeSH Terms

Conditions

Suicide; Depression; Caregiver Burden; Inflammation; Alzheimer Disease

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Stress, Psychological; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Jonathan D Singer, PhD

CONTACT

7757228066; jonsinge@ttu.edu

Sean Mitchell, PhD

CONTACT

8068347593; sean.mitchell@ttu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Adapted Dialectical Behavior Therapy

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 26, 2023
• Study Start: January 7, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)