Mentalizing Imagery Therapy for Caregivers to Address Risk of Elder Mistreatment

NCT07648238 | Not Yet Recruiting

• 2 other identifiers: HSC-SN-25-09005P30AG086563-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health

Keywords

Mentalizing Imagery Therapy; Mindfulness Exercises; dementia family caregiver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in perceived stress as measured by Perceived Stress Scale (PSS)

  Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10

• Change in depression as measured by Patient Health Questionnaire-9 (PHQ-9)

  Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10

• Depression as measured by self-rated daily depression severity

  From baseline through Week 10

• Suicidality as measured by self-reported daily suicidality

  From baseline through Week 10

• Change in Mentalization as Measured by the Mentalization Questionnaire (MZQ)

  Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10

Study Arms (2)

4 weeks of MIT followed by 4 weeks of ME with 2 weeks of washout period in between

EXPERIMENTAL

Behavioral: Mentalizing Imagery Therapy; Behavioral: Mindfulness Exercises.

4 weeks of ME, followed by 4 weeks of MIT with 2 weeks of washout period in between

EXPERIMENTAL

Interventions

Mentalizing Imagery Therapy BEHAVIORAL

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

4 weeks of MIT followed by 4 weeks of ME with 2 weeks of washout period in between

Mindfulness Exercises. BEHAVIORAL

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.

4 weeks of MIT followed by 4 weeks of ME with 2 weeks of washout period in between

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Wesley Browning, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wesley Browning, PhD

CONTACT

256.270.5286; wesley.r.browning@uth.tmc.edu

Asha Jacob

CONTACT

(713) 500-2187; Asha.P.Jacob@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)