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

NCT06715553 | Active Not Recruiting DMC

• 1 other identifier: HPC 001-08-2024
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophenia Disorder; Interventional Study

Keywords

schizophrenia; quality of life; Interventional program; Functional abilities

Outcome Measures

Primary Outcomes (2)

• WHO Quality of Life-BREF (WHOQOL-BREF)

  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.

  three months

• The 5-level EQ-5D version (EQ-5D-5L)

  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'.

  Three months

Secondary Outcomes (2)

• Global Assessment of Functioning (GAF)

  three months

• Questionnaire du focntionnement sociale (QFS)

  three months

Other Outcomes (1)

• Clinical symptoms

  three months

Study Arms (2)

Interventional group

EXPERIMENTAL

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

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

Control Group

NO INTERVENTION

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

Interventions

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

Six types of intervention will be done on the patients as follows: * Psychoeducational intervention program * Art therapy program * Bibliotherapy program * Nutrition program * Sport activity * Ping Pong activity

Interventional group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Active substance use
• Severe cognitive impairment
• Intellectual disability

Sponsors & Collaborators

• Psychiatric Hospital of the Cross: lead

Study Sites (1)

Psychiatric Hospital of the Cross

Beirut, Lebanon

Location

Related Publications (4)

• 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.

  PMID: 30618878 BACKGROUND

• Effect of psycho-educational intervention on drug adherence and quality of life among patients with Schizophrenia in Jigawa State, Nigeria

  BACKGROUND

• 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.

  PMID: 28367717 BACKGROUND

• 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.

  PMID: 27584836 BACKGROUND

Related Links

• The link describe the study site where the protocol is being applied.

MeSH Terms

Conditions

Schizophrenia

Interventions

Reproductive Techniques, Assisted; Educational Status; Exercise; Nutritional Status

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Reproductive Techniques; Therapeutics; Investigative Techniques; Socioeconomic Factors; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Family medicine specialist

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: December 4, 2024
• Study Start: August 9, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 10, 2025

Record last verified: 2024-12

Locations

LE (1)