Clinical trial NCT06875557: Mind Matters; Unveiling the Impact of Digital Mental Health Intervention (DMHI) on Psychological Distress Among Youth
Official title: MIND MATTERS; UNVEILING THE IMPACT OF DIGITAL MENTAL HEALTH INTERVENTION (DMHI) ON PSYCHOLOGICAL DISTRESS AMONG YOUTH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Psychological Distress
Lead sponsor: Fatima Jinnah Women University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 376
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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. .

Eligibility criteria: Inclusion Criteria: Young boys and girls ranging from 15 to 24 years and those who agreed to participate in the study, not have been diagnosed with any chronic physical or mental illness were included as sample for the study, particularly all those respondents who were fluent in English language (as mode of language used in the questionnaires and the Digital Mental Health Intervention) and own an iPhone, iPad, iPod or smartphone with access to the internet.

- Exclusion Criteria: Participants excluded from the study were those who did not fulfil the inclusion criteria: Young boys and girls under the age of 15 years and above 24 years as well as those who didn't had access to smartphone, iPad, iPhone or any other such device; unavailability of internet service; those who were suffering from any severe psychiatric illness, either in the present or in the past; especially those who were on medication or treatment for such problem in the last one year; those suffering from any deliberating physical disease or disability, either in the present or in the past; those who were on any kind of long-term medication for any disease or disorder; as these all can negatively affect the results of the study.

-

Primary outcomes:
measure: Depression Anxiety Stress Scale (DASS-21)
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Fatima Jinnah Women University
state: Punjab
Study officials:
affiliation: Fatima Jinnah Women University
name: Madeeha Fatima Fatima, M.Phil Scholar
role: PRINCIPAL_INVESTIGATOR
References: