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The Effects of Mindfulness and Web-Based Physical Activity Program in Patients With Schizophrenia

The Effects of Mindfulness and Web-Based Physical Activity Program on Mental and Cardiovascular Risk in Patients With Schizophrenia: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06886607
Enrollment
50
Registered
2025-03-20
Start date
2023-10-16
Completion date
2024-01-31
Last updated
2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia Disorders

Keywords

Schizophrenia, Mindfulness and web-based physical activity program, mental well-being, sleep quality, coping with stress, cardiovascular risk

Brief 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. 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.

Interventions

BEHAVIORALthe Mindfulness and Web-Based Physical Activity Program

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.

Sponsors

The Scientific and Technological Research Council of Turkey
CollaboratorOTHER
Selcuk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This study was a randomized controlled trial with pre-test and post-test control groups.

Eligibility

Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Mental Well-Being total mean scoreFrom enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeksThe 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 scoreFrom enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeksPittsburgh 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 scoreFrom enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeksThe 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.

Secondary

MeasureTime frameDescription
Cardiovascular RiskFrom enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeksThis 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026