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

9. juni 2026 oppdatert av: Wesley Browning, The University of Texas Health Science Center, Houston

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 4 weeks of MIT followed by 4 weeks of ME with 2 weeks of washout period in between
Atferdsmessig: 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
Atferdsmessig: 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.
Eksperimentell: 4 weeks of ME, followed by 4 weeks of MIT with 2 weeks of washout period in between

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in perceived stress as measured by self-reported daily stress
Tidsramme: 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
From Baseline through Week 10

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in perceived stress as measured by Perceived Stress Scale (PSS)
Tidsramme: 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.
Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10
Change in depression as measured by Patient Health Questionnaire-9 (PHQ-9)
Tidsramme: 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.
Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10
Depression as measured by self-rated daily depression severity
Tidsramme: From baseline through Week 10
this will be reported as the number of times participant felt feel depressed, sad, or hopeless each day
From baseline through Week 10
Suicidality as measured by self-reported daily suicidality
Tidsramme: 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
From baseline through Week 10
Change in Mentalization as Measured by the Mentalization Questionnaire (MZQ)
Tidsramme: 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
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)
Tidsramme: 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.
Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10
Change in Self-compassion as measured by the Self-Compassion Scale
Tidsramme: 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
Baseline, Week 2, Week 4, Week 6, Week 8, and Week 10
Emotion Regulation as measured by self-reported daily emotion regulation
Tidsramme: 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
From baseline through Week 10

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The University of Texas Health Science Center, Houston

Samarbeidspartnere

National Institute on Aging (NIA)

Etterforskere

  • Hovedetterforsker: Wesley Browning, PhD, The University of Texas Health Science Center, Houston

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

30. juni 2028

Datoer for studieregistrering

Først innsendt

9. juni 2026

Først innsendt som oppfylte QC-kriteriene

9. juni 2026

Først lagt ut (Faktiske)

15. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HSC-SN-25-0900
  • 5P30AG086563-02 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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