Schizophenia DisorderNCT07183982
Multidisciplinary Rehabilitation Program for Treatment-Resistant Psychotic Forensic Patients: A Comparative Study
A study testing MoCA: Montreal Cognitive Assessment (MoCA) and Positive and Negative Syndrome Scale (PANSS) and Rehabilitation program in the form of : psychodynamic group therapy, music and art therapy , cognitive stimulation techniques in people with Schizophenia Disorder and Forensic Psychiatric Patients, run by Oman Ministry of Health at 1 site in Oman.
Trial summary
This study employs a quasi-experimental design to evaluate the effectiveness of a 6-month multidisciplinary rehabilitation program integrating psychodynamic group therapy, art therapy, music therapy, and cognitive stimulation compared to standard rehabilitation (physiotherapy and occupational therapy). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Schizophenia Disorder, Forensic Psychiatric Patients
- What is being tested?
- MoCA: Montreal Cognitive Assessment (MoCA) and Positive and Negative Syndrome Scale (PANSS) and Rehabilitation program in the form of : psychodynamic group therapy, music and art therapy , cognitive stimulation techniques
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteOman
- Study dates
- 10 Jul 2025to 1 Aug 2025
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic psychotic disorder (e.g., schizophrenia or schizoaffective disorder) confirmed by psychiatric assessment and medical records.
- Presence of residual psychotic symptoms (positive symptoms such as hallucinations, delusions; and/or negative symptoms such as blunted affect, social withdrawal) despite ongoing psychotropic treatment.
- Medically stable and deemed suitable for participation by the treating psychiatrist or healthcare team.
- Patients who provide informed consent to participate in the rehabilitation program and research study.
Who cannot join
- Acute medical or psychiatric conditions requiring immediate intervention.
- Developmental or intellectual disabilities that significantly impair participation in the rehabilitation program or assessments.
- Current substance dependence that would interfere with participation.
- Significant risk of harm to self or others, based on clinical assessment or history of violence/aggression.
- Contraindications to specific rehabilitation program components (e.g., physical exercise, group activities) as determined by medical evaluation.
- Inability to comprehend study requirements or provide informed consent due to language barriers, cognitive impairment, or other factors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Multidisciplinary Rehabilitation Program for Treatment-Resistant Psychotic Patients in a Forensic Psychiatric Setting: A Comparative Study
This study employs a quasi-experimental design to evaluate the effectiveness of a 6-month multidisciplinary rehabilitation program integrating psychodynamic group therapy, art therapy, music therapy, and cognitive stimulation compared to standard rehabilitation (physiotherapy and occupational therapy). It will be done between a group of a total of 20 patients are divided into an intervention group and a control group from the forensic psychiatric department in Al Masarra Hospital.
Read the detailed description
Forensic psychiatric patients with treatment-resistant psychotic symptoms often experience persistent cognitive, functional, and social deficits, posing significant challenges to rehabilitation. Traditional approaches may not adequately address these complex needs, highlighting the importance of innovative, multidisciplinary interventions. This study employs a quasi-experimental design to evaluate the effectiveness of a 6-month multidisciplinary rehabilitation program integrating psychodynamic group therapy, art therapy, music therapy, and cognitive stimulation compared to standard rehabilitation (physiotherapy and occupational therapy). A total of 20 patients are divided into an intervention group (n=10) and a control group (n=10) using convenience sampling from the forensic psychiatric department in Al Masarra Hospital. Data is collected using the Positive and Negative Syndrome Scale (PANSS) to assess psychotic symptoms and the Montreal Cognitive Assessment (MoCA) to evaluate cognitive function, administered at baseline and post-intervention. Data is analyzed using descriptive statistics (median, interquartile range) and non-parametric tests, including the Wilcoxon Signed-Rank Test for within-group comparisons and the Mann-Whitney U Test for between-group comparisons. Effect sizes are calculated using Cliff's Delta to assess the practical significance of the findings. The null hypothesis states that there will be no significant difference in PANSS and MoCA scores between the intervention and control groups post-intervention. If the null hypothesis is rejected, the findings will provide evidence for integrating creative and psychotherapeutic interventions into forensic psychiatric rehabilitation, offering a scalable model for similar settings.
- Being tested
- MoCA: Montreal Cognitive Assessment (MoCA) and Positive and Negative Syndrome Scale (PANSS), Rehabilitation program in the form of : psychodynamic group therapy, music and art therapy , cognitive stimulation techniques
- Keywords
- Rehabilitation, Resistant Schizophrenia, Forensic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoCA: Montreal Cognitive Assessment (MoCA) and Positive and Negative Syndrome Scale (PANSS)Diagnostic test
MoCA: A 30-point screening tool assessing attention, memory, language, visuospatial and executive functions; quick and sensitive to mild cognitive deficits.
