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

Anuradha Baminiwatta

Status: Enrolling

Conditions: Depression Mild; Depression Moderate

Treatments: Behavioral: Traditional Buddhist mindfulness; Behavioral: secular mindfulness based cognitive therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06456931

P/18/02/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Traditional Buddhist mindfulness training

Experimental group

Description:

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.

Treatment:

Behavioral: Traditional Buddhist mindfulness

Secular mindfulness based cognitive therapy

Active Comparator group

Description:

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).

Treatment:

Behavioral: secular mindfulness based cognitive therapy