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NCT Number: NCT07648238

Mentalizing Imagery Therapy for Caregivers to Address Risk of Elder Mistreatment

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.

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Key information

Conditions

Mental Health Behavior Personal Satisfaction Psychological Well-Being

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Change in perceived stress as measured by self-reported daily stress

    Time frame: From Baseline through Week 10

    This is scored on a scale from 0-10, with 0 indicating no stress, and 10 indicating the day was extremely stressful

Secondary outcomes

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

    Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10

    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.

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

    Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10

    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.

  3. Depression as measured by self-rated daily depression severity

    Time frame: From baseline through Week 10

    this will be reported as the number of times participant felt feel depressed, sad, or hopeless each day

  4. Suicidality as measured by self-reported daily suicidality

    Time frame: From baseline through Week 10

    this will be reported as the number of times participant felt they would be better off dead or thinking about hurting themselves each day

  5. Change in Mentalization as Measured by the Mentalization Questionnaire (MZQ)

    Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10

    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

  6. Change in Mindfulness as Measured by the Mindfulness Subscale of the Self-Compassion Scale (SCS)

    Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10

    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.

  7. Change in Self-compassion as measured by the Self-Compassion Scale

    Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10

    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

  8. Emotion Regulation as measured by self-reported daily emotion regulation

    Time frame: From baseline through Week 10

    This will be reported as number of times participant felt angry or anxious and how often they lost control over their behaviors each day

Study contacts

Contact information is provided by the study sponsor or research team.

Asha Jacob

CONTACT

[email protected]

(713) 500-2187

Wesley Browning, PhD

CONTACT

[email protected]

256.270.5286

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: (MIT-CARE)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 15, 2026
Registry last updated
Jun 15, 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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