Metacognitive and Insight Therapy for Persons With Schizophrenia (RCT MERIT)
Primary Purpose
Diagnosis of Schizophrenia Spectrum Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
MERIT
Sponsored by
About this trial
This is an interventional supportive care trial for Diagnosis of Schizophrenia Spectrum Disorders focused on measuring Schizophrenia, Psychotherapy, Metacognitive abilities, Session by session assessment, Outcome
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of schizophrenia spectrum disorders
- Ability to provide informed consent
- Ability to read and write in Hebrew
Exclusion Criteria:
- No co-morbid nuerological condition
- No hospitalization in the last 6 months
Sites / Locations
- Bar-Ilan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
treatment group
delayed treatment control group
Arm Description
Outcomes
Primary Outcome Measures
Indiana Psychiatric Illness Interview
Interview
Positive and Negative Syndrome Scale
Clinician-rated scale
Social Skill Performance Assessment
Verbal role-play assessment
Face Emotion Identification Task
Questionnaire
Faux-Pas task
questionnaire
Ambiguous Intentions Hostility Questionnaire
Questionnaire
Heinrichs-Carpenter Quality of Life scale
Clinician-rated scale
Beck Depression Inventory-II
Questionnaire
Outcome Questionnaire -45
Questionnaire
The Life Regard Index
Questionnaire
The Internalized Stigma of Mental Illness scale
Questionnaire
Self-compassion Scale
Questionnaire
The Self-Concept Clarity scale
Questionnaire
Difficulties in Emotion Regulation Scale
Questionnaire
The Emotion Regulation Questionnaire
Questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT03427580
First Posted
February 4, 2018
Last Updated
July 19, 2021
Sponsor
Bar-Ilan University, Israel
1. Study Identification
Unique Protocol Identification Number
NCT03427580
Brief Title
Metacognitive and Insight Therapy for Persons With Schizophrenia (RCT MERIT)
Official Title
Metacognitive and Insight Therapy (MERIT) for Persons With Schizophrenia: Assessment of Session by Session Progress and Outcome.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bar-Ilan University, Israel
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
People with schizophrenia spectrum disorders are faced with significant metacognitive impairments that include difficulties in their ability to form complex representations of the self and others. These impairments are associated with increased symptoms, impaired subjective self-experiences, and lower social functioning. As a result, interventions that enhance metacognitive capacity have been recently developed and explored. One of these interventions is Metacognitive Reflection and Insight Therapy (MERIT; Lysaker et al., 2014). MERIT is an integrative model of psychotherapy that seeks to promote holistic metacognitive capacity and consequently increase a positive sense of agency and sense of meaning in life among clients with schizophrenia. Several case studies (including in Bar-Ilan's community clinic), as well as a recent pilot study, showed increased metacognitive abilities and a decrease in symptoms following MERIT. The current study will explore both the effectiveness and the change mechanisms that underlie MERIT interventon among clients diagnosed with schizophrenia spectrum disorders, via both pre- and post-measures of the intervention's outcome and session-by-session estimations of the therapeutic process.
**Till now (July 2019) 34 clients have been recruited: 7 clients completed the MERIT therapy; 12 clients are receiving MERIT therapy now days; 6 clients are on the waiting list; 9 dropouts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnosis of Schizophrenia Spectrum Disorders
Keywords
Schizophrenia, Psychotherapy, Metacognitive abilities, Session by session assessment, Outcome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Title
delayed treatment control group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
MERIT
Intervention Description
Metacognitive Reflection and Insight Therapy
Primary Outcome Measure Information:
Title
Indiana Psychiatric Illness Interview
Description
Interview
Time Frame
45 minutes
Title
Positive and Negative Syndrome Scale
Description
Clinician-rated scale
Time Frame
15 minutes
Title
Social Skill Performance Assessment
Description
Verbal role-play assessment
Time Frame
15 minutes
Title
Face Emotion Identification Task
Description
Questionnaire
Time Frame
5 minutes
Title
Faux-Pas task
Description
questionnaire
Time Frame
10 minutes
Title
Ambiguous Intentions Hostility Questionnaire
Description
Questionnaire
Time Frame
5 minutes
Title
Heinrichs-Carpenter Quality of Life scale
Description
Clinician-rated scale
Time Frame
30 minutes
Title
Beck Depression Inventory-II
Description
Questionnaire
Time Frame
5 minutes
Title
Outcome Questionnaire -45
Description
Questionnaire
Time Frame
5 minutes
Title
The Life Regard Index
Description
Questionnaire
Time Frame
5 minutes
Title
The Internalized Stigma of Mental Illness scale
Description
Questionnaire
Time Frame
5 minutes
Title
Self-compassion Scale
Description
Questionnaire
Time Frame
5 minutes
Title
The Self-Concept Clarity scale
Description
Questionnaire
Time Frame
5 minutes
Title
Difficulties in Emotion Regulation Scale
Description
Questionnaire
Time Frame
5 minutes
Title
The Emotion Regulation Questionnaire
Description
Questionnaire
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of schizophrenia spectrum disorders
Ability to provide informed consent
Ability to read and write in Hebrew
Exclusion Criteria:
No co-morbid nuerological condition
No hospitalization in the last 6 months
Facility Information:
Facility Name
Bar-Ilan University
City
Ramat Gan
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
32271073
Citation
Lavi-Rotenberg A, Bar-Kalifa E, de Jong S, Igra L, Lysaker PH, Hasson-Ohayon I. Elements that enhance therapeutic alliance and short-term outcomes in metacognitive reflection and insight therapy: A session-by-session assessment. Psychiatr Rehabil J. 2020 Dec;43(4):318-326. doi: 10.1037/prj0000415. Epub 2020 Apr 9.
Results Reference
derived
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Metacognitive and Insight Therapy for Persons With Schizophrenia (RCT MERIT)
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