Social InteractionNCT04665401
Personalizing Interventions Using Real-World Interactions
A study testing Tailored MERIT and Standard MERIT in people with Social Interaction and Schizophrenia Spectrum and Other Psychotic Disorders, run by Indiana University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Social Interaction, Schizophrenia Spectrum and Other Psychotic Disorders
- What is being tested?
- Tailored MERIT and Standard MERIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Positive screen for metacognitive dysfunction
- Serious Mental Illness diagnosis (schizophrenia-spectrum)
- Age 18-60
- English fluency
- Currently in non-acute phase of illness
Who cannot join
- Inability to provide informed consent
- Current substance dependence
- Documented intellectual disability
About this study
Official title: 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.
- Being tested
- Tailored MERIT, Standard MERIT
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored MERITBehavioural
see arm description
Standard MERITBehavioural
see arm description
| Study group | Role | What they receive |
|---|---|---|
| Standard MERIT | Active comparator | 24 sessions of Metacognition Reflection and Insight Therapy Receives: Behavioral: Standard MERIT |
| Tailored MERIT | Experimental | 24 sessions of personalized Metacognition Reflection and Insight Therapy (sessions personalized using real-world interactions) Receives: Behavioral: Tailored MERIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Functioning Scale: Social (GFS)
10-point measure of social functioning (1 to 10, with increasing scores indicating greater social functioning)
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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).
Measured: Average of EAR acceptability from baseline and 6 month assessment sessions
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Jul 2016
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle S. Minor, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665401
- Sponsor's protocol ID
- MERIT EAR Study
- Status last verified
- Dec 2020
- First submitted
- 5 Dec 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalizing Interventions Using Real-World Interactions: Improving Symptoms and Social Functioning in Schizophrenia With Tailored Metacognitive Therapy
- ClinicalTrials.gov ID
- NCT04665401
- Acronym / sponsor ID
- MERIT EAR Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard MERIT | Active comparator | Behavioral: Standard MERIT24 sessions of Metacognition Reflection and Insight Therapy |
| Tailored MERIT | Experimental | Behavioral: Tailored MERIT24 sessions of personalized Metacognition Reflection and Insight Therapy (sessions personalized using real-world interactions) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Positive screen for metacognitive dysfunction
- Serious Mental Illness diagnosis (schizophrenia-spectrum)
- Age 18-60
- English fluency
- Currently in non-acute phase of illness
Key exclusion criteria (3 listed)
- Inability to provide informed consent
- Current substance dependence
- Documented intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored MERITsee arm description | Behavioural | Tailored MERIT |
| Standard MERITsee arm description | Behavioural | Standard MERIT |
Primary outcome
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)
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.
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)
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.
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).
5 secondary outcomes
Quality of Life Scale
Time frame: Change from baseline quality of life to quality of life after 6 months of MERIT
Metacognition Assessment Scale- Abbreviated (MAS-A)
Time frame: Change from baseline metacognitive capacity to metacognitive capacity after 6 months of MERIT
Short Form Health Survey (SF-36
Time frame: Change from baseline functioning to functioning after 6 months of MERIT
Objective Behaviors from the Electronically Activated Recorder
Time frame: Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed)
Scale to Assess Unawareness of Mental Disorder
Time frame: Baseline, 3 months into MERIT, 6 months into MERIT (MERIT completed)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored MERIT and Standard MERIT in people with Social Interaction and Schizophrenia Spectrum and Other Psychotic Disorders, run by Indiana University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Functioning Scale: Social (GFS) (time frame: Change from baseline social functioning to social functioning after 6 months of MERIT). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.