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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression Moderate; Depression Mild
• Intervention / Treatment: Behavioral: Traditional Buddhist mindfulness; Behavioral: secular mindfulness based cognitive therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anuradha Baminiwatta, MBBS, MD; Phone Number: +94777959197; Email: baminiwatta@kln.ac.lk
• Study Contact Backup: Name: Miyuru Chandradasa, MBBS, MD, MRCPsych; Phone Number: +94764628833; Email: miyuruc@kln.ac.lk

Study Locations

• Sri Lanka
  • Gampaha
    • Ragama, Gampaha, Sri Lanka, 11010
      • Recruiting
      • Colombo North Teaching Hospital
      • Contact: Anuradha Baminiwatta, MBBS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Traditional Buddhist mindfulness; Details are provided in the arm/group descriptions.
Active Comparator: 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).	Behavioral: secular mindfulness based cognitive therapy; Details are provided in the arm/group descriptions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive symptom severity	Beck Depression Inventory -II Score	Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Psychological wellbeing	WHO Wellbeing Index - 5 score	Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Relapses of depression	Depressive relapse rate assessed using Composite International Diagnostic Interview	At 6 months and 1 year after completion of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-report mindfulness	20-item Six-Facet Mindfulness Questionnaire - Sinhala (Baminiwatta et al. 2022)	Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Self-compassion	12-item Self-compassion scale - short form - Sinhala ( De Zoysa et al., 2021)	Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Spirituality/religiosity	6-item BENEFIT scale - Sinhala (Xue et al., 2016)	Baseline (T0), Post-intervention (T1) 8 weeks from baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the intervention	measured using two items: Item 1 will ask participants to rate their overall satisfaction with the intervention using a 10-point Likert scale ranging from 1 (quite dissatisfied) to 10 (very satisfied). Item 2 will ask participants to rate how helpful they believed the intervention was for them on a scale from 1 (not at all helpful) to 10 (very helpful).	Post-intervention (T1) 8 weeks from baseline
Feasibility of the intervention	Session attendance (i.e., the total number of weekly sessions attended); home practice completion (i.e., number of days that home practice was completed); and retention rates will be used as indicators of feasibility. Home practice will be assessed using a homework record form over the 8-week intervention period. Retention rate will be operationalized as the percentage of enrolled participants who complete the primary outcome assessment, and attend at least 4 out of the 8 sessions.	Post-intervention (T1) 8 weeks from baseline

Collaborators and Investigators

• Sponsor: Anuradha Baminiwatta
• Collaborators: University of Melbourne; Curtin University
• Investigators: Principal Investigator: Anuradha Baminiwatta, MBBS, MD, University of Kelaniya

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: depression; mindfulness; religiosity
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: P/18/02/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified IPD will be shared publicly on Figshare.
• IPD Sharing Time Frame: Prior to the submission of the study findings to a journal
• IPD Sharing Access Criteria: Public

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No