Schizophrenia DisordersNCT06886607
The Effects of Mindfulness and Web-Based Physical Activity Program in Patients With Schizophrenia
A study testing the Mindfulness and Web-Based Physical Activity Program in people with Schizophrenia Disorders, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This study was aimed to examine the effects of the Mindfulness and Web-Based Physical Activity Program - consisting of two weeks of mindfulness skills followed by 12 weeks of walking and exercise - delivered through videos uploaded to a YouTube channel on mental and cardiovascular risk in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Schizophrenia Disorders
- What is being tested?
- the Mindfulness and Web-Based Physical Activity Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Oct 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being registered at the Mental Health and Illnesses Outpatient Clinic of S.U. Faculty of Medicine Hospital,
- Having been diagnosed with schizophrenia for at least 1 year
- Being between the ages of 25 and 55,
- Having scored mild to moderate on the Positive and Negative Syndrome Scale (PANSS)
- Having access to technological devices such as smartphones, computers, and tablets to watch videos from a YouTube channel.
Who cannot join
- Having physical, mental, visual, or hearing disabilities,
- Being involved in a program similar to the intervention to be applied,
- Having a condition that would prevent them from exercising,
- Having a diagnosis of heart disease or stroke.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University Faculty of Medicine Hospital
Konya, 42230
About this study
Official title: The Effects of Mindfulness and Web-Based Physical Activity Program on Mental and Cardiovascular Risk in Patients With Schizophrenia: A Randomized Controlled Trial
This study was aimed to examine the effects of the Mindfulness and Web-Based Physical Activity Program - consisting of two weeks of mindfulness skills followed by 12 weeks of walking and exercise - delivered through videos uploaded to a YouTube channel on mental and cardiovascular risk in patients with schizophrenia. The main questions it aims to answer are:
After the Mindfulness and Web-Based Physical Activity Program, H1-1: There is a statistically significant difference in the mean total scores of mental well-being between the intervention and control groups.
Read more
H1-2: There is a statistically significant difference in the mean total scores of sleep quality between the intervention and control groups.
H1-3: There is a statistically significant difference in the mean total scores of the subscales of the Coping Style Scale (self-confident approach, optimistic approach, helpless approach, submissive approach, and seeking of social support) between the intervention and control groups.
H1-4: There is a statistically significant difference in terms of cardiovascular risk levels between the intervention and control groups.
Researchers were compared the Mindfulness and Web-Based Physical Activity Program to a control group (no intervention) to see if the Mindfulness and Web-Based Physical Activity Program works on mental and cardiovascular risk in patients with schizophrenia.
Participants were:
- followed in the first phase of the Mindfulness and Web-Based Physical Activity Program, the "Mindfulness Skill Development Program", which included activities for individuals to develop their mindfulness skills, five days a week for two weeks from October 23 to November 3, 2023 through videos uploaded on the YouTube channel.
- followed in the second phase of the Mindfulness and Web-Based Physical Activity Program, the 12-week "Mindful Physical Activity Program", which consisted of "Mindful Walking" and "Mindful Physical Activity Day" sessions held twice a week (Tuesday and Thursday) and three days a week for 50 minutes from November 2023 to January 2024 through videos uploaded on the YouTube channel.
