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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05207319
Other study ID # IShouU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date December 31, 2020

Study information

Verified date January 2022
Source I-Shou University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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 (p < 0.05). In comparison with the treatment-as-usual group (n = 22), patients in the MRDI group (n = 21) showed improved levels of moral reasoning whereas decreased levels of violent behaviors. The MRDI participants also experienced significantly greater improvements or changes (p < 0.05) 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. The triggering point of violence is multi-faceted and dynamic. Many risk factors for violence intertwined and interacted at multiple levels. This integrated moral reasoning development intervention, when applied in conjunction with psychiatric standard care, could display synergistic and effective effects on moral reasoning and ethical evaluation, and impulsivity and personality features of repetitive violence in patients with schizophrenia. Suggestions for future research are made. There is a need to concurrently examine moral reasoning, violence and conflict handling styles in a dyadic context such as vSZ patients and their family members involved, so that a whole picture of the violence can be better observed.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: • Clinical diagnosis of catatonic schizophrenia and schizophreniform disorder.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
integrated Moral Reasoning Development Intervention (MRDI)
The MRDI is comprised of 4 components that are run concurrently: moral reasoning, strategies of anger management and problem-solving and social skills.

Locations

Country Name City State
Taiwan I-Shou University Kaohsiung City

Sponsors (1)

Lead Sponsor Collaborator
I-Shou University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary Modified Overt Aggression Scale Aggression Frequency Aggression frequency at Baseline
Primary 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)
Primary 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)
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