Clinical trial NCT06154798: World Digital Detox Program for Enhancing Women's Health & Well-being
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Menopause Related Conditions
Psychological Stress
Keywords: World Digital Detox Day Program
Lead sponsor: Innowage Limited
Sponsor class: INDUSTRY
Collaborators: name: Zep Foundation
name: Aarogyam UK
First posted: 2023-12-04
Enrollment: 73
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Menopausal Health-Related Quality of Life
timeFrame: Baseline to 6-weeks post intervention
Secondary outcomes:
measure: Clinical Global Impression Scale (CGI)
timeFrame: Baseline to 6-weeks post intervention
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: Baseline to 6-weeks post intervention
Other outcomes:
Locations:
city: Mumbai
country: India
facility: World Digital Detox Day
state: Maharashtra
Study officials:
affiliation: World Digital Detox Day, Zep Foundation
name: Rekha Chaudhari, PhD
role: STUDY_DIRECTOR
affiliation: Aarogyam UK
name: Neha Sharma, PhD
role: STUDY_CHAIR
References: