Trial Outcomes & Findings for Metacognitive and Insight Therapy for Persons With Schizophrenia (RCT MERIT) (NCT NCT03427580)
NCT ID: NCT03427580
Last Updated: 2025-03-06
Results Overview
The Metacognition Assessment Scale-Abbreviated (MAS-A) is a rating scale used to assess metacognitive abilities in individuals, particularly those with psychiatric conditions. The scale consists of four domains that reflect one's ability to understand different mental phenomena and use this understanding in order to cope with psychological challenges. Higher scores indicate a higher complexity of functions and ideas in each domain, i.e. higher values represent a better outcome. The four scales/domains: 1. self-reflectivity (min 1 to max 9) ; 2. understanding of the other's mind (min 1 to max 7) ; 3. decentration (min 1 to max 3) ; 4. mastery (min 1 to max 9). The total score is the sum of the ratings in each subscale. Thus, the total score can be ranged from 4 (min) to 28 (max), when higher values represent a better outcome.
COMPLETED
NA
54 participants
Prior to the begining of the therapy (baseline, pre-treatment), and again at the end of the therapy (six months later, post-treatment)
2025-03-06
Participant Flow
Participants were 35 adults diagnosed with of schizophrenia /schizoaffective disorder. Exclusion criteria: intellectual disability, neurological disorders, substance use problems, acute psychosis, and risk for suicidal behavior, based on the intake interview. The study used a delayed randomized controlled trial design to examine the therapeutic benefits of MERIT delivered in a community clinic at Bar-Ilan University.
Participant milestones
| Measure |
Treatment Group
MERIT: Metacognitive Reflection and Insight Therapy
|
Delayed Treatment Control Group
MERIT: Metacognitive Reflection and Insight Therapy
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
23
|
|
Overall Study
COMPLETED
|
21
|
14
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment Group
n=31 Participants
MERIT: Metacognitive Reflection and Insight Therapy
|
Delayed Treatment Control Group
n=23 Participants
MERIT: Metacognitive Reflection and Insight Therapy
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 10.63 • n=31 Participants
|
40.5 years
STANDARD_DEVIATION 8.71 • n=23 Participants
|
39.6 years
STANDARD_DEVIATION 9.74 • n=54 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=31 Participants
|
14 Participants
n=23 Participants
|
32 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=31 Participants
|
9 Participants
n=23 Participants
|
22 Participants
n=54 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Israel
|
21 participants
n=21 Participants • The number analyzed in row differs from overall due to dropouts.
|
14 participants
n=14 Participants • The number analyzed in row differs from overall due to dropouts.
|
35 participants
n=35 Participants • The number analyzed in row differs from overall due to dropouts.
|
PRIMARY outcome
Timeframe: Prior to the begining of the therapy (baseline, pre-treatment), and again at the end of the therapy (six months later, post-treatment)Population: The N in the "POST" row is following dropouts. Treatment Group Arm: Baseline/pre-treatment and post-treatment at 24 weeks; For Delayed Treatment Control Group Arm: Baseline/pre-waiting period and 6 months post-waiting period prior to starting treatment.
The Metacognition Assessment Scale-Abbreviated (MAS-A) is a rating scale used to assess metacognitive abilities in individuals, particularly those with psychiatric conditions. The scale consists of four domains that reflect one's ability to understand different mental phenomena and use this understanding in order to cope with psychological challenges. Higher scores indicate a higher complexity of functions and ideas in each domain, i.e. higher values represent a better outcome. The four scales/domains: 1. self-reflectivity (min 1 to max 9) ; 2. understanding of the other's mind (min 1 to max 7) ; 3. decentration (min 1 to max 3) ; 4. mastery (min 1 to max 9). The total score is the sum of the ratings in each subscale. Thus, the total score can be ranged from 4 (min) to 28 (max), when higher values represent a better outcome.
Outcome measures
| Measure |
Delayed Treatment Control Group
n=31 Participants
MERIT: Metacognitive Reflection and Insight Therapy
|
Treatment Group
n=23 Participants
MERIT: Metacognitive Reflection and Insight Therapy
|
|---|---|---|
|
Metacognition Assessment Scale-Abbreviated (MAS-A)
Post (treatment/waiting period)
|
14.22 score on a scale
Standard Deviation 3.4
|
14.25 score on a scale
Standard Deviation 4.2
|
|
Metacognition Assessment Scale-Abbreviated (MAS-A)
Pre (treatment/waiting period)
|
11.53 score on a scale
Standard Deviation 3.7
|
14.22 score on a scale
Standard Deviation 2.75
|
Adverse Events
Treatment Group
Delayed Treatment Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place