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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia Spectrum and Other Psychotic Disorders; Social Interaction
• Intervention / Treatment: Behavioral: Standard MERIT; Behavioral: Tailored MERIT

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard MERIT; 24 sessions of Metacognition Reflection and Insight Therapy	Behavioral: Standard MERIT; see arm description
Experimental: Tailored MERIT; 24 sessions of personalized Metacognition Reflection and Insight Therapy (sessions personalized using real-world interactions)	Behavioral: Tailored MERIT; see arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Scale	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)	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	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	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	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)

Collaborators and Investigators

• Sponsor: Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: December 5, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
• Other Study ID Numbers: MERIT EAR Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No