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

NCT ID: NCT07276451

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1 (Intervention group)

Intervention group. Participants in the intervention group will be analysed according to their QOL scores and feedback on secondary conditions will be used for pooling and subgroup analyses. Participant in the intervention group will be determined through a randomised selection.

Group Type: EXPERIMENTAL

Participation in digital mental health intervention and open peer support platform

Intervention Type: OTHER

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.

Group 2 (control group)

Participants in the control group, included as a result of randomised selection, will be put on the waitlist to access the Platform throughout the duration of the trial. The control group participants will be granted access to the Platform on day 31 of the trial. The introductory and closing evaluations will be performed on both groups at similar time points. This group is the waitlist group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged ≥18 years;
• No current clinical diagnosis of a mental health disorder;
• No mental-health treatment or psychotropic medication initiated within the past 3 months;
• Able to access the internet and provide informed consent.

Exclusion Criteria

• Current engagement with a mental health professional or therapy;
• Inability to access the DMHI and OPS platform, or inability to provide informed consent;
• PHQ-9 score ≥15 or GAD-7 score ≥15 at baseline (these participants will be referred to specialist services and excluded from further study participation)

Confirmation of eligibility to participate. To comply with local regulations and ensure participant safety, a qualified and appropriately licensed specialist, affiliated with the institution will participate in screening of the participants recruitment results and carrying out decisions on whether to include or exclude the participant from the study based on degree of severity in the underlying psychological or psychiatric condition. The decision to exclude participants will be made based on safety considerations, need for emergency psychiatric help, compliance assumption and perceived efficacy.

Withdrawal. Participation is voluntary. All enrolled participants are free to withdraw from the study at any time with or without notice to study personnel.

Risk to self and/or others. During enrollment and study course, participants will be screened for severity of symptoms. If our participating specialist identifies a risk to self or others, appropriate actions will be taken to contact the authorities and local law representatives according to European and Local Law.

Sample size estimates. For two groups and a dichotomous endpoint (improvement or no improvement) and an anticipated incidence of 45% in the intervention group and 75% in the control group, at a 95% confidence level and 5% margin of error, power of 80% and enrolment ratio of 1, a sample size of 82 participants was chosen for this RCT (41 in intervention group, 41 in control group).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Nova de Lisboa

OTHER

Sponsor Role: lead

Responsible Party

Dmitry Shamenkov

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nova University of Lisbon

Lisbon, , Portugal

Countries

Portugal

Central Contacts

Dmitry Shamenkov

Role: CONTACT

ds.shamenkov@ensp.unl.pt

+351 910 825 243

Other Identifiers

21/2025

Identifier Type: -

Identifier Source: org_study_id