AnxietyNCT07276451
Effectiveness of the DMHI and OPS Platform in Improving Participant QOL: a Randomised Controlled Trial.
A study testing Participation in digital mental health intervention and open peer support platform in people with Anxiety and Depression and Quality of Life, run by Universidade Nova de Lisboa at 1 site in Portugal.
Trial summary
RCT to evaluate the efficacy of a digital mental health intervention platform with open peer support in improving participant quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression and Quality of Life, Quality of Life
- What is being tested?
- Participation in digital mental health intervention and open peer support platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of the Digital Mental Health Intervention and Open Peer Support Platform in Improving Participant Quality of Life: a Randomised Controlled Trial.
RCT to evaluate the efficacy of a digital mental health intervention platform with open peer support in improving participant quality of life.
Read the 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
- Being tested
- Participation in digital mental health intervention and open peer support platform
- Keywords
- digital mental health intervention, open peer support, mental health, online support
- Medical subject headings
- Anxiety Disorders, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participation in digital mental health intervention and open peer support platformOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (6)
SWLS
Satisfaction with life assessed using measures such as the Satisfaction with Life Scale (SWLS).
Measured: 1 month
PSS
Stress levels assessed using the Perceived Stress Scale (PSS).
Measured: 1 month
GAD-7
Anxiety levels measured using the Generalised Anxiety Disorder 7-item Scale (GAD-7).
Measured: 1 month
PHQ-9
Depression severity evaluated using the Patient Health Questionnaire 9-item (PHQ-9)
Measured: 1 month
Social Connectedness
Communitas Scale for assessing social connectedness
Measured: 1 month
MLQ
Meaning of Life Questionnaire (MLQ).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmitry Shamenkov, Universidade Nova de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276451
- Sponsor's protocol ID
- 21/2025
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Digital Mental Health Intervention and Open Peer Support Platform in Improving Participant Quality of Life: a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT07276451
- Acronym / sponsor ID
- 21/2025
- Conditions
- Anxiety, Depression and Quality of Life, Quality of Life
- Keywords
- digital mental health intervention, open peer support, mental health, online support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Intervention group) | Experimental | Other: Participation in digital mental health intervention and open peer support platformIntervention 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 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participation in digital mental health intervention and open peer support platformParticipants 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. | Other | Group 1 (Intervention group) |
Primary outcome
Primary outcome (WHOQOL-BREF change 0-31)
Time frame: 1 month
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.
6 secondary outcomes
SWLS
Time frame: 1 month
PSS
Time frame: 1 month
GAD-7
Time frame: 1 month
PHQ-9
Time frame: 1 month
Social Connectedness
Time frame: 1 month
MLQ
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participation in digital mental health intervention and open peer support platform in people with Anxiety and Depression and Quality of Life, run by Universidade Nova de Lisboa at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dmitry Shamenkov (+351 910 825 243, ds.shamenkov@ensp.unl.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (WHOQOL-BREF change 0-31) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.