What is the effectiveness of an additional evidence based digital intervention compared to standard care alone in reducing the severity of substance use disorders, enhancing readiness to change and reducing relapse rates among individuals receiving addiction treatment in Galle District, Sri Lanka?

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 substance use disorders.

1. Study setting(s):

National Hospital Galle (Intervention arm) Thalapitiya Substance Clinic, Galle (Control arm) Pilot study: District Hospital Unawatuna

1. Study design and allocation:

Study design: Non-randomized controlled trial Assignment: Parallel design Allocation: Based on treatment site (intervention vs control clinic) Blinding: Single-blinded (outcome assessor)

1. Description of the intervention:

The intervention will be delivered via a mobile-based application platform over a 1-month period.

Frequency: Minimum 3 sessions per week Duration per session: Approximately 10–20 minutes

Components:

a) AI-driven personalized modules

Users input craving level (1–5), emotional state, and context

A rule-based AI system provides real-time coping strategies (e.g., breathing exercises, distraction techniques) Time-based prompts are used during high-risk periods

b) Virtual Reality (VR) modules

Smartphone-compatible VR simulations Includes: Craving management scenarios (trigger exposure) Stress reduction modules (guided relaxation, nature scenes)

c) Telehealth integration

Telephone-based counselling Counselors receive summary engagement data to tailor support

The intervention was developed based on findings from Phase 1, including user literacy, internet access, readiness to change, and identified craving triggers. Control group (standard care): Participants in the control group will receive standard therapy/practice, which includes:

Routine clinical follow-up Pharmacological treatment (if indicated) Psychological counselling

1. Intervention in relation to standard therapy: The intervention is provided in addition to standard care, not as a replacement.

2. Blinding: Outcome assessment will be conducted by an investigator who is blinded to group allocation. Participants and intervention providers will not be blinded due to the nature of the intervention.

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.

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