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Personalizing Interventions Using Real-World Interactions

NCT ID: NCT04665401

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2020-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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Social Interaction Schizophrenia Spectrum and Other Psychotic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard MERIT

24 sessions of Metacognition Reflection and Insight Therapy

Group Type ACTIVE_COMPARATOR

Standard MERIT

Intervention Type BEHAVIORAL

see arm description

Tailored MERIT

24 sessions of personalized Metacognition Reflection and Insight Therapy (sessions personalized using real-world interactions)

Group Type EXPERIMENTAL

Tailored MERIT

Intervention Type BEHAVIORAL

see arm description

Interventions

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Tailored MERIT

see arm description

Intervention Type BEHAVIORAL

Standard MERIT

see arm description

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Kyle S. Minor

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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MERIT EAR Study

Identifier Type: -

Identifier Source: org_study_id