Personalizing Interventions Using Real-World Interactions

• ClinicalTrials.gov Identifier: NCT04665401
• Recruitment Status: Completed
• First Posted: December 11, 2020
• Last Update Posted: December 11, 2020
• Sponsor: Indiana University
• Information provided by (Responsible Party): Kyle S. Minor, Indiana University

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.

Condition or disease	Intervention/treatment	Phase
Social Interaction; Schizophrenia Spectrum and Other Psychotic Disorders	Behavioral: Tailored MERIT; Behavioral: Standard MERIT	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Personalizing Interventions Using Real-World Interactions: Improving Symptoms and Social Functioning in Schizophrenia With Tailored Metacognitive Therapy
• Actual Study Start Date: July 1, 2016
• Actual Primary Completion Date: March 15, 2020
• Actual Study Completion Date: March 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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)
2. 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.
3. 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)
4. 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.
5. 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 Outcome Measures :

1. Quality of Life Scale [ Time Frame: Change from baseline quality of life to quality of life after 6 months of MERIT ]
   21 item measure of quality of life; each item is rated from 0 to 6, with greater scores indicating greater quality of life.
2. Metacognition Assessment Scale- Abbreviated (MAS-A) [ Time Frame: Change from baseline metacognitive capacity to metacognitive capacity after 6 months of MERIT ]
   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.
3. Short Form Health Survey (SF-36 [ Time Frame: Change from baseline functioning to functioning after 6 months of MERIT ]
   36 item measure of social functioning and general health behaviors; each item on a different scale but greater scores indicate better overall functioning.
4. Objective Behaviors from the Electronically Activated Recorder [ Time Frame: Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed) ]
   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.
5. Scale to Assess Unawareness of Mental Disorder [ Time Frame: Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed) ]
   Insight measure; three items rated on 1 to 5 scale, with increasing scores indicating poorer insight.

Eligibility Criteria

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

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Kyle S. Minor, Associate Professor, Indiana University
• ClinicalTrials.gov Identifier: NCT04665401
• Other Study ID Numbers: MERIT EAR Study
• First Posted: December 11, 2020
• Last Update Posted: December 11, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Schizophrenia; Mental Disorders; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders