Health TrialsbyHealthPanel

Mentalizing Imagery Therapy for Caregivers to Address Risk of Elder Mistreatment

ConditionMental Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary family ADRD caregivers

Recruited nationally.

Caring for someone aged 60 or older

Provide at least 8 hours of care weekly

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: 4 weeks of MIT followed by 4 weeks of ME with 2 weeks of washout period in betweenExperimental treatment 2 interventions
Group B: 4 weeks of ME, followed by 4 weeks of MIT with 2 weeks of washout period in betweenExperimental treatment 0 interventions

Trial outcomes

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

Time frame
From Baseline through Week 10

Secondary outcomes

1

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.

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

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.

Time frame
Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10
3

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

Time frame
From baseline through Week 10
4

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

Time frame
From baseline through Week 10

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: