Clinical trial NCT06886607: The Effects of Mindfulness and Web-Based Physical Activity Program in Patients With Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia Disorders
Keywords: Schizophrenia
Mindfulness and web-based physical activity program
mental well-being
sleep quality
coping with stress
cardiovascular risk
Lead sponsor: Selcuk University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2025-03-20
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was a randomized controlled trial with pre-test and post-test control groups.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mental Well-Being total mean score
timeFrame: From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks
measure: Sleep Quality total mean score
timeFrame: From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks
measure: Self-Confident Approach, Optimistic Approach, Helpless Approach, Submissive Approach, and Seeking of Social Support total mean score
timeFrame: From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks
Secondary outcomes:
measure: Cardiovascular Risk
timeFrame: From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University Faculty of Medicine Hospital
Study officials:
affiliation: Selcuk University
name: Neslihan Lok, Prof. Dr
role: PRINCIPAL_INVESTIGATOR
References: