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

ConditionsAnxietyDepression and Quality of LifeQuality of Life
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidade Nova de Lisboa

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Participation in digital mental health intervention and open peer support platform

    Other intervention

    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.

Treatment groups

82 Participants
are divided into 2 treatment groups
Group A: Group 1 (Intervention group)Experimental treatment 1 intervention
Group B: Group 2 (control group)No intervention 0 interventions

Trial outcomes

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.

Time frame
1 month

Secondary outcomes

1

SWLS

Satisfaction with life assessed using measures such as the Satisfaction with Life Scale (SWLS).

Time frame
1 month
2

PSS

Stress levels assessed using the Perceived Stress Scale (PSS).

Time frame
1 month
3

GAD-7

Anxiety levels measured using the Generalised Anxiety Disorder 7-item Scale (GAD-7).

Time frame
1 month
4

PHQ-9

Depression severity evaluated using the Patient Health Questionnaire 9-item (PHQ-9)

Time frame
1 month

Other outcomes

1

Mediator: adherence to platform

Adherence to platform (measured by rate of interaction)

Time frame
1 month
2

Mediator: concomitant medication use

Concomitant medication use.

Time frame
1 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade Nova de Lisboa

Lead sponsor

Source ClinicalTrials.gov

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