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NCT Number: NCT05696704

Telehealth to Reduce Mental Health in Family Caregivers

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.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Tech University

Lubbock, Texas, 79382, United States

Location status: Recruiting

Location contact

Jonathan D Singer, Ph.D.

CONTACT

[email protected]

775-722-8066

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral: Mindfulness Based Cognitive Therapy

Other

Individual tele-therapy 12 to 16 weeks

Other names: MBCT

Behavioral: Behavior Activation

Other

Individual therapy 12 to 16 weeks

Other names: BA

Primary outcomes

  1. Prolonged Grief Scale-12 (measuring pre-death grief)

    Time frame: [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 outcomes

  1. Zarit Burden Inventory (ZBI)

    Time frame: [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: [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.

Study contacts

Contact information is provided by the study sponsor or research team.

Casside Street, Ph.D.

CONTACT

[email protected]

(806) 834-2285

Keith Jones, Ph.D.

CONTACT

[email protected]

(806) 834-8745

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 25, 2023
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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