Reducing Mental Health in Informal Caregivers

Not Applicable

Recruiting

• Conditions: Mental Health Issue; Burden, Caregiver; Grief

• Registration Number: NCT05334992
• Lead Sponsor: Texas Tech University

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.

Study Timeline

• Study Start: 2022-02-01
• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-04-11
• Study First Posted: 2022-04-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Prolonged Grief Scale-12 (measuring pre-death grief)	through study completion, an average of 6 months	The 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 Outcome Measures

Name	Time	Method
Zarit Burden Inventory (ZBI)	through study completion, an average of 6 months	Informal 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 Scale	through study completion, an average of 6 months	Informal 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.

Trial Locations

Locations (1)

Texas Tech University; 🇺🇸 Lubbock, Texas, United States