An interventional study of Participation in digital mental health intervention and open peer support platform in Anxiety, Depression and Quality of Life and Quality of Life, sponsored by Universidade Nova de Lisboa. Not yet recruiting at 1 site in Portugal. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Universidade Nova de Lisboa · Not applicable, Interventional, and Treatment
RCT to evaluate the efficacy of a digital mental health intervention platform with open peer support in improving participant quality of life.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 82 is close to the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Universidade Nova de Lisboa is the lead sponsor of 43 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
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
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.
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.
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.
Time frame: 1 month
SWLS
Satisfaction with life assessed using measures such as the Satisfaction with Life Scale (SWLS).
Time frame: 1 month
PSS
Stress levels assessed using the Perceived Stress Scale (PSS).
Time frame: 1 month
GAD-7
Anxiety levels measured using the Generalised Anxiety Disorder 7-item Scale (GAD-7).
Time frame: 1 month
PHQ-9
Depression severity evaluated using the Patient Health Questionnaire 9-item (PHQ-9)
Time frame: 1 month
Social Connectedness
Communitas Scale for assessing social connectedness
Time frame: 1 month
MLQ
Meaning of Life Questionnaire (MLQ).
Time frame: 1 month
Mediator: adherence to platform
Adherence to platform (measured by rate of interaction)
Time frame: 1 month
Mediator: concomitant medication use
Concomitant medication use.
Time frame: 1 month
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Universidade Nova de Lisboa