Back to resultsReducing Mental Health in Informal Caregivers
Primary Purpose
Mental Health Issue, Grief, Burden, Caregiver
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Cognitive Therapy
Behavior Activation
Sponsored by
About this trial
This is an interventional treatment trial for Mental Health Issue
Eligibility Criteria
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.
Sites / Locations
- Texas Tech UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mindfulness Based Cognitive Therapy
Behavior Activation
Arm Description
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.
BA Increase reinforcing behaviors in order to influence emotions and cognitions.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05334992
Brief Title
Reducing Mental Health in Informal Caregivers
Official Title
Reducing Pre-Death Grief, Burden, and Stress in Informal Caregivers: A Group and Individual Therapy Approach
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Issue, Grief, Burden, Caregiver
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Mindfulness Based Cognitive Therapy; Behavior Activation; Group Therapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Based Cognitive Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Behavior Activation
Arm Type
Experimental
Arm Description
BA Increase reinforcing behaviors in order to influence emotions and cognitions.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Cognitive Therapy
Other Intervention Name(s)
MBCT
Intervention Description
Individual therapy 12 to 16 weeks
Intervention Type
Behavioral
Intervention Name(s)
Behavior Activation
Other Intervention Name(s)
BA
Intervention Description
Individual therapy 12 to 16 weeks
Primary Outcome Measure Information:
Title
Prolonged Grief Scale-12 (measuring pre-death grief)
Description
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.
Time Frame
through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Zarit Burden Inventory (ZBI)
Description
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.
Time Frame
through study completion, an average of 6 months
Title
Perceived Stress Scale
Description
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.
Time Frame
through study completion, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Casside Street, Ph.D
Phone
(806) 834-2285
Email
casside.street@ttu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Keith Jones, Ph.D
Phone
(806) 834-8745
Email
keith.jones@ttu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan D Singer, Ph.D
Organizational Affiliation
jonsinge@ttu.edu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Tech University
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79382
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan D Singer, PhD
Phone
775-722-8066
Email
jonsinge@ttu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Reducing Mental Health in Informal Caregivers
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