Clinical trial NCT06715553: Interventional Programs' Impact on Patients' Quality of Life and Functioning
Official title: The Effect of Interventional Programs on Quality of Life and Functioning Among Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Schizophenia Disorder
Interventional Study
Keywords: schizophrenia
quality of life
Interventional program
Functional abilities
Lead sponsor: Psychiatric Hospital of the Cross
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 86 patients adhering to the inclusion and exclusion criteria will be randomized into two groups (43 patients in the intervention group and 43 patients in the control group) and the interventional model type will be in Parallel.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: WHO Quality of Life-BREF (WHOQOL-BREF)
timeFrame: three months
measure: The 5-level EQ-5D version (EQ-5D-5L)
timeFrame: Three months
Secondary outcomes:
measure: Global Assessment of Functioning (GAF)
timeFrame: three months
measure: Questionnaire du focntionnement sociale (QFS)
timeFrame: three months
Other outcomes:
measure: Clinical symptoms
timeFrame: three months
Locations:
city: Beirut
country: Lebanon
facility: Psychiatric Hospital of the Cross
Study officials:
References:
citation: Deenik J, Tenback DE, van Driel HF, Tak ECPM, Hendriksen IJM, van Harten PN. Less Medication Use in Inpatients With Severe Mental Illness Receiving a Multidisciplinary Lifestyle Enhancing Treatment. The MULTI Study III. Front Psychiatry. 2018 Dec 18;9:707. doi: 10.3389/fpsyt.2018.00707. eCollection 2018.
citation: Effect of psycho-educational intervention on drug adherence and quality of life among patients with Schizophrenia in Jigawa State, Nigeria
citation: Hjorth P, Medici CR, Juel A, Madsen NJ, Vandborg K, Munk-Jorgensen P. Improving quality of life and physical health in patients with schizophrenia: A 30-month program carried out in a real-life setting. Int J Soc Psychiatry. 2017 Jun;63(4):287-296. doi: 10.1177/0020764017702172. Epub 2017 Apr 3.
citation: Kang R, Wu Y, Li Z, Jiang J, Gao Q, Yu Y, Gao K, Yan Y, He Y. Effect of Community-Based Social Skills Training and Tai-Chi Exercise on Outcomes in Patients with Chronic Schizophrenia: A Randomized, One-Year Study. Psychopathology. 2016;49(5):345-355. doi: 10.1159/000448195. Epub 2016 Sep 2.