- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04665401
Personalizing Interventions Using Real-World Interactions
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
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
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
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MERIT EAR Study
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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