Telehealth to Reduce Mental Health in Family Caregivers
Utilizing Telehealth to Reduce Pre-Death Grief, Burden, and Stress in Family Caregivers
1 other identifier
interventional
60
1 country
1
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 when provided over telehealth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2023
CompletedFirst Posted
Study publicly available on registry
January 25, 2023
CompletedStudy Start
First participant enrolled
January 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
May 11, 2025
May 1, 2025
5 years
January 13, 2023
May 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 activities.
[Time Frame: through study completion, an average of 6 months]
Secondary Outcomes (2)
Zarit Burden Inventory (ZBI)
[Time Frame: through study completion, an average of 6 months]
Perceived Stress Scale
[Time Frame: through study completion, an average of 6 months]
Study Arms (2)
Mindfulness Based Cognitive Therapy
EXPERIMENTALMindfulness-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
EXPERIMENTALBA Increase reinforcing behaviors in order to influence emotions and cognitions.
Interventions
Individual tele-therapy 12 to 16 weeks
Individual therapy 12 to 16 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Formal caregivers (who are being paid to take care of the patient)
- Any informal caregivers with cognitive impairment is identified during the assessment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Texas Tech University
Lubbock, Texas, 79382, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan D Singer, Ph.D.
jonsinge@ttu.edu
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2023
First Posted
January 25, 2023
Study Start
January 30, 2023
Primary Completion (Estimated)
January 30, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
May 11, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share