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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
82
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.
Nova University of Lisbon
Lisbon, Portugal
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.