Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-02 @ 9:23 AM
Study NCT ID:
NCT06875557
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2025-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mind Matters; Unveiling the Impact of Digital Mental Health Intervention (DMHI) on Psychological Distress Among Youth
Sponsor:
Fatima Jinnah Women University
Organization:
Study Overview
Official Title:
MIND MATTERS; UNVEILING THE IMPACT OF DIGITAL MENTAL HEALTH INTERVENTION (DMHI) ON PSYCHOLOGICAL DISTRESS AMONG YOUTH
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
Detailed Description:
The current study will be designed to assess the efficacy of digital mental health intervention for the management of psychological distress among youth in Pakistan. The study will also examine the mediating role of Type-D personality in the relationship between childhood trauma/ substance abuse and psychological distress. The study will be conducted in two phases. Phase 1 will be a cross-sectional survey and phase 2 will be a randomized controlled trial. A sample of 367 young adults (aged 15-24 years) would be recruited for the cross-sectional survey from different institutions of Rawalpindi and Islamabad. In the 2nd phase, selected young adults will be equally divided into interventional (25 participants) and control group (25 participants). Type-D personality, childhood trauma, substance abuse and psychological distress will be measured with DS-14, CTQ-28, DAST-10, DASS-21 respectively. Type-D personality, childhood trauma, substance abuse will be identified as significant predictors of psychological distress. In phase 2 (RCT), the intervention group will receive an 8-week Digital Mental Health Intervention (DMHI), whereas the control group will not receive any intervention. This research will contribute to the growing literature on the benefits of digital mental health apps, suggesting DMHIs as a viable non-pharmacological approach in alleviating psychological distress among youth. It would underscore the importance of integrating digital mental health apps in mental health interventions, especially in cultures and contexts like Pakistan, where such approaches are emerging. .
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: