Interventional Programs' Impact on Patients' Quality of Life and Functioning

Psychiatric Hospital of the Cross

Status: Active, not recruiting

Conditions: Interventional Study; Schizophenia Disorder

Treatments: Behavioral: BALANCE Program (Body, Art, Learning, Activities, Nutrition, Creativity, and Education)

Study type: Interventional

Funder types: Other

Identifiers

NCT06715553

HPC 001-08-2024

Details and patient eligibility

About

The objective of the study is to investigate the effect of interventional program in improving the quality of life for individuals with chronic schizophrenia The design of the study will be an interventional study - Randomized Control Trial - taking place in the Psychiatric hospital of the Cross Lebanon. Six types of intervention will be done on the patients such as ping-pong, sport exercise, psychoeducation program, nutrition, art therapy and bibliotherapy. A 100 patients adhering to the inclusion and exclusion criteria will be randomized into two groups (50 patients in the intervention group and 50 patients in the control group) - Simple Randomization. A Baseline and follow-up assessments will take place at the beginning of the study and after three months through using Arabic Validated Scales. The scales that be used are the following Positive and negative symptoms scale (PANSS), to determine severity of symptoms in patients. WHO quality of life questionnaire WHOQOL- BREF Arabic version: physical, psychological, social and environmental and EQ-5D scale, to determine quality of life of patients. MOCA scale to determine cognitive function, Rosenberg self-esteem questionnaire, Social functioning questionnaire QFS and Birchwood Insight Scale.

Full description

Schizophrenia is considered to be one of the most disabling medical conditions in the world. It is characterized by a typical on-set in late adolescence to early adulthood, and a low remission rate, it is regarded as being a burden to patients' daily lives. Since there is evidence that the Quality of Life in patients with Schizophrenia is lower than the general population, it is believed that adhering to an interventional program might alleviate negative symptoms and cognitive deficits, leading to an improvement in Quality of Life.

Thus, this study will assess the impact of interventional program on improving the overall Quality of Life in patients with schizophrenia. Also, to assess the impact of the program on functional abilities, including occupational, social, and daily living skills, in patients with schizophrenia.

Participants will be recruited from the Psychiatric Hospital of the Cross. Eligible participants include individuals diagnosed with chronic schizophrenia, aged 18-65, and have given informed consent. To ensure the integrity and validity of the study, participants will be randomly assigned to either the intervention group or the control group (standard care) using randomized software.

By employing this randomization technique, we aim to minimize selection bias and ensure the comparability of the groups, thereby upholding the study's rigor and validity.

Intervention programs:

Six types of intervention will be done on the patients as follows:

• Psychoeducational intervention program prepared and will be applied by a psychologist
• Art therapy program will be done by a psychologist
• Bibliotherapy program will be done by a neuroscience person
• Nutrition program will be done a nutritionist
• Sport activity will be held by a physical trainee
• Ping Pong activity will be done by a ping pong trainer Data will be collected through direct observations, participant self-reports, and standardized assessments conducted by trained research staff.

Enrollment: 86 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals diagnosed with chronic schizophrenia according to DSM-V criteria
• Aged 18-65.
• Physically capable of participating in physical
• Clinically stable

Exclusion criteria

• Active substance use
• Severe cognitive impairment
• Intellectual disability

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups

Interventional group

Experimental group

Description:

Participants will be randomly assigned to the intervention group Six types of intervention will be done on the patients as follows: * Psychoeducational intervention program prepared and will be applied by a psychologist * Art therapy program will be done by a psychologist * Bibliotherapy program will be done by a neuroscience person * Nutrition program will be done a nutritionist * Sport activity will be held by a physical trainee * Ping Pong activity will be done by a ping pong trainer

Treatment:

Behavioral: BALANCE Program (Body, Art, Learning, Activities, Nutrition, Creativity, and Education)

Control Group

No Intervention group

Description:

This group will follow the standard care provided by the hospital without any type of intervention