Telehealth to Reduce Mental Health in Family Caregivers

Mental Health Issue Clinical Trial

Official title:

Utilizing Telehealth to Reduce Pre-Death Grief, Burden, and Stress in Family Caregivers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05696704
• Other study ID #: TexasTechU2
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• 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 when provided over telehealth.

Description:

Aim 1: Examine the effects of two individual evidence-based therapies for informal caregivers of dementia patients over telehealth.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• 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

Other:
• Behavioral: Mindfulness Based Cognitive Therapy
Individual tele-therapy 12 to 16 weeks
• Behavioral: 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 activities.	[Time Frame: 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.	[Time Frame: 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.	[Time Frame: through study completion, an average of 6 months]