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Personalizing Interventions Using Real-World Interactions

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Indiana University

Status

Completed

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders
Social Interaction

Treatments

Behavioral: Tailored MERIT
Behavioral: Standard MERIT

Study type

Interventional

Funder types

Other

Identifiers

NCT04665401
MERIT EAR Study

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

34 participants in 2 patient groups

Standard MERIT
Active Comparator group
Description:
24 sessions of Metacognition Reflection and Insight Therapy
Treatment:
Behavioral: Standard MERIT
Tailored MERIT
Experimental group
Description:
24 sessions of personalized Metacognition Reflection and Insight Therapy (sessions personalized using real-world interactions)
Treatment:
Behavioral: Tailored MERIT

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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