Clinical trial NCT04665401: 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
Overall status: COMPLETED
Phase: NA
Conditions: Social Interaction
Schizophrenia Spectrum and Other Psychotic Disorders
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Global Functioning Scale: Social (GFS)
timeFrame: Change from baseline social functioning to social functioning after 6 months of MERIT
measure: Metacognitive Beliefs Questionnaire-Brief (MCQ-30)
timeFrame: Change from baseline metacognition to metacognition after 6 months of MERIT
measure: The Positive and Negative Syndrome Scale (PANSS)
timeFrame: Change from baseline symptoms to symptoms after 6 months of MERIT
measure: EAR Adherence
timeFrame: Average of EAR adherence from baseline and 6 month assessment sessions
measure: EAR Experiential Questionnaire
timeFrame: Average of EAR acceptability from baseline and 6 month assessment sessions
Secondary outcomes:
measure: Quality of Life Scale
timeFrame: Change from baseline quality of life to quality of life after 6 months of MERIT
measure: Metacognition Assessment Scale- Abbreviated (MAS-A)
timeFrame: Change from baseline metacognitive capacity to metacognitive capacity after 6 months of MERIT
measure: Short Form Health Survey (SF-36
timeFrame: Change from baseline functioning to functioning after 6 months of MERIT
measure: Objective Behaviors from the Electronically Activated Recorder
timeFrame: Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed)
measure: Scale to Assess Unawareness of Mental Disorder
timeFrame: Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed)
Other outcomes:
Locations:
Study officials:
References: