Metacognitive and Insight Therapy for Persons With Schizophrenia (RCT MERIT)

• Sponsor: Bar-Ilan University, Israel (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03427580
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diagnosis of Schizophrenia Spectrum Disorders	Behavioral: MERIT	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Metacognitive and Insight Therapy (MERIT) for Persons With Schizophrenia: Assessment of Session by Session Progress and Outcome.
• Actual Study Start Date: Mar 1, 2018
• Actual Primary Completion Date: Mar 1, 2021
• Anticipated Study Completion Date: Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment group	Behavioral: MERIT; Metacognitive Reflection and Insight Therapy
Experimental: delayed treatment control group	Behavioral: MERIT; Metacognitive Reflection and Insight Therapy

Outcome Measures

Primary Outcome Measures

1. Indiana Psychiatric Illness Interview [45 minutes]

   Interview

2. Positive and Negative Syndrome Scale [15 minutes]

   Clinician-rated scale

3. Social Skill Performance Assessment [15 minutes]

   Verbal role-play assessment

4. Face Emotion Identification Task [5 minutes]

   Questionnaire

5. Faux-Pas task [10 minutes]

   questionnaire

6. Ambiguous Intentions Hostility Questionnaire [5 minutes]

   Questionnaire

7. Heinrichs-Carpenter Quality of Life scale [30 minutes]

   Clinician-rated scale

8. Beck Depression Inventory-II [5 minutes]

   Questionnaire

9. Outcome Questionnaire -45 [5 minutes]

   Questionnaire

10. The Life Regard Index [5 minutes]

    Questionnaire

11. The Internalized Stigma of Mental Illness scale [5 minutes]

    Questionnaire

12. Self-compassion Scale [5 minutes]

    Questionnaire

13. The Self-Concept Clarity scale [5 minutes]

    Questionnaire

14. Difficulties in Emotion Regulation Scale [5 minutes]

    Questionnaire

15. The Emotion Regulation Questionnaire [5 minutes]

    Questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bar-Ilan University	Ramat Gan		Israel

Sponsors and Collaborators

• Bar-Ilan University, Israel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ilanit Hasson-Ohayon, Prof. Ilanit Hasson-Ohayon, Principal Investigator, Bar-Ilan University, Israel
• ClinicalTrials.gov Identifier: NCT03427580
• Other Study ID Numbers: MERIT
• First Posted: Feb 9, 2018
• Last Update Posted: Jul 21, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ilanit Hasson-Ohayon, Prof. Ilanit Hasson-Ohayon, Principal Investigator, Bar-Ilan University, Israel: Schizophrenia; Psychotherapy; Metacognitive abilities; Session by session assessment; Outcome
• Additional relevant MeSH terms: Schizophrenia

Study Results

No Results Posted as of Jul 21, 2021