Comparative effectiveness of Satipaṭṭhāna-based thought purification therapy, mindfulness-based cognitive therapy and treatment as usual in patients with depressive disorders: study protocol for a three-arm parallel-group superiority randomized controlled trial
Nikapitiye Nandarathana, Jay K. Ranjan, Hari S. Asthana, Jai S. Yadav
International Journal of Clinical Trials April 29, 2026 DOI: 10.18203/2349-3259.ijct20261390 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 92 |
| Population | Adults aged 18-45 diagnosed with depressive disorders (HAM-D-17 >8 and ≤24) according to ICD-10 and DSM-5-TR |
| Interventions | Satipaṭṭhāna-based thought purification therapy (SB-TPT) Mindfulness-based cognitive therapy (MBCT) Treatment-as-usual (TAU) |
| Duration | 7-week intervention, 3-month follow-up |
| Measures | HAM-D-17, BDI-II, FFMQ-H, WHOQOL-BREF, RRQ |
| Topics | Depression Meditation |
| Key findings | The trial aims to assess comparative effectiveness of SB-TPT, MBCT, and TAU; no results are reported as this is a protocol. The authors propose it will provide the first randomized evaluation of a structured Satipaṭṭhāna-based intervention for depressive disorders. |
Abstract
Background: Depression is a significant global public health challenge, and mindfulness-based cognitive therapy (MBCT) is an evidence-based secular intervention for depression; however, it incorporates partially Buddhist mindfulness practices. The Satipaṭṭhāna-based thought purification therapy (SB-TPT) is a structured, seven-week intervention that integrates systematic contemplation of the body, feelings, mind, and mental phenomena based on Theravāda Buddhist meditation teachings. This trial aims to assess the comparative effectiveness of SB-TPT, MBCT, and treatment-as-usual (TAU) in adults diagnosed with depressive disorders.
Methods: This study is a parallel-group, three-arm superiority randomized controlled trial. 92 adults aged 18-45 years, who have been diagnosed with depressive disorders (HAM-D-17 >8 and ≤24) according to ICD-10 and DSM-5-TR, will be recruited from a tertiary-care academic psychiatry centre in Varanasi, India. Participants will be randomized (1:1:1) to: SB-TPT plus TAU; MBCT plus TAU; and TAU alone. The primary outcome is change in clinician-rated depressive symptom severity measured by the HAM-D-17. Secondary outcomes include depressive symptoms (BDI-II), mindfulness (FFMQ-H), quality of life (WHOQOL-BREF), and rumination (RRQ). Assessments will be conducted at baseline, post-intervention, and at the 3-month follow-up. Data will be analyzed using repeated-measures analysis of variance and intention-to-treat principles.
Conclusions: This trial will provide the first randomized evaluation of a structured Satipaṭṭhāna-based intervention compared with MBCT and treatment as usual for depressive disorders. Findings may contribute to understanding the clinical effectiveness of traditionally grounded contemplative approaches within contemporary mental health settings.
Trial Registration: Clinical Trials Registry of India (https://ctri.nic.in): CTRI/2025/05/087988. 30 May 2025.