Mind Matters; Unveiling the Impact of Digital Mental Health Intervention (DMHI) on Psychological Distress Among Youth

NCT06875557 | Completed Phase 1 DMC

• 1 other identifier: FJWU/EC/2024/92
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

Brief Summary

The current study would be designed to identify the impact of digital mental health intervention on psychological distress among youth through Insight Timer app focusing on reiki healing techniques. Furthermore, in this study, the predictors such as Childhood Trauma, Type-D personality and Substance Abuse would be studied that will be associated with psychological distress among youth. Moreover, the study will also focus on the mediating role of Type-D personality in the relationship between childhood trauma and psychological distress, and substance abuse and psychological distress, as indicated by existing theories and literature (Luo et al., 2022; Javakhishvili \& Widom, 2021). The study will further investigate the effectiveness of Digital Mental Health Intervention (DMHI) for type-D personality and childhood trauma (emotional abuse, physical abuse, sexual abuse, emotional neglect, physical neglect).

Conditions

Psychological Distress

Outcome Measures

Primary Outcomes (1)

• Depression Anxiety Stress Scale (DASS-21)

  Depression Anxiety and Scale Scale (DASS-21, Lovibond \& Lovibond, 1995; was used to assess psychological distress in terms of depression, anxiety and stress in the participants. It contains 21 items with three 7-items subscales; depression (item number 3, 5, 10, 13, 16, 17 and 21), anxiety (item number 2, 4, 7, 9, 15, 19 and 20) and stress (1, 6, 8, 11, 12, 14 and 18). Participants responded on a Likert scale which ranged from 0 i.e., "did not apply to me at all" to selecting 3 i.e., "applied to me very much, or most of the time". It assessed the degree to which symptoms had been present in the past week.

  2 months

Study Arms (2)

Interventional : who receives intervention i.e., Digital Mental Health Intervention (DMHI)

EXPERIMENTAL

Digital Mental Health Intervention (DMHI) was provided to the sample of young adults who were experiencing psychological distress. DMHI was being given through Insight Timer application that only focused on reiki healing techniques. Insight Timer is a mobile app that provides guided meditations to calm the mind, alleviate anxiety, manage stress, achieve deep sleep, and enhance well-being and happiness. Additionally, it offers calm and soothing music, educational courses, live events, and workshops in multiple languages. (Insight Network, Inc., n.d.). The app is FREE to download with an email allowing access to their collection of meditation recordings. Insight Timer's free-to-use feature is most suitable for community groups.

Behavioral: Digital Mental Health Intervention (DMHI)

Waitlist Control : who would receive intervention after the study completion

ACTIVE COMPARATOR

Digital Mental Health Intervention (DMHI) was provided to the sample of young adults who were experiencing psychological distress. DMHI was being given through Insight Timer application that only focused on reiki healing techniques. Insight Timer is a mobile app that provides guided meditations to calm the mind, alleviate anxiety, manage stress, achieve deep sleep, and enhance well-being and happiness. Additionally, it offers calm and soothing music, educational courses, live events, and workshops in multiple languages. (Insight Network, Inc., n.d.). The app is FREE to download with an email allowing access to their collection of meditation recordings. Insight Timer's free-to-use feature is most suitable for community groups.

Behavioral: Digital Mental Health Intervention (DMHI)

Interventions

Digital Mental Health Intervention (DMHI) BEHAVIORAL

In the current study, the impact of Digital Mental Health Intervention (DMHI) would be examined through Insight Timer application, focusing on just its one aspect (Reiki healing techniques). Through the usage of DMHIs in the young population, youth would be better able to express their psychological issues with the healthcare professionals instead of the fear of being labelled or stigmatization.

Interventional : who receives intervention i.e., Digital Mental Health Intervention (DMHI)

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Fatima Jinnah Women University: lead

Study Sites (1)

Fatima Jinnah Women University

Rawalpindi, Punjab Province, Pakistan

Location

Related Links

• Denollet, J. (2005). DS14: Standard assessment of negative affectivity, social inhibition, and Type D personality. Psychosomatic Medicine, 67(1), 89-97. https://doi.org/10.1097/01.psy.0000149256.81953.49

Study Officials

• Madeeha Fatima Fatima, M.Phil Scholar

  Fatima Jinnah Women University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: March 13, 2025
• Study Start: August 12, 2024
• Primary Completion: September 28, 2024
• Study Completion: September 28, 2024
• Last Updated: March 13, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)