Low cost app-based intervention DIALOG+ for anxiety and depression in outpatient psychiatric settings: a pragmatic multisite cluster randomized controlled trial

@article{juliet2026cost,
  title = {{Low cost app-based intervention DIALOG+ for anxiety and depression in outpatient psychiatric settings: a pragmatic multisite cluster randomized controlled trial}},
  author = {Hepsipa Omega Juliet and Syjo Davis and Suvarna Jyothi Kantipudi and Aishwarya M. and Giftlin Elizabeth and Jayashree Ganesan and Kasthuri Divya Gnana Subramani and Karthick Subramanian and Krithika Suresh and Lakshmi Venkatraman and Natarajan Varadharajan and Ragul Ganesh and Ramya Vasu and Rudhra Asaithambi and Vikas Menon and Vijayashree Rajkumar and Padmavati Ramachandran},
  journal = {Trials},
  year = {2026},
  month = aug,
  doi = {10.1186/s13063-026-09871-5},
  url = {https://doi.org/10.1186/s13063-026-09871-5},
  note = {CC BY-NC-ND 4.0},
}

TY  - JOUR
TI  - Low cost app-based intervention DIALOG+ for anxiety and depression in outpatient psychiatric settings: a pragmatic multisite cluster randomized controlled trial
AU  - Hepsipa Omega Juliet
AU  - Syjo Davis
AU  - Suvarna Jyothi Kantipudi
AU  - Aishwarya M.
AU  - Giftlin Elizabeth
AU  - Jayashree Ganesan
AU  - Kasthuri Divya Gnana Subramani
AU  - Karthick Subramanian
AU  - Krithika Suresh
AU  - Lakshmi Venkatraman
AU  - Natarajan Varadharajan
AU  - Ragul Ganesh
AU  - Ramya Vasu
AU  - Rudhra Asaithambi
AU  - Vikas Menon
AU  - Vijayashree Rajkumar
AU  - Padmavati Ramachandran
PY  - 2026
DA  - 2026/08/01
JO  - Trials
DO  - 10.1186/s13063-026-09871-5
UR  - https://doi.org/10.1186/s13063-026-09871-5
AB  - Background: Clinically diagnosed anxiety and depressive disorders are widely recognized as the most common mental health issues in India, affecting approximately 15% of the population. With notable gender disparities, Tamil Nadu has some of the highest depression rates in the nation. Despite the growing burden, countries such as India that fall within the low and middle-income countries (LMICs) continue to struggle with mental health services due to challenges in funding, a lack of qualified practitioners, and obstacles to putting evidence-based treatments like Cognitive Behaviour Therapy (CBT) into practice. Innovative, low-cost, and scalable approaches are required to address this gap. This multisite pragmatic randomized controlled trial (RCT) seeks to assess the feasibility, acceptability, and evaluate the effectiveness of DIALOG+ , a low-cost app-based solution-focused intervention designed to enhance quality of life and reduce mental distress. While previously validated for psychosis and other chronic psychiatric conditions, this study aims to evaluate its potential for individuals with anxiety and depression in outpatient psychiatric services in India.  Methods: A pragmatic multisite randomized controlled trial will be conducted across four outpatient psychiatric settings in Chennai and Puducherry to assess the feasibility, acceptability, and effectiveness of DIALOG+, a low-cost app-based intervention. Adults (18–65 years) with anxiety and/or depressive disorders will be randomly allocated to receive either DIALOG+ together with treatment as usual (TAU) or the DIALOG Scale alongside treatment as usual (TAU) over a 6-month period. The key outcome of this study is the improvement in quality of life, evaluated using the Manchester Short Assessment of Quality of Life (MANSA). Secondary outcomes will include changes in depression and anxiety measured using the Depression, Anxiety, and Stress Scale (DASS-21), Hamilton Depression Rating Scale (HDRS), and Hamilton Anxiety Rating Scale (HAM-A). Feasibility will be assessed through recruitment, retention, and intervention fidelity rates, and acceptability will be explored through interviews with participants and clinicians. Assessments at follow-up will be carried out at 3 and 6 months, and analyses will be performed using an intention-to-treat approach.  Discussion: If feasible, acceptable, and effective, DIALOG+ for clinically diagnosed persons with anxiety and depressive disorders could represent a transformative, scalable solution for improving mental health outcomes in India and similar LMIC contexts.  Trial registration: The study is registered with the Clinical Trial Registry-India (CTRI), and the registration number is CTRI/2025/08/092477. The registration was done on August 6, 2025.The URL of the trial registry record is https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=133110&EncHid=16149.91763&modid=1&compid=19.  Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1186/s13063-026-09871-5.
SN  - 1745-6215
ER  -