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NCT Number: NCT05334992

Improving Mental Health for Care Partners of Persons With AD/ADRD

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

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Key information

Conditions

Mental Health Issue Behavior Behavioral Symptoms Burden, Caregiver Caregiver Burden Grief Stress, Psychological

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, PhD

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.

Aim 2: Examine the effects of a modified evidence-based group therapy for informal caregivers of dementia patients.

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

Mindfulness Based Cognitive Therapy

Behavioral

Individual therapy 12 to 16 weeks

Other names: MBCT

Behavior Activation

Behavioral

Individual therapy 12 to 16 weeks

Other names: BA

Primary outcomes

  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 activites.

Secondary outcomes

  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.

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

Reducing Pre-Death Grief, Burden, and Stress in Informal Caregivers: A Group and Individual Therapy Approach

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Apr 19, 2022
Registry last updated
Feb 12, 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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