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Not yet recruiting NCT07648238

Mentalizing Imagery Therapy for Caregivers to Address Risk of Elder Mistreatment

No phase Interventional Mental Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mentalizing Imagery Therapy, Mindfulness Exercises..
Who it may be relevant to
Registry conditions: Mental Health. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change in perceived stress as measured by self-reported daily stress [Time frame: From Baseline through Week 10]
Secondary outcome measures (8)
  • 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]
  • 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]
  • Depression as measured by self-rated daily depression severity [Time frame: From baseline through Week 10]
  • Suicidality as measured by self-reported daily suicidality [Time frame: From baseline through Week 10]
  • Change in Mentalization as Measured by the Mentalization Questionnaire (MZQ) [Time frame: 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) [Time frame: Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10]
  • 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]
  • Emotion Regulation as measured by self-reported daily emotion regulation [Time frame: From baseline through Week 10]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT07648238 · HSC-SN-25-0900 · 5P30AG086563-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