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

NCT06456931 | Recruiting DMC

• 1 other identifier: P/18/02/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression Moderate; Depression Mild

Keywords

mindfulness; depression; religiosity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Self-report mindfulness

  Baseline (T0), Post-intervention (T1) 8 weeks from baseline

• Self-compassion

  Baseline (T0), Post-intervention (T1) 8 weeks from baseline

• Spirituality/religiosity

  Baseline (T0), Post-intervention (T1) 8 weeks from baseline

Other Outcomes (2)

• Acceptability of the intervention

  Post-intervention (T1) 8 weeks from baseline

• Feasibility of the intervention

  Post-intervention (T1) 8 weeks from baseline

Study Arms (2)

Traditional Buddhist mindfulness training

EXPERIMENTAL

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

Secular mindfulness based cognitive therapy

ACTIVE COMPARATOR

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

Interventions

Traditional Buddhist mindfulness BEHAVIORAL

Details are provided in the arm/group descriptions.

Traditional Buddhist mindfulness training

secular mindfulness based cognitive therapy BEHAVIORAL

Details are provided in the arm/group descriptions.

Secular mindfulness based cognitive therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anuradha Baminiwatta: lead
• Curtin University: collaborator
• University of Melbourne: collaborator

Study Sites (1)

Colombo North Teaching Hospital

Ragama, Gampaha, 11010, Sri Lanka

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Anuradha Baminiwatta, MBBS, MD

  University of Kelaniya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anuradha Baminiwatta, MBBS, MD

CONTACT

+94777959197; baminiwatta@kln.ac.lk

Miyuru Chandradasa, MBBS, MD, MRCPsych

CONTACT

+94764628833; miyuruc@kln.ac.lk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: As the study involves two psychological/behavioural interventions, it will not be possible to mask the participants, care providers or the investigators. However, most outcomes are based on self-report ratings, and the outcome at the end of the intervention (relapse of depression) will be assessed using telephone interviews by investigators blind to the participant's study arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 13, 2024
• Study Start: April 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Prior to the submission of the study findings to a journal
• Access Criteria: Public

Locations

SR (1)