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

NCT06154798 | Completed DMC

• 1 other identifier: Zep-WDDD-I 02
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Menopause Related Conditions; Psychological Stress

Keywords

World Digital Detox Day Program

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinical Global Impression Scale (CGI)

  Baseline to 6-weeks post intervention

• Client Satisfaction Questionnaire (CSQ)

  Baseline to 6-weeks post intervention

Study Arms (2)

World Digital Detox Women's Health Program

ACTIVE COMPARATOR

The intervention is a 6-week World Digital Detox Program designed to help participants reduce their dependence on digital devices and foster a healthier balance between technology use and overall well-being.

Behavioral: World Digital Detox Women's Health Program

Control Group

NO INTERVENTION

Participants assigned to the control group will continue with their regular, unrestricted digital device usage throughout the 6-week study period.

Interventions

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.

World Digital Detox Women's Health Program

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Women in Menopause stage
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Menopausal staging: perimenopause or postmenopausal as per STRAW definitions
• Speak, read, and write in English sufficiently to comprehend materials in group treatment.

You may not qualify if:

• 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

Sponsors & Collaborators

• Innowage Limited: lead
• Zep Foundation: collaborator
• Aarogyam UK: collaborator

Study Sites (1)

World Digital Detox Day

Mumbai, Maharashtra, India

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Rekha Chaudhari, PhD

  World Digital Detox Day, Zep Foundation

  STUDY DIRECTOR

• Neha Sharma, PhD

  Aarogyam UK

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 4, 2023
• Study Start: January 16, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

IN (1)