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Completed

NCT Number: NCT06154798

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

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.

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Key information

Conditions

Menopause Behavior Behavioral Symptoms Menopause Related Conditions Psychological Stress Stress, Psychological

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

World Digital Detox Day

Mumbai, Maharashtra, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

World Digital Detox Women's Health Program

Behavioral

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.

Primary outcomes

  1. Menopausal Health-Related Quality of Life

    Time frame: Baseline to 6-weeks post intervention

    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

Secondary outcomes

  1. Clinical Global Impression Scale (CGI)

    Time frame: Baseline to 6-weeks post intervention

    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).

  2. Client Satisfaction Questionnaire (CSQ)

    Time frame: Baseline to 6-weeks post intervention

    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,

Sponsors and collaborators

Lead sponsor

Innowage Limited

Industry

Collaborators

  • Aarogyam UK
  • Zep Foundation

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 4, 2023
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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