Clinical trial NCT06055322: 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
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Texas Tech University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Adapted Dialectical Behavior Therapy
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Suicide Cognitions Scale-Revised (SCS-R)
timeFrame: All 18 timepoints
measure: Beck Scale for Suicide Ideation (BSSI)
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Interpersonal Needs Questionnaire (INQ)
timeFrame: through study completion, an average of 6 months
measure: Geriatric Depression Scale (GDS)
timeFrame: through study completion, an average of 6 months
measure: Difficulty in Emotion Regulation Scale (DERS)
timeFrame: through study completion, an average of 6 months
measure: The Distress Tolerance Scale (DTS)
timeFrame: through study completion, an average of 6 months
measure: Interpersonal Sensitivity Scale (INT)
timeFrame: through study completion, an average of 6 months
measure: The Mindful Attention Awareness Scale (MAAS)
timeFrame: through study completion, an average of 6 months
measure: DBT Acceptability Measure
timeFrame: through study completion, an average of 6 months
measure: Zarit Burden Interview (ZBI)
timeFrame: through study completion, an average of 6 months
measure: Short Form Health Survey (SF-12)
timeFrame: through study completion, an average of 6 months
measure: Heart Rate Variability (HRV)
timeFrame: through study completion, an average of 6 months
measure: Inflammation Markers
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Garrison Institute on Aging
state: Texas
Study officials:
References: