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

NCT ID: NCT06456931

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Traditional Buddhist mindfulness training

This involves an 8-week program with weekly 2-hour sessions, and daily home practice of comparable duration to MBCT, conducted in groups of 15 participants. Sessions will be conducted by a lay mindfulness trainer inside a conference hall. Meditation practice will include sitting meditation, walking meditation, and loving-kindness meditation. In addition to meditation practice, sessions will involve teaching and discussing concepts related to mindfulness from the Pali Canon, placed within the context of fundamental principles of Buddhism. Anecdotes from Buddhist literature will also be used. Additionally, the participants will be given the opportunity to engage in religious rituals of their preference during the sessions. Participants will be encouraged to engage in meditation, along with preferred religious activities for at least 40 minutes a day.

Group Type: EXPERIMENTAL

Traditional Buddhist mindfulness

Intervention Type: BEHAVIORAL

Details are provided in the arm/group descriptions.

Secular mindfulness based cognitive therapy

Secular MBCT groups (each consisting of 15 participants) will undergo the manualized 8-week MBCT program (Segal et al., 2002). Weekly 2-hour sessions will be conducted inside a conference hall at the Faculty of Medicine, University of Kelaniya by the principal investigator who is a senior registrar in psychiatry with over 6 years of personal experience in mindfulness practice. Daily home practice of 40 minutes will be recommended. Guided meditation recordings made in Sinhalese will be provided for home practice. Some cognitive behavioural exercises will be prescribed as part of homework (e.g., Pleasant and Unpleasant Events Calendars).

Group Type: ACTIVE_COMPARATOR

secular mindfulness based cognitive therapy

Intervention Type: BEHAVIORAL

Details are provided in the arm/group descriptions.

Interventions

Traditional Buddhist mindfulness

Details are provided in the arm/group descriptions.

Intervention Type: BEHAVIORAL

secular mindfulness based cognitive therapy

Details are provided in the arm/group descriptions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18 or above
• Buddhist faith (Only Buddhists are selected as one of the interventions involves Buddhist teachings, and any recruited participant has a probability of being enrolled in the Buddhist mindfulness intervention)
• A history of one or more episodes of moderate or severe depression
• Currently having BDI-II score > 13, i.e., mild to moderate depressive symptoms

Exclusion Criteria

• Currently having a severe depressive episode, according to the Composite International Diagnostic Interview (CIDI) Sinhalese version
• Currently having moderate to severe suicidal ideation (according to CIDI)
• Recent changes in antidepressant medication
• Unable to understand and communicate in Sinhalese

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Curtin University

OTHER

Sponsor Role: collaborator

University of Melbourne

OTHER

Sponsor Role: collaborator

Anuradha Baminiwatta

OTHER

Sponsor Role: lead

Responsible Party

Anuradha Baminiwatta

Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anuradha Baminiwatta, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kelaniya

Locations

Colombo North Teaching Hospital

Ragama, Gampaha, Sri Lanka

Site Status: RECRUITING

Countries

Sri Lanka

Central Contacts

Anuradha Baminiwatta, MBBS, MD

Role: CONTACT

baminiwatta@kln.ac.lk

+94777959197

Miyuru Chandradasa, MBBS, MD, MRCPsych

Role: CONTACT

miyuruc@kln.ac.lk

+94764628833

Facility Contacts

Anuradha Baminiwatta, MBBS, MD

Role: primary

Other Identifiers

P/18/02/2024

Identifier Type: -

Identifier Source: org_study_id