Reducing Mental Health in Informal Caregivers

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

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

Study Overview

• Status: Recruiting
• Conditions: Grief; Mental Health Issue; Burden, Caregiver
• Intervention / Treatment: Behavioral: Mindfulness Based Cognitive Therapy; Behavioral: Behavior Activation

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Casside Street, Ph.D; Phone Number: (806) 834-2285; Email: casside.street@ttu.edu
• Study Contact Backup: Name: Keith Jones, Ph.D; Phone Number: (806) 834-8745; Email: keith.jones@ttu.edu

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79382
      • Recruiting
      • Texas Tech University
      • Contact: Jonathan D Singer, PhD; Phone Number: 775-722-8066; Email: jonsinge@ttu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Mindfulness Based Cognitive Therapy; Individual therapy 12 to 16 weeks; Other Names: MBCT
Experimental: Behavior Activation; BA Increase reinforcing behaviors in order to influence emotions and cognitions.	Behavioral: Behavior Activation; Individual therapy 12 to 16 weeks; Other Names: BA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Texas Tech University
• Investigators: Principal Investigator: Jonathan D Singer, Ph.D, jonsinge@ttu.edu

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• Other Study ID Numbers: TexasTechU; tech (Other Identifier: TexasTechU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No