Multidisciplinary Rehabilitation Program for Treatment-Resistant Psychotic Forensic Patients: A Comparative Study

NCT ID: NCT07183982

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-10
• Study Completion Date: 2025-08-01

Brief 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). 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.

Conditions

Schizophenia Disorder; Forensic Psychiatric Patients

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group: Multidisciplinary Rehabilitation Arm

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.

Group Type: EXPERIMENTAL

MoCA: Montreal Cognitive Assessment (MoCA) and Positive and Negative Syndrome Scale (PANSS)

Intervention Type: 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 techniques

Intervention Type: BEHAVIORAL

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.

Control Group: Standard Rehabilitation Arm

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.

Group Type: EXPERIMENTAL

MoCA: Montreal Cognitive Assessment (MoCA) and Positive and Negative Syndrome Scale (PANSS)

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Rehabilitation program in the form of : psychodynamic group therapy, music and art therapy , cognitive stimulation techniques

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of chronic psychotic disorder (e.g., schizophrenia or schizoaffective disorder) confirmed by psychiatric assessment and medical records.

2. 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.

3. Medically stable and deemed suitable for participation by the treating psychiatrist or healthcare team.

4. Patients who provide informed consent to participate in the rehabilitation program and research study.

Exclusion Criteria

1. Acute medical or psychiatric conditions requiring immediate intervention.

2. Developmental or intellectual disabilities that significantly impair participation in the rehabilitation program or assessments.

3. Current substance dependence that would interfere with participation.

4. Significant risk of harm to self or others, based on clinical assessment or history of violence/aggression.

5. Contraindications to specific rehabilitation program components (e.g., physical exercise, group activities) as determined by medical evaluation.

6. Inability to comprehend study requirements or provide informed consent due to language barriers, cognitive impairment, or other factors.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Oman Ministry of Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sara Habib

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara A. Habib, Specialist

Role: PRINCIPAL_INVESTIGATOR

Al Massara Hospital,MOH Oman

Locations

Al Massara Hospital

Muscat, Muḩāfaz̧at Masqaţ, Oman

Countries

Oman

Other Identifiers

MoH/CSR/24/28654

Identifier Type: -

Identifier Source: org_study_id