Mental Health
Conditions
Keywords
Mentalizing Imagery Therapy, Mindfulness Exercises, dementia family caregiver
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.
Interventions
BEHAVIORALMentalizing 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
BEHAVIORALMindfulness 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.
Sponsors
The University of Texas Health Science Center, Houston
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in perceived stress as measured by self-reported daily stress | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in perceived stress as measured by Perceived Stress Scale (PSS) | 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. |
| Change in depression as measured by Patient Health Questionnaire-9 (PHQ-9) | 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. |
| Depression as measured by self-rated daily depression severity | From baseline through Week 10 | this will be reported as the number of times participant felt feel depressed, sad, or hopeless each day |
| Suicidality as measured by self-reported daily suicidality | 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 |
| Change in Mentalization as Measured by the Mentalization Questionnaire (MZQ) | 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 |
| Change in Mindfulness as Measured by the Mindfulness Subscale of the Self-Compassion Scale (SCS) | 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. |
| Change in Self-compassion as measured by the Self-Compassion Scale | 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 |
| Emotion Regulation as measured by self-reported daily emotion regulation | 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 |
Countries
United States
Contacts
CONTACTWesley Browning, PhD
CONTACTAsha Jacob
PRINCIPAL_INVESTIGATORWesley Browning, PhD
The University of Texas Health Science Center, Houston
Outcome results
None listed