Read the detailed description
The study included 110 individuals aged 25-55 who were diagnosed with schizophrenia and applied to the S.U. Faculty of Medicine Mental Health and Diseases Polyclinic in the last year, and were examined according to the inclusion-exclusion criteria. A total of 50 individuals were included in the study. These individuals were randomly assigned to two groups: intervention and control. Pre-test data were collected using the "Personal Information Form", "Mental Well-Being Scale", "Pittsburgh Sleep Quality Index (PSQI)", "Coping Style Scale", and "QRISK3 Index" from the intervention and control groups by researchers between October 2023 and January 2024 in the Group Therapy Room of the Mental Health and Diseases Polyclinic, based on self-reporting. The "Mindfulness and Web-Based Physical Activity Program" was completed in a total of 14 weeks, consisting of a 2-week "Mindfulness Skill Development Program" and a 12-week "Mindful Physical Activity Program" to intervention group through videos uploaded on the YouTube channel opened via the web. Before starting the Mindful Physical Activity Program, all participants in the intervention group were provided with sports shoes, resistance bands, exercise mats, and pedometers to encourage regular participation in physical activity. Additionally, the researchers gave participants the Mindful Physical Activity Program Follow-up Form and the Mindful Walking Follow-up Form to track their daily involvement in the program. At the end of the Mindfulness and Web-Based Physical Activity Program, both the intervention and control groups were administered the "Mental Well-Being Scale", "Pittsburgh Sleep Quality Index-PSQI", "Coping Style Scale", and "QRISK3 Index". No intervention was applied to the control group throughout the 14-week program; the patients continued with their daily routine activities.
- Conditions
- Schizophrenia Disorders
- Being tested
- the Mindfulness and Web-Based Physical Activity Program
- Keywords
- Schizophrenia, Mindfulness and web-based physical activity program, mental well-being, sleep quality, coping with stress, cardiovascular risk
- Medical subject headings
- Schizophrenia, Psychological Well-Being, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the Mindfulness and Web-Based Physical Activity ProgramBehavioural
The "Mindfulness and Web-Based Physical Activity Program" consists of two phases: the "Mindfulness Skill Development Program" and the "Mindful Physical Activity Program". In the first phase of the Program, the "Mindfulness Skill Development Program" was implemented for two weeks, five days a week, from October 23 to November 3, 2023. The program includes activities for individuals to develop mindfulness skills through videos uploaded on the YouTube channel. In the second phase of the Program, The 12-week Mindful Physical Activity Program, implemented between November 2023 and January 2024, consisted of "Mindful Walking" and "Mindful Physical Activity Day" sessions held twice a week (Tuesday and Thursday) and three days a week for 50 minutes. Each session began with a 10-minute warm-up exercise, followed by 40 minutes of endurance and strength training sessions, and ended with 10 minutes of cool-down exercises.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group was a group of 25 people consisting of patients with schizophrenia who followed the 14-week Mindfulness and Web-Based Physical Activity Program. Receives: Behavioral: the Mindfulness and Web-Based Physical Activity Program |
| Control | No intervention | No intervention was applied to the control group throughout the 14-week program; the patients continued with their daily routine activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Well-Being total mean score
The Mental Well-Being Scale scores range from 14 to 70 points. A higher score on the scale indicates a higher level of mental well-being.
Measured: From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks
Sleep Quality total mean score
Pittsburgh sleep quality index (PSQI) scores range from 0 to 21 points. A total score greater than 5 indicates "poor sleep quality".
Measured: From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks
Self-Confident Approach, Optimistic Approach, Helpless Approach, Submissive Approach, and Seeking of Social Support total mean score
The 30-item Coping style scale (CSS) consists of a total of five subscales: Self-Confident Approach, Optimistic Approach, Helpless Approach, Submissive Approach, and Seeking of Social Support. The scale is evaluated based on its subdimensions. The scale has no total score. The total scores to be obtained from the sub-dimensions are as follows: 21 for self-confident approach, 15 for optimistic approach, 24 for helpless approach, 18 for submissive approach, and for 12 for seeking of social support. In the evaluation of the scale, the increase in scores obtained from the factors of self-confident, optimistic, and seeking of social support indicates that coping with stress is effective; whereas the increase in scores obtained from the factors of helpless approach and submissive approach shows that ineffective methods are being used to cope with stress. A high score on the sub-dimensions indicates that the individual uses the respective approach more frequently.
Measured: From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks
Secondary outcomes (1)
Cardiovascular Risk
This algorithm is used to calculate the 10-year cardiovascular disease risk of patients. As recommended in the QRISK*3 algorithm (https://www.qrisk.org/). If the QRISK3 score is > 20, it is classified as high risk; between 10-20%, it is classified as moderate risk; and <10 is classified as low risk.
