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Improving Mental Health for Care Partners of Persons With AD/ADRD

Reducing Pre-Death Grief, Burden, and Stress in Informal Caregivers: A Group and Individual Therapy Approach

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05334992
Enrollment
60
Registered
2022-04-19
Start date
2022-02-01
Completion date
2028-12-31
Last updated
2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burden, Caregiver, Grief, Mental Health Issue

Brief summary

The overarching goal of this project is to evaluate if evidence-based interventions can reduce PDG, burden, and stress in informal caregivers of individuals with dementia

Detailed description

Aim 1: Examine the effects of two individual evidence-based therapies for informal caregivers of dementia patients. Aim 2: Examine the effects of a modified evidence-based group therapy for informal caregivers of dementia patients.

Interventions

BEHAVIORALMindfulness Based Cognitive Therapy

Individual therapy 12 to 16 weeks

Individual therapy 12 to 16 weeks

Sponsors

Texas Tech University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Mindfulness Based Cognitive Therapy; Behavior Activation; Group Therapy

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

* Participants must be informal caregivers (e.g., spouse; child; close friend) of individuals with dementia * Informal caregivers can be family members or close friends * Adults (18 to 89 years old) who read, write, and speak in English * Mental Health Diagnosis (e.g., Generalized Anxiety Disorder; Major Depressive Disorder

Exclusion criteria

* Formal caregivers (who are being paid to take care of the patient) * Any informal caregivers with cognitive impairment is identified during the assessment.

Design outcomes

Primary

MeasureTime frameDescription
Prolonged Grief Scale-12 (measuring pre-death grief)through study completion, an average of 6 monthsThe PG-12 (range 11-55; higher scores mean higher pre-death grief), which is used to measure pre-death grief will be used to measure grief of having a loved one live with a life limiting illness and no longer be able to engage in valued activites.

Secondary

MeasureTime frameDescription
Zarit Burden Inventory (ZBI)through study completion, an average of 6 monthsInformal caregivers, usually family member, have an increase in burden or feeling they are overwhelmed by their current circumstances. The ZBI is between 0-48, higher scores indicating higher burden.
Perceived Stress Scalethrough study completion, an average of 6 monthsInformal caregivers, usually family members, are unpaid and have a tendency to feel tense and emotionally drained do to caregiving. Scores range from 0-40 with higher scores indicating higher rates of stress.

Countries

United States

Contacts

CONTACTCasside Street, Ph.D
casside.street@ttu.edu(806) 834-2285
CONTACTKeith Jones, Ph.D
keith.jones@ttu.edu(806) 834-8745
PRINCIPAL_INVESTIGATORJonathan D Singer, Ph.D

jonsinge@ttu.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026