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

9. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 4 weeks of MIT followed by 4 weeks of ME with 2 weeks of washout period in between
Adfærdsmæssigt: 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
Adfærdsmæssigt: 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.
Eksperimentel: 4 weeks of ME, followed by 4 weeks of MIT with 2 weeks of washout period in between

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The University of Texas Health Science Center, Houston

Samarbejdspartnere

National Institute on Aging (NIA)

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. september 2027

Studieafslutning (Anslået)

30. juni 2028

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Mentalt helbred

Kliniske forsøg med Mentalizing Imagery Therapy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Greece

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner