NCT05334992

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

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 Feb 2022

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 Progress62%
Feb 2022Dec 2028

Study Start

First participant enrolled

February 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

6.9 years

First QC Date

March 21, 2022

Last Update Submit

February 9, 2026

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 activites.

    through study completion, an average of 6 months

Secondary Outcomes (2)

  • Zarit Burden Inventory (ZBI)

    through study completion, an average of 6 months

  • Perceived Stress Scale

    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.

Behavioral: Mindfulness Based Cognitive Therapy

Behavior Activation

EXPERIMENTAL

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

Behavioral: Behavior Activation

Interventions

Individual therapy 12 to 16 weeks

Also known as: BA
Behavior Activation

Individual therapy 12 to 16 weeks

Also known as: MBCT
Mindfulness Based Cognitive Therapy

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

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

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
Model Details: Mindfulness Based Cognitive Therapy; Behavior Activation; Group Therapy
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2022

First Posted

April 19, 2022

Study Start

February 1, 2022

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations