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Personalizing Interventions Using Real-World Interactions

10. december 2020 opdateret af: Kyle S. Minor, Indiana University

Personalizing Interventions Using Real-World Interactions: Improving Symptoms and Social Functioning in Schizophrenia With Tailored Metacognitive Therapy

Social functioning deficits are among the most disabling and difficult to treat aspects of schizophrenia. An essential component of social functioning is metacognition-a process that is profoundly disrupted in schizophrenia and represents the ability to reflect upon the mental states of oneself and others. To date, treatment efforts in schizophrenia have been hindered by barriers in accurately monitoring client's real-world social interactions. Recently, wearable technologies have evolved to provide therapists with innovative, ecologically-valid tools. The Electronically Activated Recorder is a wearable audio recorder that collects behavioral samples at pre-programmed intervals; it holds great promise as a method for yielding concrete, real-world examples of social interactions that can be used by therapists in session to enhance metacognition. Despite the immense costs of social functioning deficits, no previous studies have investigated whether functioning can be improved by integrating wearable audio recorders with psychosocial interventions.

By enhancing therapy using a wearable recording device, this proposal's primary goal is to implement a novel intervention that targets metacognitive deficits to improve social functioning. The novel intervention will be tailored to individual clients-based on the content of recorded social interactions-in a way that is not possible using traditional psychotherapy. This will allow clients and therapists to step out of the therapy room by offering a window into how clients process material in real-world interactions. In this study, a randomized controlled trial will be conducted with two schizophrenia groups receiving six months of individualized: 1) Metacognition Reflection and Insight Therapy (MERIT) alone (Standard MERIT); and 2) Tailored MERIT using wearable audio recorders. In this study, our specific aims will test feasibility, effectiveness, and acceptability of Tailored MERIT.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

34

Fase

  • Ikke anvendelig

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

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Positive screen for metacognitive dysfunction
  • Serious Mental Illness diagnosis (schizophrenia-spectrum)
  • Age 18-60
  • English fluency
  • Currently in non-acute phase of illness

Exclusion Criteria:

  • Inability to provide informed consent
  • Current substance dependence
  • Documented intellectual disability

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Standard MERIT
24 sessions of Metacognition Reflection and Insight Therapy
see arm description
Eksperimentel: Tailored MERIT
24 sessions of personalized Metacognition Reflection and Insight Therapy (sessions personalized using real-world interactions)
see arm description

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Global Functioning Scale: Social (GFS)
Tidsramme: Change from baseline social functioning to social functioning after 6 months of MERIT
10-point measure of social functioning (1 to 10, with increasing scores indicating greater social functioning)
Change from baseline social functioning to social functioning after 6 months of MERIT
Metacognitive Beliefs Questionnaire-Brief (MCQ-30)
Tidsramme: Change from baseline metacognition to metacognition after 6 months of MERIT
30 item measure of metacognition; each item is rated on a 1 to 4 scale with decreasing scores representing better metacognitive functioning.
Change from baseline metacognition to metacognition after 6 months of MERIT
The Positive and Negative Syndrome Scale (PANSS)
Tidsramme: Change from baseline symptoms to symptoms after 6 months of MERIT
30 item measure of symptoms; each item is rated 1 to 7, with greater scores representing more severe symptoms (and lower scores indicating better functioning)
Change from baseline symptoms to symptoms after 6 months of MERIT
EAR Adherence
Tidsramme: Average of EAR adherence from baseline and 6 month assessment sessions
Objective measure of how often EAR was worn; 0 (not worn) and 1 (worn) scores given at each of 48 potential time points. Total score represents frequency that the EAR is worn across all time points.
Average of EAR adherence from baseline and 6 month assessment sessions
EAR Experiential Questionnaire
Tidsramme: Average of EAR acceptability from baseline and 6 month assessment sessions
Assessment of how acceptable wearing the EAR was and how typical days were that EAR was worn. Scores for each item range from 1 to 5 with greater scores indicating greater problems (and lower acceptability).
Average of EAR acceptability from baseline and 6 month assessment sessions

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of Life Scale
Tidsramme: Change from baseline quality of life to quality of life after 6 months of MERIT
21 item measure of quality of life; each item is rated from 0 to 6, with greater scores indicating greater quality of life.
Change from baseline quality of life to quality of life after 6 months of MERIT
Metacognition Assessment Scale- Abbreviated (MAS-A)
Tidsramme: Change from baseline metacognitive capacity to metacognitive capacity after 6 months of MERIT
Clinician-rated measure of metacognition using a semi structured clinical interview; four areas of capacity are rated (0 to 28 on overall scale); for each, increasing scores represent greater capacity.
Change from baseline metacognitive capacity to metacognitive capacity after 6 months of MERIT
Short Form Health Survey (SF-36
Tidsramme: Change from baseline functioning to functioning after 6 months of MERIT
36 item measure of social functioning and general health behaviors; each item on a different scale but greater scores indicate better overall functioning.
Change from baseline functioning to functioning after 6 months of MERIT
Objective Behaviors from the Electronically Activated Recorder
Tidsramme: Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed)
EAR coding can be implemented to rate different forms of objective behaviors; codes generated using different scales but primarily use a 0 (not present) or 1 (present) coding scheme. Greater scores typically represent presence of that which is being coded.
Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed)
Scale to Assess Unawareness of Mental Disorder
Tidsramme: Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed)
Insight measure; three items rated on 1 to 5 scale, with increasing scores indicating poorer insight.
Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed)

Samarbejdspartnere og efterforskere

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

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 (Faktiske)

1. juli 2016

Primær færdiggørelse (Faktiske)

15. marts 2020

Studieafslutning (Faktiske)

15. marts 2020

Datoer for studieregistrering

Først indsendt

5. december 2020

Først indsendt, der opfyldte QC-kriterier

10. december 2020

Først opslået (Faktiske)

11. december 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. december 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. december 2020

Sidst verificeret

1. december 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • MERIT EAR Study

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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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 Standard MERIT

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