PANSS: A 30-item scale rating positive, negative, and general psychopathology symptoms in psychotic disorders; widely used to track severity and change.
Rehabilitation program in the form of : psychodynamic group therapy, music and art therapy , cognitive stimulation techniquesBehavioural
Participants received a structured 6-month program designed to address persistent psychotic symptoms and associated deficits. The intervention included:
Art Therapy: Weekly sessions promoting self-expression, emotional regulation, and enhancement of social interaction.
Cognitive Stimulation: Structured group exercises aimed at improving attention, memory, executive functions, and problem-solving.
The program was delivered by a multidisciplinary team in a group of 10 patients, ensuring active participation, individualized support, and integration of therapeutic modalities.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Multidisciplinary Rehabilitation Arm | Experimental | 10 forensic psychiatric patients selected via convenience sampling from the forensic department of Al Masarra Hospital. All participants are diagnosed with treatment-resistant psychotic disorders and exhibit persistent cognitive, social, and functional deficits despite receiving pharmacological treatment. The patients included in this group match the inclusion criteria.
This group is enrolled in a 6-month structured multidisciplinary rehabilitation program that integrates four distinct therapeutic modalities, each targeting a different domain of recovery: psychodynamic group therapy, art therapy, music therapy, and cognitive stimulation beside the tradition rehabilitation done (physiotherapy and occupational therapy. The integration of these therapies is designed to address the residual psychotic symptoms, cognitive, functional, emotional and relational impairments of the patients with resistant psychotic symptoms, which are often neglected in standard rehabilitation approaches. Receives: Diagnostic Test: MoCA: Montreal Cognitive Assessment (MoCA) and Positive and Negative Syndrome Scale (PANSS); Behavioral: Rehabilitation program in the form of : psychodynamic group therapy, music and art therapy , cognitive stimulation techniques |
| Control Group: Standard Rehabilitation Arm | Experimental | The control group consists of another 10 forensic psychiatric patients selected from the same department using the same inclusion criteria and sampling method. These patients are also diagnosed with treatment-resistant psychotic disorders and have longstanding impairments in cognition, functioning, and social interaction. However, instead of receiving the enhanced multidisciplinary program, they participate in the existing standard rehabilitation services provided at Al Masarra Hospital. This group serves as the comparison arm (control group) in this comparative experimental study.
The standard rehabilitation program primarily includes physiotherapy and occupational therapy, both of which are routinely available within the hospital's forensic unit. These therapies aim to maintain physical health and promote basic functional independence in hospitalized patients with severe mental illness. Receives: Diagnostic Test: MoCA: Montreal Cognitive Assessment (MoCA) and Positive and Negative Syndrome Scale (PANSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psychotic Symptoms Measured by the Positive and Negative Syndrome Scale (PANSS)
Psychotic symptom severity will be assessed using the Positive and Negative Syndrome Scale (PANSS). Scores range from 30 to 210, with higher scores indicating greater severity. The unit of measure is score change from baseline to post-intervention.
Measured: Baseline (pre-intervention) and 6 months (post-intervention).
Secondary outcomes (1)
Change in Cognitive Function Measured by the Montreal Cognitive Assessment (MoCA) scale
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA) scale. Scores range from 0 to 30, with higher scores indicating better cognitive performance. The unit of measure is score change from baseline to post-intervention.
Measured: Baseline (pre-intervention) and 6 months (post intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start10 Jul 2025
- Primary completion10 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophenia DisorderStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This quasi-experimental, non-randomized parallel-group study evaluates a 6-month multidisciplinary rehabilitation program for forensic psychiatric inpatients with treatment-resistant psychotic symptoms at Al Masarra Hospital. Twenty patients will be allocated by convenience sampling to an intervention group (n=10) or control group (n=10). The intervention integrates psychodynamic group therapy, art therapy, music therapy, and cognitive stimulation (4-5 hrs/week), while controls receive standard physiotherapy and occupational therapy (3-4 hrs/week). PANSS and MoCA will be administered at baseline and post-intervention by blinded assessors. Data will be analyzed using Wilcoxon Signed-Rank and Mann-Whitney U tests, with effect sizes reported via Cliff's Delta. The null hypothesis is that there will be no significant differences in psychotic symptoms or cognition between groups post-intervention. outcomes may support rehabilitation importance in forensic settings.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oman Ministry of Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sara Habib, Oman Ministry of Health
- Investigators
- Sara A. Habib, Specialist, Principal investigator, Al Massara Hospital,MOH Oman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183982
- Sponsor's protocol ID
- MoH/CSR/24/28654
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multidisciplinary Rehabilitation Program for Treatment-Resistant Psychotic Patients in a Forensic Psychiatric Setting: A Comparative Study
- ClinicalTrials.gov ID
- NCT07183982
- Acronym / sponsor ID
- MoH/CSR/24/28654
- Keywords
- Rehabilitation, Resistant Schizophrenia, Forensic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oman Ministry of HealthOther government
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 19 Sep 2025 (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.
