Mentalizing Imagery Therapy for Caregivers to Address Risk of Elder Mistreatment ((MIT-CARE))

Mentalizing Imagery Therapy for Caregivers to Address Risk of Elder Mistreatment (MIT-CARE)

The purpose of this study is to establish the clinical efficacy of Mentalizing Imagery Therapy (MIT) for Alzheimer's Disease and Related Disorders (ADRD) family caregivers in terms of mentalizing and elder mistreatment (EM) risk factors of stress, depression, and suicidality and to identify the mechanistic impacts of MIT on ADRD family caregivers' mental health,including stress, depression, and suicidality.

Study Overview

• Status: Not yet recruiting
• Conditions: Mental Health
• Intervention / Treatment: Behavioral: Mentalizing Imagery Therapy; Behavioral: Mindfulness Exercises.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wesley Browning, PhD; Phone Number: 256.270.5286; Email: wesley.r.browning@uth.tmc.edu
• Study Contact Backup: Name: Asha Jacob; Phone Number: (713) 500-2187; Email: Asha.P.Jacob@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Wesley Browning, PhD; Phone Number: 256.270.5286; Email: wesley.r.browning@uth.tmc.edu
      • Contact: Asha Jacob; Phone Number: (713) 500-2187; Email: Asha.P.Jacob@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Primary family ADRD caregivers
• Recruited nationally.
• Caring for someone aged 60 or older
• Provide at least 8 hours of care weekly
• Report at least mild depressive symptoms (PHQ-9 ≥5)
• Use a smartphone at least five days per week.

Exclusion Criteria:

• Active psychosis or mania
• A suicide attempt in the last 6 months or current suicidal intent
• Self-reported memory or cognitive complaints
• Unstable medical conditions or planned major surgery
• Moderate to severe substance use disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4 weeks of MIT followed by 4 weeks of ME with 2 weeks of washout period in between	Behavioral: Mentalizing Imagery Therapy; MIT is a 4-week, app-delivered behavioral program integrating guided imagery, mindfulness, and perspective-taking practices designed to enhance mentalizing, emotion regulation, and self compassion. MIT is reinforced by weekly 90-minute virtual group sessions; Behavioral: Mindfulness Exercises.; Mindfulness exercises (ME) is a 4-week, app-delivered program featuring daily self-guided mindfulness practices and reflective exercises aimed at reducing depression and stress.ME is self-guided and does not include group sessions.
Experimental: 4 weeks of ME, followed by 4 weeks of MIT with 2 weeks of washout period in between

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived stress as measured by self-reported daily stress	This is scored on a scale from 0-10, with 0 indicating no stress, and 10 indicating the day was extremely stressful	From Baseline through Week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived stress as measured by Perceived Stress Scale (PSS)	The PSS is a 10-item psychological instrument measuring the degree to which situations in one's life are appraised as stressful. Items are scored from 0-4, with total scores ranging from 0-40. Higher scores indicate greater perceived stress.	Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10
Change in depression as measured by Patient Health Questionnaire-9 (PHQ-9)	PHQ-9 is a 9-item self-report measure used to assess the severity of depressive symptoms . Each item is scored from 0 ("Not at all") to 3 ("Nearly every day"), resulting in a total score ranging from 0 to 27. Higher scores indicate greater depressive symptom severity.	Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10
Depression as measured by self-rated daily depression severity	this will be reported as the number of times participant felt feel depressed, sad, or hopeless each day	From baseline through Week 10
Suicidality as measured by self-reported daily suicidality	this will be reported as the number of times participant felt they would be better off dead or thinking about hurting themselves each day	From baseline through Week 10
Change in Mentalization as Measured by the Mentalization Questionnaire (MZQ)	This is a 15 item questionnaire and each is scored on a 5-point Likert scale for a score range from 15-75. Higher scores often indicate greater mentalizing deficits	Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10
Change in Mindfulness as Measured by the Mindfulness Subscale of the Self-Compassion Scale (SCS)	The subscale consists of 4 items rated on a 5-point Likert scale ranging from 1 ("Almost Never") to 5 ("Almost Always"). Scores are calculated as the mean of the item responses, with higher scores indicating greater mindfulness.	Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10
Change in Self-compassion as measured by the Self-Compassion Scale	This has 26 items rated on a 5-point Likert scale ranging from 1 ("Almost Never") to 5 ("Almost Always"). Scores are calculated by averaging item responses after reverse-scoring negatively worded items. Total scores range from 1 to 5, with higher scores indicating greater self-compassion	Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10
Emotion Regulation as measured by self-reported daily emotion regulation	This will be reported as number of times participant felt angry or anxious and how often they lost control over their behaviors each day	From baseline through Week 10

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Wesley Browning, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Mentalizing Imagery Therapy; Mindfulness Exercises; dementia family caregiver
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being
• Other Study ID Numbers: HSC-SN-25-0900; 5P30AG086563-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No