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

NCT ID: NCT06875557

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

376 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-12

Study Completion Date

2024-09-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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. .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psychological Distress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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.

Group Type EXPERIMENTAL

Digital Mental Health Intervention (DMHI)

Intervention Type 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.

Waitlist Control : who would receive intervention after the study completion

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.

Group Type ACTIVE_COMPARATOR

Digital Mental Health Intervention (DMHI)

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Digital Mental Health Intervention (DMHI)

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.

Intervention Type BEHAVIORAL

Digital Mental Health Intervention (DMHI)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-
Minimum Eligible Age

15 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fatima Jinnah Women University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Madeeha Fatima

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Madeeha Fatima Fatima, M.Phil Scholar

Role: PRINCIPAL_INVESTIGATOR

Fatima Jinnah Women University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fatima Jinnah Women University

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Related Links

Access external resources that provide additional context or updates about the study.

https://doi.org/10.1097/01.psy.0000149256.81953.49

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FJWU/EC/2024/92

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Teenage Health and Wellness Study
NCT03989934 COMPLETED NA