This study employs a quasi-experimental design to evaluate the effectiveness of a 6-month multidisciplinary rehabilitation program integrating psychodynamic group therapy, art therapy, music therapy, and cognitive stimulation compared to standard rehabilitation (physiotherapy and occupational therapy). It will be done between a group of a total of 20 patients are divided into an intervention group and a control group from the forensic psychiatric department in Al Masarra Hospital.
Detailed description
Forensic psychiatric patients with treatment-resistant psychotic symptoms often experience persistent cognitive, functional, and social deficits, posing significant challenges to rehabilitation. Traditional approaches may not adequately address these complex needs, highlighting the importance of innovative, multidisciplinary interventions. This study employs a quasi-experimental design to evaluate the effectiveness of a 6-month multidisciplinary rehabilitation program integrating psychodynamic group therapy, art therapy, music therapy, and cognitive stimulation compared to standard rehabilitation (physiotherapy and occupational therapy). A total of 20 patients are divided into an intervention group (n=10) and a control group (n=10) using convenience sampling from the forensic psychiatric department in Al Masarra Hospital. Data is collected using the Positive and Negative Syndrome Scale (PANSS) to assess psychotic symptoms and the Montreal Cognitive Assessment (MoCA) to evaluate cognitive function, administered at baseline and post-intervention. Data is analyzed using descriptive statistics (median, interquartile range) and non-parametric tests, including the Wilcoxon Signed-Rank Test for within-group comparisons and the Mann-Whitney U Test for between-group comparisons. Effect sizes are calculated using Cliff's Delta to assess the practical significance of the findings. The null hypothesis states that there will be no significant difference in PANSS and MoCA scores between the intervention and control groups post-intervention. If the null hypothesis is rejected, the findings will provide evidence for integrating creative and psychotherapeutic interventions into forensic psychiatric rehabilitation, offering a scalable model for similar settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This quasi-experimental, non-randomized parallel-group study evaluates a 6-month multidisciplinary rehabilitation program for forensic psychiatric inpatients with treatment-resistant psychotic symptoms at Al Masarra Hospital. Twenty patients will be allocated by convenience sampling to an intervention group (n=10) or control group (n=10). The intervention integrates psychodynamic group therapy, art therapy, music therapy, and cognitive stimulation (4-5 hrs/week), while controls receive standard physiotherapy and occupational therapy (3-4 hrs/week). PANSS and MoCA will be administered at baseline and post-intervention by blinded assessors. Data will be analyzed using Wilcoxon Signed-Rank and Mann-Whitney U tests, with effect sizes reported via Cliff's Delta. The null hypothesis is that there will be no significant differences in psychotic symptoms or cognition between groups post-intervention. outcomes may support rehabilitation importance in forensic settings.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Multidisciplinary Rehabilitation Arm | Experimental | Diagnostic Test: MoCA: Montreal Cognitive Assessment (MoCA) and Positive and Negative Syndrome Scale (PANSS), Behavioral: Rehabilitation program in the form of : psychodynamic group therapy, music and art therapy , cognitive stimulation techniques10 forensic psychiatric patients selected via convenience sampling from the forensic department of Al Masarra Hospital. All participants are diagnosed with treatment-resistant psychotic disorders and exhibit persistent cognitive, social, and functional deficits despite receiving pharmacological treatment. The patients included in this group match the inclusion criteria. This group is enrolled in a 6-month structured multidisciplinary rehabilitation program that integrates four distinct therapeutic modalities, each targeting a different domain of recovery: psychodynamic group therapy, art therapy, music therapy, and cognitive stimulation beside the tradition rehabilitation done (physiotherapy and occupational therapy. The integration of these therapies is designed to address the residual psychotic symptoms, cognitive, functional, emotional and relational impairments of the patients with resistant psychotic symptoms, which are often neglected in standard rehabilitation approaches. |
| Control Group: Standard Rehabilitation Arm | Experimental | Diagnostic Test: MoCA: Montreal Cognitive Assessment (MoCA) and Positive and Negative Syndrome Scale (PANSS)The control group consists of another 10 forensic psychiatric patients selected from the same department using the same inclusion criteria and sampling method. These patients are also diagnosed with treatment-resistant psychotic disorders and have longstanding impairments in cognition, functioning, and social interaction. However, instead of receiving the enhanced multidisciplinary program, they participate in the existing standard rehabilitation services provided at Al Masarra Hospital. This group serves as the comparison arm (control group) in this comparative experimental study. The standard rehabilitation program primarily includes physiotherapy and occupational therapy, both of which are routinely available within the hospital's forensic unit. These therapies aim to maintain physical health and promote basic functional independence in hospitalized patients with severe mental illness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of chronic psychotic disorder (e.g., schizophrenia or schizoaffective disorder) confirmed by psychiatric assessment and medical records.
- Presence of residual psychotic symptoms (positive symptoms such as hallucinations, delusions; and/or negative symptoms such as blunted affect, social withdrawal) despite ongoing psychotropic treatment.
- Medically stable and deemed suitable for participation by the treating psychiatrist or healthcare team.
- Patients who provide informed consent to participate in the rehabilitation program and research study.
Key exclusion criteria (6 listed)
- Acute medical or psychiatric conditions requiring immediate intervention.
- Developmental or intellectual disabilities that significantly impair participation in the rehabilitation program or assessments.
- Current substance dependence that would interfere with participation.
- Significant risk of harm to self or others, based on clinical assessment or history of violence/aggression.
- Contraindications to specific rehabilitation program components (e.g., physical exercise, group activities) as determined by medical evaluation.
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 |
|---|---|---|
| MoCA: Montreal Cognitive Assessment (MoCA) and Positive and Negative Syndrome Scale (PANSS)MoCA: A 30-point screening tool assessing attention, memory, language, visuospatial and executive functions; quick and sensitive to mild cognitive deficits. PANSS: A 30-item scale rating positive, negative, and general psychopathology symptoms in psychotic disorders; widely used to track severity and change. | Diagnostic test | Control Group: Standard Rehabilitation Arm, Intervention Group: Multidisciplinary Rehabilitation Arm |
| Rehabilitation program in the form of : psychodynamic group therapy, music and art therapy , cognitive stimulation techniquesParticipants received a structured 6-month program designed to address persistent psychotic symptoms and associated deficits. The intervention included: Art Therapy: Weekly sessions promoting self-expression, emotional regulation, and enhancement of social interaction. Cognitive Stimulation: Structured group exercises aimed at improving attention, memory, executive functions, and problem-solving. The program was delivered by a multidisciplinary team in a group of 10 patients, ensuring active participation, individualized support, and integration of therapeutic modalities. | Behavioural | Intervention Group: Multidisciplinary Rehabilitation Arm |
Primary outcome
Change in Psychotic Symptoms Measured by the Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline (pre-intervention) and 6 months (post-intervention).
Psychotic symptom severity will be assessed using the Positive and Negative Syndrome Scale (PANSS). Scores range from 30 to 210, with higher scores indicating greater severity. The unit of measure is score change from baseline to post-intervention.
1 secondary outcome
Change in Cognitive Function Measured by the Montreal Cognitive Assessment (MoCA) scale
Time frame: Baseline (pre-intervention) and 6 months (post intervention).
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 19 Sep 2025.
Related trials for Schizophenia Disorder
Not yet recruiting
Effect of Occupational Therapy on Psychosocial Parameters and Functioning in Individuals With Severe Mental Illness
Schizophenia Disorder, Severe Mental Illness
Not yet recruiting
Motivational Intervention for Patients With Schizophrenia
Schizo-affective Disorder, Non Organic Psychosis
RecruitingPhase 4
Biomarkers to Enhance Early Schizophrenia Treatment
Schizophenia Disorder
Active, not recruitingObservational study
Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections: Translating Epidemiology to Deep-phenotyping.
Anxiety, Depression - Major Depressive Disorder
RecruitingPhase 4
Exercise and Olanzapine-samidorphan
Schizophenia Disorder, Schizoaffective Disorder
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.
Sara A. Habib, Specialist principal investigator
Al Massara Hospital,MOH Oman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MoCA: Montreal Cognitive Assessment (MoCA) and Positive and Negative Syndrome Scale (PANSS) and Rehabilitation program in the form of : psychodynamic group therapy, music and art therapy , cognitive stimulation techniques in people with Schizophenia Disorder and Forensic Psychiatric Patients, run by Oman Ministry of Health at 1 site in Oman.
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 4 inclusion and 6 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 19 Sep 2025. 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 Oman. 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?
Change in Psychotic Symptoms Measured by the Positive and Negative Syndrome Scale (PANSS) (time frame: Baseline (pre-intervention) and 6 months (post-intervention).). 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 19 Sep 2025.