Reducing Mental Health in Informal Caregivers

Mental Health Issue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05334992
• Other study ID #: TexasTechU
• Secondary ID: tech
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Texas Tech University
• Contact: Casside Street, Ph.D
• Phone: (806) 834-2285
• Email: casside.street[@]ttu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caregiver Burden
• Grief
• Mental Health Issue

Intervention

Behavioral:
• Mindfulness Based Cognitive Therapy
Individual therapy 12 to 16 weeks
• Behavior Activation
Individual therapy 12 to 16 weeks

Locations

Country	Name	City	State
United States	Texas Tech University	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolonged Grief Scale-12 (measuring pre-death grief)	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.	through study completion, an average of 6 months
Secondary	Zarit Burden Inventory (ZBI)	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.	through study completion, an average of 6 months
Secondary	Perceived Stress Scale	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.	through study completion, an average of 6 months