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Personalizing Interventions Using Real-World Interactions

Primary Purpose

Social Interaction, Schizophrenia Spectrum and Other Psychotic Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tailored MERIT
Standard MERIT
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Interaction

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard MERIT

    Tailored MERIT

    Arm Description

    24 sessions of Metacognition Reflection and Insight Therapy

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

    Outcomes

    Primary Outcome Measures

    Global Functioning Scale: Social (GFS)
    10-point measure of social functioning (1 to 10, with increasing scores indicating greater social functioning)
    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.
    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)
    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.
    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).

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    Scale to Assess Unawareness of Mental Disorder
    Insight measure; three items rated on 1 to 5 scale, with increasing scores indicating poorer insight.

    Full Information

    First Posted
    December 5, 2020
    Last Updated
    December 10, 2020
    Sponsor
    Indiana University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04665401
    Brief Title
    Personalizing Interventions Using Real-World Interactions
    Official Title
    Personalizing Interventions Using Real-World Interactions: Improving Symptoms and Social Functioning in Schizophrenia With Tailored Metacognitive Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2016 (Actual)
    Primary Completion Date
    March 15, 2020 (Actual)
    Study Completion Date
    March 15, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Indiana University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Social Interaction, Schizophrenia Spectrum and Other Psychotic Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard MERIT
    Arm Type
    Active Comparator
    Arm Description
    24 sessions of Metacognition Reflection and Insight Therapy
    Arm Title
    Tailored MERIT
    Arm Type
    Experimental
    Arm Description
    24 sessions of personalized Metacognition Reflection and Insight Therapy (sessions personalized using real-world interactions)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Tailored MERIT
    Intervention Description
    see arm description
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard MERIT
    Intervention Description
    see arm description
    Primary Outcome Measure Information:
    Title
    Global Functioning Scale: Social (GFS)
    Description
    10-point measure of social functioning (1 to 10, with increasing scores indicating greater social functioning)
    Time Frame
    Change from baseline social functioning to social functioning after 6 months of MERIT
    Title
    Metacognitive Beliefs Questionnaire-Brief (MCQ-30)
    Description
    30 item measure of metacognition; each item is rated on a 1 to 4 scale with decreasing scores representing better metacognitive functioning.
    Time Frame
    Change from baseline metacognition to metacognition after 6 months of MERIT
    Title
    The Positive and Negative Syndrome Scale (PANSS)
    Description
    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)
    Time Frame
    Change from baseline symptoms to symptoms after 6 months of MERIT
    Title
    EAR Adherence
    Description
    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.
    Time Frame
    Average of EAR adherence from baseline and 6 month assessment sessions
    Title
    EAR Experiential Questionnaire
    Description
    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).
    Time Frame
    Average of EAR acceptability from baseline and 6 month assessment sessions
    Secondary Outcome Measure Information:
    Title
    Quality of Life Scale
    Description
    21 item measure of quality of life; each item is rated from 0 to 6, with greater scores indicating greater quality of life.
    Time Frame
    Change from baseline quality of life to quality of life after 6 months of MERIT
    Title
    Metacognition Assessment Scale- Abbreviated (MAS-A)
    Description
    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.
    Time Frame
    Change from baseline metacognitive capacity to metacognitive capacity after 6 months of MERIT
    Title
    Short Form Health Survey (SF-36
    Description
    36 item measure of social functioning and general health behaviors; each item on a different scale but greater scores indicate better overall functioning.
    Time Frame
    Change from baseline functioning to functioning after 6 months of MERIT
    Title
    Objective Behaviors from the Electronically Activated Recorder
    Description
    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.
    Time Frame
    Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed)
    Title
    Scale to Assess Unawareness of Mental Disorder
    Description
    Insight measure; three items rated on 1 to 5 scale, with increasing scores indicating poorer insight.
    Time Frame
    Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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