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

NCT07276451 | Not Yet Recruiting

• 1 other identifier: 21/2025
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety; Depression and Quality of Life; Quality of Life

Keywords

digital mental health intervention; open peer support; mental health; online support

Outcome Measures

Primary Outcomes (1)

• Primary outcome (WHOQOL-BREF change 0-31)

  Change in Overall Quality of Life, as measured by the WHOQOL-BREF total score, from baseline (day 0) to post-intervention (day 31), treated as a continuous variable. A clinically meaningful improvement is defined a priori as a ≥10% increase from baseline.

  1 month

Secondary Outcomes (6)

• SWLS

  1 month

• PSS

  1 month

• GAD-7

  1 month

• PHQ-9

  1 month

• Social Connectedness

  1 month

Other Outcomes (2)

• Mediator: adherence to platform

  1 month

• Mediator: concomitant medication use

  1 month

Study Arms (2)

Group 1 (Intervention group)

EXPERIMENTAL

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.

Other: Participation in digital mental health intervention and open peer support platform

Group 2 (control group)

NO INTERVENTION

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.

Interventions

Participation in digital mental health intervention and open peer support platform 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 1 (Intervention group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead

Study Sites (1)

Nova University of Lisbon

Lisbon, Portugal

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Central Study Contacts

Dmitry Shamenkov

CONTACT

+351 910 825 243; ds.shamenkov@ensp.unl.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Researchers responsible for participant enrolment and data collection remain blinded to the randomization sequence until after the completion of the study. Allocation concealment is maintained by securely storing the randomization sequence and ensuring that access is restricted to an authorised expert. Only the authorised expert will participate in generating random allocation and securing the data until the intervention phase is complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: The intervention group will immediately be granted 30 days of access to the Platform and its resources (see 3.4.). 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.

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 11, 2025
• Study Start: January 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-11

Locations

PT (1)