NCT06456931

A Pilot Study Comparing the Efficacy of Traditional Buddhist Mindfulness Training Versus Secular Mindfulness-based Cognitive Therapy for Patients Having Residual Depressive Symptoms

Comparing the Efficacy of Traditional Buddhist Mindfulness Training Versus Secular Mindfulness-based Cognitive Therapy for Residual Depressive Symptoms in Patients With Depressive Disorders: a Pilot Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Anuradha Baminiwatta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This interventional study is conducted with the goal of comparing the efficacy of traditional Buddhist mindfulness training versus secular mindfulness based cognitive therapy among patients with depressive disorders. We are also interested in studying how these interventions compare in terms of preventing further relapses of depression. Additionally, this study aims to identify factors that influence the efficacy of this intervention, such as self-report mindfulness, self-compassion, and religiosity.

Detailed description

This study has the following objectives: 1. To investigate whether traditional Buddhist mindfulness training is non-inferior to secular MBCT in reducing depressive symptoms and improving psychological wellbeing (primary outcomes) 2. To compare the effectiveness of the two interventions on self-compassion, mindfulness, and spirituality/religiosity (secondary outcomes) 3. To investigate whether self-compassion, mindfulness, and spirituality/religiosity mediate the effectiveness of the interventions 4. To investigate whether baseline spirituality/religiosity moderates the effectiveness of the interventions 5. To compare the effectiveness of the two interventions in preventing depressive relapse over 6 months and 12 months. This will be a parallel group, randomized controlled trial conducted at Colombo North Teaching Hospital (CNTH), and the Faculty of Medicine, University of Kelaniya and involves interventions conducted over 4 months, followed by 12 months of follow-up. Patients with a history of depressive disorder will be recruited from the Psychiatry Clinic, Colombo North Teaching Hospital. Sample size, calculated for a non-inferiority trial design, is 30 in each group. Simple randomization and allocation concealment using sequentially numbered, opaque, sealed envelopes will be used. Both groups will undergo interventions over 8 weeks, with weekly 2-hour sessions. One group will undergo the novel intervention, i.e., traditional Buddhist mindfulness training. The other group will undergo MBCT. Primary outcomes will be depressive symptom severity (Beck Depression Inventory-II), Psychological wellbeing (WHO-5 Wellbeing Index), and the depressive relapse rate at 6 months and 1 year after completion of intervention. Secondary outcomes include mindfulness (Six-Facet Mindfulness Questionnaire), Self-compassion (Self-compassion scale - short form), Spirituality/religiosity (BENEFIT scale), and Acceptability/feasibility. To establish non-inferiority, the 95% CI of the mean difference will be compared against the non-inferiority margin. Moderator and mediation analyses will be conducted.

Conditions

• Depression Moderate
• Depression Mild

Interventions

Type	Name	Description
BEHAVIORAL	Traditional Buddhist mindfulness	Details are provided in the arm/group descriptions.
BEHAVIORAL	secular mindfulness based cognitive therapy	Details are provided in the arm/group descriptions.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-10-31
• Completion: 2025-10-31
• First posted: 2024-06-13
• Last updated: 2024-06-13

Locations

1 site across 1 country: Sri Lanka