Reducing Mental Health in Informal Caregivers

Not Applicable

Recruiting

• Conditions: Mental Health Issue; Burden, Caregiver; Grief
• Interventions: Behavioral: Mindfulness Based Cognitive Therapy; Behavioral: Behavior Activation

• 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

Arm && Interventions

Group	Intervention	Description
Mindfulness Based Cognitive Therapy	Mindfulness Based Cognitive Therapy	Mindfulness-Based Cognitive Therapy (MBCT) combines the ideas of cognitive therapy with meditative practices and attitudes based on the cultivation of mindfulness. The heart of this work lies in becoming acquainted with the modes of mind that often characterize mood disorders while simultaneously learning to develop a new relationship to them.
Behavior Activation	Behavior Activation	BA Increase reinforcing behaviors in order to influence emotions and cognitions.

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