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

NCT06886607 | Completed

• 1 other identifier: SelcukU-GUzun-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia Disorders

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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".

  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.

  From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks

Secondary Outcomes (1)

• Cardiovascular Risk

  From enrollment to the end of the Mindfulness and Web-Based Physical Activity Program at 14 weeks

Study Arms (2)

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.

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.

Interventions

the Mindfulness and Web-Based Physical Activity Program 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.

Intervention

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Selcuk University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Selcuk University Faculty of Medicine Hospital

Konya, 42230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Schizophrenia; Psychological Well-Being; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Personal Satisfaction; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Neslihan Lok, Prof. Dr

  Selcuk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

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

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 20, 2025
• Study Start: October 16, 2023
• Primary Completion: January 16, 2024
• Study Completion: January 31, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)