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
About this trial
This is an interventional treatment trial for Social Interaction
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
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
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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Personalizing Interventions Using Real-World Interactions
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