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Clinical Trials/NCT04665401
NCT04665401
Completed
Not Applicable

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

Indiana University0 sites34 target enrollmentJuly 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Social Interaction
Sponsor
Indiana University
Enrollment
34
Primary Endpoint
Global Functioning Scale: Social (GFS)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2016
End Date
March 15, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kyle S. Minor

Associate Professor

Indiana University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Global Functioning Scale: Social (GFS)

Time Frame: 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)

Metacognitive Beliefs Questionnaire-Brief (MCQ-30)

Time Frame: 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.

The Positive and Negative Syndrome Scale (PANSS)

Time Frame: 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)

EAR Adherence

Time Frame: 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.

EAR Experiential Questionnaire

Time Frame: 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).

Secondary Outcomes

  • Quality of Life Scale(Change from baseline quality of life to quality of life after 6 months of MERIT)
  • Metacognition Assessment Scale- Abbreviated (MAS-A)(Change from baseline metacognitive capacity to metacognitive capacity after 6 months of MERIT)
  • Scale to Assess Unawareness of Mental Disorder(Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed))
  • Short Form Health Survey (SF-36(Change from baseline functioning to functioning after 6 months of MERIT)
  • Objective Behaviors from the Electronically Activated Recorder(Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed))

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