Measured: From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start16 Oct 2023
- Primary completion16 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was a randomized controlled trial with pre-test and post-test control groups.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Neslihan Lok, Selcuk University
- Investigators
- Neslihan Lok, Prof. Dr, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886607
- Sponsor's protocol ID
- SelcukU-GUzun-001
- Status last verified
- Mar 2025
- First submitted
- 9 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mindfulness and Web-Based Physical Activity Program on Mental and Cardiovascular Risk in Patients With Schizophrenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06886607
- Acronym / sponsor ID
- SelcukU-GUzun-001
- Conditions
- Schizophrenia Disorders
- Keywords
- Schizophrenia, Mindfulness and web-based physical activity program, mental well-being, sleep quality, coping with stress, cardiovascular risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 20 Mar 2025 (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.
This study was aimed to examine the effects of the Mindfulness and Web-Based Physical Activity Program - consisting of two weeks of mindfulness skills followed by 12 weeks of walking and exercise - delivered through videos uploaded to a YouTube channel on mental and cardiovascular risk in patients with schizophrenia. The main questions it aims to answer are:
After the Mindfulness and Web-Based Physical Activity Program, H1-1: There is a statistically significant difference in the mean total scores of mental well-being between the intervention and control groups.
H1-2: There is a statistically significant difference in the mean total scores of sleep quality between the intervention and control groups.
H1-3: There is a statistically significant difference in the mean total scores of the subscales of the Coping Style Scale (self-confident approach, optimistic approach, helpless approach, submissive approach, and seeking of social support) between the intervention and control groups.
H1-4: There is a statistically significant difference in terms of cardiovascular risk levels between the intervention and control groups.
Researchers were compared the Mindfulness and Web-Based Physical Activity Program to a control group (no intervention) to see if the Mindfulness and Web-Based Physical Activity Program works on mental and cardiovascular risk in patients with schizophrenia.
Participants were:
- followed in the first phase of the Mindfulness and Web-Based Physical Activity Program, the "Mindfulness Skill Development Program", which included activities for individuals to develop their mindfulness skills, five days a week for two weeks from October 23 to November 3, 2023 through videos uploaded on the YouTube channel.
- followed in the second phase of the Mindfulness and Web-Based Physical Activity Program, the 12-week "Mindful Physical Activity Program", which consisted of "Mindful Walking" and "Mindful Physical Activity Day" sessions held twice a week (Tuesday and Thursday) and three days a week for 50 minutes from November 2023 to January 2024 through videos uploaded on the YouTube channel.
Detailed description
The study included 110 individuals aged 25-55 who were diagnosed with schizophrenia and applied to the S.U. Faculty of Medicine Mental Health and Diseases Polyclinic in the last year, and were examined according to the inclusion-exclusion criteria. A total of 50 individuals were included in the study. These individuals were randomly assigned to two groups: intervention and control. Pre-test data were collected using the "Personal Information Form", "Mental Well-Being Scale", "Pittsburgh Sleep Quality Index (PSQI)", "Coping Style Scale", and "QRISK3 Index" from the intervention and control groups by researchers between October 2023 and January 2024 in the Group Therapy Room of the Mental Health and Diseases Polyclinic, based on self-reporting. The "Mindfulness and Web-Based Physical Activity Program" was completed in a total of 14 weeks, consisting of a 2-week "Mindfulness Skill Development Program" and a 12-week "Mindful Physical Activity Program" to intervention group through videos uploaded on the YouTube channel opened via the web. Before starting the Mindful Physical Activity Program, all participants in the intervention group were provided with sports shoes, resistance bands, exercise mats, and pedometers to encourage regular participation in physical activity. Additionally, the researchers gave participants the Mindful Physical Activity Program Follow-up Form and the Mindful Walking Follow-up Form to track their daily involvement in the program. At the end of the Mindfulness and Web-Based Physical Activity Program, both the intervention and control groups were administered the "Mental Well-Being Scale", "Pittsburgh Sleep Quality Index-PSQI", "Coping Style Scale", and "QRISK3 Index". No intervention was applied to the control group throughout the 14-week program; the patients continued with their daily routine activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was a randomized controlled trial with pre-test and post-test control groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: the Mindfulness and Web-Based Physical Activity ProgramThe intervention group was a group of 25 people consisting of patients with schizophrenia who followed the 14-week Mindfulness and Web-Based Physical Activity Program. |
| Control | No intervention | –No intervention was applied to the control group throughout the 14-week program; the patients continued with their daily routine activities. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being registered at the Mental Health and Illnesses Outpatient Clinic of S.U. Faculty of Medicine Hospital,
- Having been diagnosed with schizophrenia for at least 1 year
- Being between the ages of 25 and 55,
- Having scored mild to moderate on the Positive and Negative Syndrome Scale (PANSS)
- Having access to technological devices such as smartphones, computers, and tablets to watch videos from a YouTube channel.
