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Background <p>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.</p> Methods <p>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&#xa0;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)<b>,</b> 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&#xa0;months, and analyses will be performed using an intention-to-treat approach.</p> Discussion <p>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.</p> Trial registration <p>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 <a href="https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=133110&amp;EncHid=16149.91763&amp;modid=1&amp;compid=19">https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=133110&amp;EncHid=16149.91763&amp;modid=1&amp;compid=19</a>.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年8月1日

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  • Hepsipa Omega Juliet,
  • Syjo Davis,
  • Suvarna Jyothi Kantipudi,
  • Aishwarya M.,
  • Giftlin Elizabeth,
  • Jayashree Ganesan,
  • Kasthuri Divya Gnana Subramani,
  • Karthick Subramanian,
  • Krithika Suresh,
  • Lakshmi Venkatraman,
  • Natarajan Varadharajan,
  • Ragul Ganesh,
  • Ramya Vasu,
  • Rudhra Asaithambi,
  • Vikas Menon,
  • Vijayashree Rajkumar,
  • Padmavati Ramachandran

摘要

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.