SchizophreniaNCT05207319
Effects of Integrated Moral Reasoning Development Intervention for Management of Violence in Schizophrenia
A study testing integrated Moral Reasoning Development Intervention (MRDI) in people with Schizophrenia and Moral Status, run by I-Shou University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia, Moral Status, Violence
- What is being tested?
- integrated Moral Reasoning Development Intervention (MRDI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Clinical diagnosis of catatonic schizophrenia and schizophreniform disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Integrated Moral Reasoning Development Intervention for Management of Violence in Schizophrenia: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Schizophrenia, Moral Status, Violence
- Being tested
- integrated Moral Reasoning Development Intervention (MRDI)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated Moral Reasoning Development Intervention (MRDI)Other
The MRDI is comprised of 4 components that are run concurrently: moral reasoning, strategies of anger management and problem-solving and social skills.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: integrated Moral Reasoning Development Intervention (MRDI) |
| the control group | No intervention | The control group is the Treatment as Usual (TAU). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. )
Measured: 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.)
Measured: 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.)
Measured: 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.)
Measured: 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
Measured: Aggression frequency at Baseline
Buss-Perry Aggression Questionnaire
Violence/Aggression (The higher the score is, the higher the patient has the violent behavior.)
Measured: 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.)
Measured: Change of personality traits from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Sep 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- I-Shou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei-Chi Hsu, I-Shou University
- Investigators
- Mei-Chi Hsu, Ph.D, Principal investigator, I-Shou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207319
- Sponsor's protocol ID
- IShouU
- Status last verified
- Jan 2022
- First submitted
- 27 Dec 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Integrated Moral Reasoning Development Intervention for Management of Violence in Schizophrenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05207319
- Acronym / sponsor ID
- IShouU
- Conditions
- Schizophrenia, Moral Status, Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- I-Shou UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the MRDI group (Moral Reasoning Development Intervention) | Experimental | 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. |
| the control group | No intervention | –The control group is the Treatment as Usual (TAU). |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of schizophrenia for more than 2 years
- Psychiatrically hospitalized
- Repetitive violence within one year
- Having basic literacy
- More than 20 years old
Key exclusion criteria (1 listed)
- Clinical diagnosis of catatonic schizophrenia and schizophreniform disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | the MRDI group (Moral Reasoning Development Intervention) |
Primary outcome
The Adapted Version of the Sociomoral Reflection Measure
Time frame: Change of status of moral reasoning from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
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
Time frame: Change of ethical valuation from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
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
Time frame: Change of reasoning and thinking styles from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
Reasoning and thinking styles (A higher score indicates a more rational/experiential thinking style.)
Rahim Organizational Conflict Inventory-II
Time frame: Change of conflict management style from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
Conflict management style (The higher the score is, the greater a particular conflict management style is used.)
Modified Overt Aggression Scale
Time frame: Aggression frequency at Baseline
Aggression Frequency
Buss-Perry Aggression Questionnaire
Time frame: Change of violence/aggression from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
Violence/Aggression (The higher the score is, the higher the patient has the violent behavior.)
Ten Item Personality Inventory
Time frame: Change of personality traits from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)
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.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-Chi Hsu, Ph.D principal investigator
I-Shou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing integrated Moral Reasoning Development Intervention (MRDI) in people with Schizophrenia and Moral Status, run by I-Shou University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Adapted Version of the Sociomoral Reflection Measure (time frame: Change of status of moral reasoning from Baseline (T1), immediately after the intervention (T2), to 1-month follow-up after intervention (T3)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.