NCT07276451

Effectiveness of the DMHI and OPS Platform in Improving Participant QOL: a Randomised Controlled Trial.

Effectiveness of the Digital Mental Health Intervention and Open Peer Support Platform in Improving Participant Quality of Life: a Randomised Controlled Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Universidade Nova de Lisboa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

RCT to evaluate the efficacy of a digital mental health intervention platform with open peer support in improving participant quality of life.

Detailed description

The objective of this study is to evaluate the role of the DHMI and OPS platform (further referred to as "the Platform") in improving participants' QOL. Participants will be recruited through community outreach, advertisements in healthcare facilities, and online platforms (See Appendix 2 for sample advertisements and Appendix 5 for list of centres for potential outreach). The RCT will be a parallel study where participants are randomly assigned to one of the groups using computer-generated random allocation. Prior to enrolment, participants will be assessed on eligibility and given initial assessment scales to evaluate their mental, physical states, the results of which will be reviewed by study supervisors and a local clinical specialist, who will perform risk assessment and when needed recommend exclusion and referral to specialized care facilities, based on participant scores. Upon enrolment, the participants will be randomly assigned to one of two groups: intervention group and control group. The intervention group will immediately be granted 30 days of access to the Platform and its resources. The control group will be granted access to the Platform following a second round of assessment on day 31. The intervention group will also be required to complete outgoing assessment on day 31.

Conditions

• Anxiety
• Depression and Quality of Life
• Quality of Life

Interventions

Type	Name	Description
OTHER	Participation in digital mental health intervention and open peer support platform	Participants in the experimental group will be immediately enrolled in the Platform and will have access to several interactive (daily mindfulness exercises; open dialogue group sessions; peer support forum; mentor chat) and passive (resource library: pre-recorded videos and guides) components for a total of 30 days, after which a final assessment will be performed on day 31. Control group participants will not be granted access to the Platform through the duration of the trial.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-05-01
• Completion: 2026-09-01
• First posted: 2025-12-11
• Last updated: 2025-12-11

Locations

1 site across 1 country: Portugal