Key exclusion criteria (4 listed)
- Having physical, mental, visual, or hearing disabilities,
- Being involved in a program similar to the intervention to be applied,
- Having a condition that would prevent them from exercising,
- Having a diagnosis of heart disease or stroke.
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 |
|---|---|---|
| the Mindfulness and Web-Based Physical Activity ProgramThe "Mindfulness and Web-Based Physical Activity Program" consists of two phases: the "Mindfulness Skill Development Program" and the "Mindful Physical Activity Program". In the first phase of the Program, the "Mindfulness Skill Development Program" was implemented for two weeks, five days a week, from October 23 to November 3, 2023. The program includes activities for individuals to develop mindfulness skills through videos uploaded on the YouTube channel. In the second phase of the Program, The 12-week Mindful Physical Activity Program, implemented between November 2023 and January 2024, consisted of "Mindful Walking" and "Mindful Physical Activity Day" sessions held twice a week (Tuesday and Thursday) and three days a week for 50 minutes. Each session began with a 10-minute warm-up exercise, followed by 40 minutes of endurance and strength training sessions, and ended with 10 minutes of cool-down exercises. | Behavioural | Intervention |
Primary outcome
Mental Well-Being total mean score
Time frame: From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks
The Mental Well-Being Scale scores range from 14 to 70 points. A higher score on the scale indicates a higher level of mental well-being.
Sleep Quality total mean score
Time frame: From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks
Pittsburgh sleep quality index (PSQI) scores range from 0 to 21 points. A total score greater than 5 indicates "poor sleep quality".
Self-Confident Approach, Optimistic Approach, Helpless Approach, Submissive Approach, and Seeking of Social Support total mean score
Time frame: From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks
The 30-item Coping style scale (CSS) consists of a total of five subscales: Self-Confident Approach, Optimistic Approach, Helpless Approach, Submissive Approach, and Seeking of Social Support. The scale is evaluated based on its subdimensions. The scale has no total score. The total scores to be obtained from the sub-dimensions are as follows: 21 for self-confident approach, 15 for optimistic approach, 24 for helpless approach, 18 for submissive approach, and for 12 for seeking of social support. In the evaluation of the scale, the increase in scores obtained from the factors of self-confident, optimistic, and seeking of social support indicates that coping with stress is effective; whereas the increase in scores obtained from the factors of helpless approach and submissive approach shows that ineffective methods are being used to cope with stress. A high score on the sub-dimensions indicates that the individual uses the respective approach more frequently.
1 secondary outcome
Cardiovascular Risk
Time frame: From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Neslihan Lok, Prof. Dr principal investigator
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the Mindfulness and Web-Based Physical Activity Program in people with Schizophrenia Disorders, run by Selcuk University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 20 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mental Well-Being total mean score (time frame: From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2025.