World Digital Detox Program for Enhancing Women's Health & Well-being

Menopause Clinical Trial

Official title:

Effectiveness of World Digital Detox Program on Psychological Distress, Psychosocial Factors, Menopause Symptoms, and Physical Health Outcome in Women: Pragmatic Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06154798
• Other study ID #: Zep-WDDD-I 02
• Status: Completed
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: July 30, 2023

Study information

• Verified date: November 2023
• Source: Innowage Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The concept of a digital detox, involving a deliberate reduction or elimination of digital device usage, has emerged as a potential strategy to mitigate the adverse effects of technology on mental and physical well-being. However, the specific effects of a structured digital detox program on psychological distress, psychosocial factors, menopause symptoms, and overall physical health in a community context remain underexplored.

This study seeks to address this gap by conducting a real-world trial, examining the impact of a digital detox program tailored for women. By delving into the intricacies of how digital technology interacts with the unique challenges faced by women, this research aims to contribute valuable insights into the development of real-world-driven interventions that promote the holistic well-being of women in the digital age.

Description:

Excessive screen time and social media use during menopause pose multifaceted challenges. Prolonged exposure to screens can disrupt sleep patterns and exacerbate existing sleep disturbances, impacting the hormonal balance crucial for menopausal women. Social media's potential to induce stress, anxiety, and negative self-perception adds an emotional layer, while sedentary screen-related behavior may contribute to physical health concerns such as weight gain and decreased bone density, issues already pertinent to menopausal women. The impact on interpersonal relationships, cognitive function, body image, and time management further complicates the landscape, highlighting the need for mindful strategies to navigate the intersection of menopause and digital habits.

The World Digital Detox Program, developed by the Zep Foundation, takes a comprehensive approach to address challenges associated with increased screen and social media use, extending its focus to encompass the unique challenges faced by women during menopause. The concept of a digital detox, involving a deliberate reduction or elimination of digital device usage, has emerged as a potential strategy to mitigate the adverse effects of technology on mental and physical well-being.

The overarching aim is to enhance the comprehensive well-being of women in the digital era, going beyond addressing broad concerns of prolonged screen usage. The focus is on tailoring interventions to meet the distinct needs of women navigating the complexities of menopause. This involves incorporating practices such as breathwork, exercise, dietary adjustments, and overall well-being strategies, ensuring a holistic approach that considers the unique challenges and requirements of women during this life stage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: July 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• Menopausal staging: perimenopause or postmenopausal as per STRAW definitions

• Speak, read, and write in English sufficiently to comprehend materials in group treatment.

Exclusion Criteria:

• Participants who are severely depressed

• Need for acute treatment

• Participants with Psychotic Disorders, or current Substance Dependence.

• On Hormonal Replacement Therapy or intent to in next 3-months

Related Conditions & MeSH terms

• Menopause
• Menopause Related Conditions
• Psychological Stress
• Stress, Psychological

Intervention

Behavioral:
• World Digital Detox Women's Health Program
World Digital Detox Women's Health Program incorporates gradual steps, including mindfulness exercises, setting boundaries on digital usage, decluttering digital spaces, promoting offline connections, and encouraging mindful technology use.

Locations

Country	Name	City	State
India	World Digital Detox Day	Mumbai	Maharashtra

Sponsors (3)

Lead Sponsor	Collaborator
Innowage Limited	Aarogyam UK, Zep Foundation

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menopausal Health-Related Quality of Life	Menopausal Health-Related Quality of Life -38 items questionnaire score on a 4-point or binary scale covering 4 major domains (physical health, mental health, life satisfaction, and social involvement) of a woman's health during the menopausal transition	Baseline to 6-weeks post intervention
Secondary	Clinical Global Impression Scale (CGI)	The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).	Baseline to 6-weeks post intervention
Secondary	Client Satisfaction Questionnaire (CSQ)	CSQ-8 items scores on a 4-point scale (possible range from eight to 32, where a higher score indicates a higher level of overall satisfaction with services,	Baseline to 6-weeks post intervention