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

Not Applicable

Active, not recruiting

• Conditions: Schizophenia Disorder; Interventional Study

• Registration Number: NCT06715553
• Lead Sponsor: Psychiatric Hospital of the Cross

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.

Study Timeline

• Study Start: 2024-08-09
• Study First Submitted: 2024-11-13
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-04
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
WHO Quality of Life-BREF (WHOQOL-BREF)	three months	The WHOQOL-BREF measure the subjects' perception of QOL in every domain and the subjects' satisfaction with health and overall rating of QOL.; The WHOQOL-BREF is a shortened version of the WHOQOL-100, it is composed of 26 items that uses a 5 point response scale ranging from 1 (very dissatisfied/very poor) to 5 (very satisfied/very good). Four domains were addressed including the physical health (seven items, Q3, Q4, Q10, Q15, Q16, Q17, Q18), psychological health (six items, Q5, Q6, Q7, Q11, Q19, Q26), social relations (three items, Q20, Q21, Q22), and environment (eight items, Q8, Q9, Q12, Q13, Q14, Q23, Q24, Q25).; Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life) with elevated score indicating higher quality of life. The mean score of items within each domain is used to calculate the domain score. Mean scores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100.
The 5-level EQ-5D version (EQ-5D-5L)	Three months	The 5-level EQ-5D version (EQ-5D-5L) questionnaire is a globally used and multiply validated tool to assess health-related quality of life (HRQoL). It consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).; The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

Secondary Outcome Measures

Name	Time	Method
Global Assessment of Functioning (GAF)	three months	Global Assessment of Functioning (GAF) is a scoring system used to assess the severity of illness in psychiatry. It measures how much a person's symptoms affect their day-to-day life on a scale of 0 to 100. It is a numeric scale (0 through 100) used by mental health professionals and physicians to subjectively rate the social, occupational, and psychological functioning of adults. The highest ratings are 91-100, "Superior functioning in a wide range of activities and the lowest ratings (besides a 0, for "Inadequate information") are 1-10, "Persistent danger of severely hurting self or others...OR persistent inability to maintain minimal personal hygiene OR serious suicidal act with clear expectation of death.
Questionnaire du focntionnement sociale (QFS)	three months	Questionnaire du focntionnement sociale (QFS) It is a brief self-assessment questionnaire made up of 16 questions covering the general functioning in the last 15 days. Eight questions assess the frequency of social behaviors, and the eight other questions focus on satisfaction that is withdrawn from these behaviors. The QFS makes it possible to calculate three main indices: a "Frequency" index, a "Satisfaction" index and a "Global" index, which corresponds to the sum of the two previous ones. The "Frequency" and "Satisfaction" index scores range from 8 to 40 while the "Overall" index score ranges from 16 to 80. A higher score corresponds to a better level of functioning.

Trial Locations

Locations (1)

Psychiatric Hospital of the Cross; 🇱🇧 Beirut, Lebanon