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Effectiveness of an AI-driven virtual reality digital intervention plus standard care versus standard care alone for Substance Use Disorders in Galle District, Sri Lanka

(APPL/2026/006) Digital Therapeutics for Addiction Management: Development and Evaluation of the Effectiveness of a Virtual Reality and AI-Driven Intervention for Substance Use Disorders in Galle District, Sri Lanka

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2026/018
Enrollment
Unknown
Registered
2026-07-18
Start date
2026-09-25
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use Disorders

Interventions

The intervention is a digital therapeutic program combining AI-driven personalized modules, virtual reality (VR)-based simulations, and telehealth support, delivered in addition to standard care for s

Sponsors

Faculty of Medicine, University of Ruhuna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants will be defined as individuals diagnosed with Substance Use Disorder according to DSM-5 criteria, confirmed by a qualified psychiatrist. All participants will be assessed at recruitment to ensure they meet diagnostic criteria.

Exclusion criteria

Exclusion criteria: 1.Individuals with severe comorbid medical conditions that may interfere with treatment or data collection 2.Individuals with severe comorbid psychiatric conditions that may interfere with treatment or data collection. (e.g., psychosis, severe depression with suicidality) and severe medical illnesses as identified by a consultant psychiatrist. 3.Individuals who are unable or unwilling to comply with the study protocols, including those who do not complete the required assessments or follow-ups 4.Individuals with significant cognitive impairments that prevent them from understanding the study procedures or providing informed consent. Cognitive impairment will be identified through clinical assessment with use of brief tools such as MMSE where necessary. 5.Persons who have undergone other forms of intervention for substance use within the six months prior to the study 6.Individuals without access to required technology and who lack the digital literacy to participate

Design outcomes

Primary

MeasureTime frame
Relapse Rate: Incidence of relapse as measured by (1) Self-reported substance use (2) Clinical follow-up records from the outpatient clinic (3) App based relapse reporting [Relapse rate at 3 and 6 months ]

Secondary

MeasureTime frame
Readiness to Change: Assessed through the DUDIT-E questionnaire Changes in readiness stages will be evaluated using pre-post comparisons. [At baseline, 3 and 6 month] [At 3 and 6 months from recruitment] Engagement with Intervention: Frequency and duration of interactions with the AI-driven modules and VR simulations will be tracked via the app using number of logins, module completion rates, and time spent on the application (minutes per week). Higher engagement rates will be correlated with better addiction management outcomes. [At 3 and 6 months from recruitment]

Countries

Sri Lanka

Contacts

Public ContactManikku Patabandige Sudarshani

Acting consultant psychiatrist

sudarshanipatabandige@gmail.com±94718762987

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 10, 2026