NCT05556941

Brief Summary

The overall aim of this study was to develop a meta-cognitive group intervention in order to apply it and to understand and distinguish the components that influence participation among people with schizophrenia

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable schizophrenia

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2016

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

September 22, 2022

Last Update Submit

September 29, 2022

Conditions

Keywords

Executive functionMeta-cognitionSchizophreniaMeta-cognitive intervention

Outcome Measures

Primary Outcomes (1)

  • Positive and Negative Syndrome Scale

    The Positive and Negative Syndrome Scale is a 30-item scale with seven positive and seven negative symptoms items and 16 psychopathological items. The severity of each item is rated on a scale from 1 (none) to 7 (most severe). A general Positive and Negative Syndrome Scale score is between 30 (lack of symptoms) and 210 (very severe state of the disease). Potential ranges are 7 to 49 for the positive and negative symptom scales and from 16 to 12 for the general psychopathology scale.

    15 minutes

Study Arms (2)

Metacognitive Group Intervention

EXPERIMENTAL

Meta cognitive intervention protocol based on the dynamic interactional model of cognition (Toglia, 2005), and specifically tailored to individuals with schizophrenia.

Behavioral: Metacognitive Group Intervention

Occupational therapy standard care

ACTIVE COMPARATOR

Standard care of occupational therapy in mental health, focused on work occupations.

Behavioral: Occupational therapy standard care

Interventions

The investigators developed an initial Meta cognitive group intervention protocol based on the dynamic interactional model of cognition (Toglia, 2005), and specifically tailored it to individuals with schizophrenia.

Metacognitive Group Intervention

Occupational therapy standard care

Occupational therapy standard care

Eligibility Criteria

Age23 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of schizophrenia by a licensed psychiatrist
  • Fluency in Hebrew
  • t-score of at least 65 on the Behavior Rating Inventory of Executive Function-Adult version

You may not qualify if:

  • Severe psychiatric hospitalization of over 24 hours during the month prior to the beginning of the study
  • Used drugs or alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Kaizerman-Dinerman A, Roe D, Josman N. An efficacy study of a metacognitive group intervention for people with schizophrenia. Psychiatry Res. 2018 Dec;270:1150-1156. doi: 10.1016/j.psychres.2018.10.037. Epub 2018 Oct 13.

  • Kaizerman-Dinerman A, Josman, Roe D. The use of cognitive strategies among people with schizophrenia: a randomized comparative study. The Open Journal of Occupational Therapy. 2019; 7(3): 1-12.

    RESULT
  • Kaizerman-Dinerman A, Roe D, Demeter N, Josman N. Do symptoms moderate the association between participation and executive functions outcomes among people with schizophrenia? BMC Psychiatry. 2023 Jan 17;23(1):42. doi: 10.1186/s12888-022-04510-0.

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Naomi Josman, PhD

    University of Haifa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Before and after intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

September 22, 2022

First Posted

September 27, 2022

Study Start

October 1, 2015

Primary Completion

April 30, 2016

Study Completion

April 30, 2016

Last Updated

October 3, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

In accordance with the Helsinki Declaration and University ethical committee principles, the data used in this study cannot be made available because it was not anonymous.