Schizophenia DisorderNCT06715553
Interventional Programs' Impact on Patients' Quality of Life and Functioning
A study testing BALANCE Program (Body, Art, Learning, Activities, Nutrition, Creativity, and Education) in people with Schizophenia Disorder and Interventional Study, run by Psychiatric Hospital of the Cross at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophenia Disorder, Interventional Study
- What is being tested?
- BALANCE Program (Body, Art, Learning, Activities, Nutrition, Creativity, and Education)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteLebanon
- Study dates
- 9 Aug 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals diagnosed with chronic schizophrenia according to DSM-V criteria
- Aged 18-65.
- Physically capable of participating in physical
- Clinically stable
Who cannot join
- Active substance use
- Severe cognitive impairment
- Intellectual disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Interventional Programs on Quality of Life and Functioning Among Patients With Schizophrenia
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.
Read the 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.
- Conditions
- Schizophenia Disorder, Interventional Study
- Being tested
- BALANCE Program (Body, Art, Learning, Activities, Nutrition, Creativity, and Education)
- Keywords
- schizophrenia, quality of life, Interventional program, Functional abilities
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BALANCE Program (Body, Art, Learning, Activities, Nutrition, Creativity, and Education)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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'.
Measured: Three months
Secondary outcomes (2)
Global Assessment of Functioning (GAF)
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.
Measured: three months
Questionnaire du focntionnement sociale (QFS)
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.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start9 Aug 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Schizophenia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psychiatric Hospital of the Cross
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marouan Zoghbi, Hopital Psychiatrique De La Croix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715553
- Sponsor's protocol ID
- HPC 001-08-2024
- Status last verified
- Dec 2024
- First submitted
- 13 Nov 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The psychiatric patients is considered as a vulnerable population and at this time we respectfully request no to share personal data although anonymous.
Publications
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.
PubMed 30618878Effect of psycho-educational intervention on drug adherence and quality of life among patients with Schizophrenia in Jigawa State, Nigeria
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.
PubMed 28367717Kang 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.
PubMed 27584836
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Interventional Programs on Quality of Life and Functioning Among Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT06715553
- Acronym / sponsor ID
- HPC 001-08-2024
- Conditions
- Schizophenia Disorder, Interventional Study
- Keywords
- schizophrenia, quality of life, Interventional program, Functional abilities
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Psychiatric Hospital of the CrossUniversity, hospital or other
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Behavioral: BALANCE Program (Body, Art, Learning, Activities, Nutrition, Creativity, and Education)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 |
| Control Group | No intervention | –This group will follow the standard care provided by the hospital without any type of intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals diagnosed with chronic schizophrenia according to DSM-V criteria
- Aged 18-65.
- Physically capable of participating in physical
- Clinically stable
Key exclusion criteria (3 listed)
- Active substance use
- Severe cognitive impairment
- Intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BALANCE Program (Body, Art, Learning, Activities, Nutrition, Creativity, and Education)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 | Behavioural | Interventional group |
Primary outcome
WHO Quality of Life-BREF (WHOQOL-BREF)
Time frame: 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)
Time frame: 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'.
2 secondary outcomes
Global Assessment of Functioning (GAF)
Time frame: three months
Questionnaire du focntionnement sociale (QFS)
Time frame: three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Results publication: PubMed 30618878Deenik 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.
- Results publicationEffect of psycho-educational intervention on drug adherence and quality of life among patients with Schizophrenia in Jigawa State, Nigeria
- Results publication: PubMed 28367717Hjorth 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.
- Results publication: PubMed 27584836Kang 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.
- The link describe the study site where the protocol is being applied.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The psychiatric patients is considered as a vulnerable population and at this time we respectfully request no to share personal data although anonymous.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BALANCE Program (Body, Art, Learning, Activities, Nutrition, Creativity, and Education) in people with Schizophenia Disorder and Interventional Study, run by Psychiatric Hospital of the Cross at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHO Quality of Life-BREF (WHOQOL-BREF) (time frame: three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06715553, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.