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Telehealth to Reduce Mental Health in Family Caregivers

Sponsor
Texas Tech University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05696704
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

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 when provided over telehealth.

Condition or Disease Intervention/Treatment Phase
  • Other: Behavioral: Mindfulness Based Cognitive Therapy
  • Other: Behavioral: Behavior Activation
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Utilizing Telehealth to Reduce Pre-Death Grief, Burden, and Stress in Family Caregivers
Anticipated Study Start Date :
Jan 30, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Other: Behavioral: Mindfulness Based Cognitive Therapy
Individual tele-therapy 12 to 16 weeks
Other Names:
  • MBCT

    		•
    Experimental: Behavior Activation

    BA Increase reinforcing behaviors in order to influence emotions and cognitions.

    Other: Behavioral: Behavior Activation
    Individual therapy 12 to 16 weeks
    Other Names:
  • BA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Prolonged Grief Scale-12 (measuring pre-death grief) [[Time Frame: through study completion, an average of 6 months]]

      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.

    Secondary Outcome Measures

    1. Zarit Burden Inventory (ZBI) [[Time Frame: through study completion, an average of 6 months]]

      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.

    2. Perceived Stress Scale [[Time Frame: through study completion, an average of 6 months]]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Texas Tech University Lubbock Texas United States 79382

    Sponsors and Collaborators

    • Texas Tech University

    Investigators

    • Principal Investigator: Jonathan D Singer, Ph.D., jonsinge@ttu.edu

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Texas Tech University
    ClinicalTrials.gov Identifier:
    NCT05696704
    Other Study ID Numbers:
    • TexasTechU2
    First Posted:
    Jan 25, 2023
    Last Update Posted:
    Jan 25, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Caregiver Burden

    Study Results

    No Results Posted as of Jan 25, 2023