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

Официальное название

Effectiveness of the Digital Mental Health Intervention and Open Peer Support Platform in Improving Participant Quality of Life: a Randomised Controlled Trial.

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Primary outcome (WHOQOL-BREF change 0-31) [Срок оценки: 1 month]

Вторичные конечные точки (6)

• SWLS [Срок оценки: 1 month]
• PSS [Срок оценки: 1 month]
• GAD-7 [Срок оценки: 1 month]
• PHQ-9 [Срок оценки: 1 month]
• Social Connectedness [Срок оценки: 1 month]
• MLQ [Срок оценки: 1 month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Португалия · 1 центр

• Nova University of Lisbon — Lisbon

Идентификаторы

NCT: NCT07276451 · 21/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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