Mental Health(MIT-CARE)NCT07648238
Mentalizing Imagery Therapy for Caregivers to Address Risk of Elder Mistreatment
A study testing Mentalizing Imagery Therapy and Mindfulness Exercises. in people with Mental Health, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mental Health
- What is being tested?
- Mentalizing Imagery Therapy and Mindfulness Exercises.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Wesley Browning, PhD, 256.270.5286, wesley.r.browning@uth.tmc.edu
Asha Jacob, (713) 500-2187, Asha.P.Jacob@uth.tmc.edu
About this study
Official title: 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.
- Conditions
- Mental Health
- Being tested
- Mentalizing Imagery Therapy, Mindfulness Exercises.
- Keywords
- Mentalizing Imagery Therapy, Mindfulness Exercises, dementia family caregiver
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentalizing Imagery TherapyBehavioural
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.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 4 weeks of MIT followed by 4 weeks of ME with 2 weeks of washout period in between | Experimental | Not described Receives: 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Baseline through Week 10
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: From baseline through Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Wesley Browning, The University of Texas Health Science Center, Houston
- Investigators
- Wesley Browning, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648238
- Sponsor's protocol ID
- HSC-SN-25-0900
- Other IDs
- 5P30AG086563-02
- Acronym
- (MIT-CARE)
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mentalizing Imagery Therapy for Caregivers to Address Risk of Elder Mistreatment (MIT-CARE)
- ClinicalTrials.gov ID
- NCT07648238
- Acronym / sponsor ID
- (MIT-CARE) / HSC-SN-25-0900
- Conditions
- Mental Health
- Keywords
- Mentalizing Imagery Therapy, Mindfulness Exercises, dementia family caregiver
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentalizing Imagery TherapyMIT 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 | Behavioural | 4 weeks of MIT followed by 4 weeks of ME with 2 weeks of washout period in between |
| 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. | Behavioural | 4 weeks of MIT followed by 4 weeks of ME with 2 weeks of washout period in between |
Primary outcome
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wesley Browning, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentalizing Imagery Therapy and Mindfulness Exercises. in people with Mental Health, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wesley Browning, PhD (256.270.5286, wesley.r.browning@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived stress as measured by self-reported daily stress (time frame: From Baseline through Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.