NCT05696704

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
32mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Jan 2023Dec 2028

First Submitted

Initial submission to the registry

January 13, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2028

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

5 years

First QC Date

January 13, 2023

Last Update Submit

May 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Zarit Burden Inventory (ZBI)

    [Time Frame: through study completion, an average of 6 months]

  • Perceived Stress Scale

    [Time Frame: through study completion, an average of 6 months]

Study Arms (2)

Mindfulness Based Cognitive Therapy

EXPERIMENTAL

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

Behavior Activation

EXPERIMENTAL

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

Other: Behavioral: Behavior Activation

Interventions

Individual tele-therapy 12 to 16 weeks

Also known as: MBCT
Mindfulness Based Cognitive Therapy

Individual therapy 12 to 16 weeks

Also known as: BA
Behavior Activation

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Formal caregivers (who are being paid to take care of the patient)
  • Any informal caregivers with cognitive impairment is identified during the assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University

Lubbock, Texas, 79382, United States

RECRUITING

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Jonathan D Singer, Ph.D.

    jonsinge@ttu.edu

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Casside Street, Ph.D.

CONTACT

Keith Jones, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2023

First Posted

January 25, 2023

Study Start

January 30, 2023

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

May 11, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations