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Recruiting NCT05696704

Telehealth to Reduce Mental Health in Family Caregivers

No phase Interventional Mental Health Issue Grief Burden, Caregiver

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Behavioral: Mindfulness Based Cognitive Therapy, Behavioral: Behavior Activation.
Who it may be relevant to
Registry conditions: Mental Health Issue, Grief, Burden, Caregiver. Basic parameters: 18 years — 120 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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

Interventions

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

Primary outcome measures

  • Prolonged Grief Scale-12 (measuring pre-death grief) [Time frame: [Time Frame: through study completion, an average of 6 months]]
Secondary outcome measures (2)
  • Zarit Burden Inventory (ZBI) [Time frame: [Time Frame: through study completion, an average of 6 months]]
  • Perceived Stress Scale [Time frame: [Time Frame: through study completion, an average of 6 months]]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Texas Tech University — Lubbock

Identifiers

NCT: NCT05696704 · TexasTechU2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