NCT05207319

Brief Summary

Moral cognition is an important and multidimensional, but often overlooked, determinant of violence. Very few interventions have systematically examined the role of moral reasoning, anger management and problem-solving together in violence. A randomized controlled trial was conducted to comprehensively evaluate the sustained effects of an integrated Moral Reasoning Development Intervention (MRDI) on management of repetitive violence in schizophrenia. This study placed special emphasis on essential components related to moral reasoning and violence in patients with schizophrenia. Evaluations including measures of violence, moral reasoning, ethical valuation and judgement, decision-making, conflict management style, and personality traits, were performed at baseline, end of intervention, and 1-month follow-up after intervention. MRDI was superior to treatment-as-usual in improving moral reasoning and related variables and violence outcomes. In comparison with the treatment-as-usual group, patients in the MRDI group showed improved levels of moral reasoning whereas decreased levels of violent behaviors. The MRDI participants also experienced significantly greater improvements or changes in their ethical valuation and judgement, decision-making style and preferences, and conflict management style. Our findings provide important implications for risk assessment and violence management and prevention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

1.3 years

First QC Date

December 27, 2021

Last Update Submit

January 13, 2022

Conditions

Outcome Measures

Primary Outcomes (7)

  • The Adapted Version of the Sociomoral Reflection Measure

    Moral reasoning (The score 1 which corresponds with the first stage of Kohlberg's moral development, indicates the patient did not understand the moral content of the proposition. )

    Change of status of moral reasoning from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)

  • Multidimensional Ethics Scale

    Ethical valuation (The patients are required to rate the questionable actions of a hypothetical auditor on several 7-point Likert scales, anchored on such as unjust/just, unfair/fair, unethical/ethical, not morally right/morally right, culturally unacceptable/culturally acceptable.)

    Change of ethical valuation from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)

  • Rational Experiential Inventory

    Reasoning and thinking styles (A higher score indicates a more rational/experiential thinking style.)

    Change of reasoning and thinking styles from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)

  • Rahim Organizational Conflict Inventory-II

    Conflict management style (The higher the score is, the greater a particular conflict management style is used.)

    Change of conflict management style from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)

  • Modified Overt Aggression Scale

    Aggression Frequency

    Aggression frequency at Baseline

  • Buss-Perry Aggression Questionnaire

    Violence/Aggression (The higher the score is, the higher the patient has the violent behavior.)

    Change of violence/aggression from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)

  • Ten Item Personality Inventory

    Personality traits (A greater change from the baseline in this scale (with higher score) on each of personality traits represents more the expression of each personality trait was calculated.)

    Change of personality traits from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)

Study Arms (2)

the MRDI group (Moral Reasoning Development Intervention)

EXPERIMENTAL

The MRDI is comprised of 4 components that are run concurrently: moral reasoning, strategies of anger management and problem-solving and social skills.

Other: integrated Moral Reasoning Development Intervention (MRDI)

the control group

NO INTERVENTION

The control group is the Treatment as Usual (TAU).

Interventions

The MRDI is comprised of 4 components that are run concurrently: moral reasoning, strategies of anger management and problem-solving and social skills.

the MRDI group (Moral Reasoning Development Intervention)

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of schizophrenia for more than 2 years
  • Psychiatrically hospitalized
  • Repetitive violence within one year
  • Having basic literacy
  • More than 20 years old
  • Less than 65 years old

You may not qualify if:

  • Clinical diagnosis of catatonic schizophrenia and schizophreniform disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

I-Shou University

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Mei-Chi Hsu, Ph.D

    I-Shou University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 27, 2021

First Posted

January 26, 2022

Study Start

September 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 26, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations