Effects of Integrated Moral Reasoning Development Intervention for Management of Violence in Schizophrenia
1 other identifier
interventional
43
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable schizophrenia
Started Sep 2019
Shorter than P25 for not_applicable schizophrenia
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedFirst Submitted
Initial submission to the registry
December 27, 2021
CompletedFirst Posted
Study publicly available on registry
January 26, 2022
CompletedJanuary 26, 2022
January 1, 2022
1.3 years
December 27, 2021
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)
EXPERIMENTALThe MRDI is comprised of 4 components that are run concurrently: moral reasoning, strategies of anger management and problem-solving and social skills.
the control group
NO INTERVENTIONThe 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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mei-Chi Hsu, Ph.D
I-Shou University
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