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

NCT ID: NCT06886607

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2024-01-31

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.

Conditions

Schizophrenia Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

the Mindfulness and Web-Based Physical Activity Program

Intervention Type: BEHAVIORAL

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.

Control

No intervention was applied to the control group throughout the 14-week program; the patients continued with their daily routine activities.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

the 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Selcuk University

OTHER

Sponsor Role: lead

Responsible Party

Neslihan Lok

Prof.Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neslihan Lok, Prof. Dr

Role: PRINCIPAL_INVESTIGATOR

Selcuk University

Locations

Selcuk University Faculty of Medicine Hospital

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SelcukU-GUzun-001

Identifier Type: -

Identifier Source: org_study_id