Effects of Integrated Moral Reasoning Development Intervention for Management of Violence in Schizophrenia
Primary Purpose
Schizophrenia, Moral Status, Violence
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
integrated Moral Reasoning Development Intervention (MRDI)
Sponsored by
About this trial
This is an interventional supportive care trial for Schizophrenia
Eligibility Criteria
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.
Sites / Locations
- I-Shou University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
the MRDI group (Moral Reasoning Development Intervention)
the control group
Arm Description
The 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 is the Treatment as Usual (TAU).
Outcomes
Primary Outcome Measures
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. )
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.)
Rational Experiential Inventory
Reasoning and thinking styles (A higher score indicates a more rational/experiential thinking style.)
Rahim Organizational Conflict Inventory-II
Conflict management style (The higher the score is, the greater a particular conflict management style is used.)
Modified Overt Aggression Scale
Aggression Frequency
Buss-Perry Aggression Questionnaire
Violence/Aggression (The higher the score is, the higher the patient has the violent behavior.)
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.)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05207319
Brief Title
Effects of Integrated Moral Reasoning Development Intervention for Management of Violence in Schizophrenia
Official Title
Effects of Integrated Moral Reasoning Development Intervention for Management of Violence in Schizophrenia: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I-Shou University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Moral Status, Violence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the MRDI group (Moral Reasoning Development Intervention)
Arm Type
Experimental
Arm Description
The MRDI is comprised of 4 components that are run concurrently: moral reasoning, strategies of anger management and problem-solving and social skills.
Arm Title
the control group
Arm Type
No Intervention
Arm Description
The control group is the Treatment as Usual (TAU).
Intervention Type
Other
Intervention Name(s)
integrated Moral Reasoning Development Intervention (MRDI)
Intervention Description
The MRDI is comprised of 4 components that are run concurrently: moral reasoning, strategies of anger management and problem-solving and social skills.
Primary Outcome Measure Information:
Title
The Adapted Version of the Sociomoral Reflection Measure
Description
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. )
Time Frame
Change of status of moral reasoning from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
Title
Multidimensional Ethics Scale
Description
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.)
Time Frame
Change of ethical valuation from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
Title
Rational Experiential Inventory
Description
Reasoning and thinking styles (A higher score indicates a more rational/experiential thinking style.)
Time Frame
Change of reasoning and thinking styles from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
Title
Rahim Organizational Conflict Inventory-II
Description
Conflict management style (The higher the score is, the greater a particular conflict management style is used.)
Time Frame
Change of conflict management style from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
Title
Modified Overt Aggression Scale
Description
Aggression Frequency
Time Frame
Aggression frequency at Baseline
Title
Buss-Perry Aggression Questionnaire
Description
Violence/Aggression (The higher the score is, the higher the patient has the violent behavior.)
Time Frame
Change of violence/aggression from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
Title
Ten Item Personality Inventory
Description
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.)
Time Frame
Change of personality traits from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei-Chi Hsu, Ph.D
Organizational Affiliation
I-Shou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
I-Shou University
City
Kaohsiung City
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Integrated Moral Reasoning Development Intervention for Management of Violence in Schizophrenia
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