Personalizing Interventions Using Real-World Interactions

NCT04665401 | Completed

• 1 other identifier: MERIT EAR Study
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Social Interaction; Schizophrenia Spectrum and Other Psychotic Disorders

Outcome Measures

Primary Outcomes (5)

• Global Functioning Scale: Social (GFS)

  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)

  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)

  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

  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

  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

Secondary Outcomes (5)

• 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

• 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)

• Scale to Assess Unawareness of Mental Disorder

  Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed)

Study Arms (2)

Standard MERIT

ACTIVE COMPARATOR

24 sessions of Metacognition Reflection and Insight Therapy

Behavioral: Standard MERIT

Tailored MERIT

EXPERIMENTAL

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

Behavioral: Tailored MERIT

Interventions

Tailored MERIT BEHAVIORAL

see arm description

Tailored MERIT

Standard MERIT BEHAVIORAL

see arm description

Standard MERIT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 11, 2020
• Study Start: July 1, 2016
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share