Clinical trial NCT05207319: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Moral Status
Violence
Lead sponsor: I-Shou University
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 43
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: The Adapted Version of the Sociomoral Reflection Measure
timeFrame: Change of status of moral reasoning from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
measure: Multidimensional Ethics Scale
timeFrame: Change of ethical valuation from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
measure: Rational Experiential Inventory
timeFrame: Change of reasoning and thinking styles from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
measure: Rahim Organizational Conflict Inventory-II
timeFrame: Change of conflict management style from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
measure: Modified Overt Aggression Scale
timeFrame: Aggression frequency at Baseline
measure: Buss-Perry Aggression Questionnaire
timeFrame: Change of violence/aggression from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
measure: Ten Item Personality Inventory
timeFrame: Change of personality traits from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: I-Shou University
Study officials:
affiliation: I-Shou University
name: Mei-Chi Hsu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: