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

Depression Mild Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06456931
• Other study ID #: P/18/02/2024
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: October 31, 2025

Study information

• Verified date: June 2024
• Source: University of Kelaniya
• Contact: Anuradha Baminiwatta, MBBS, MD
• Phone: +94777959197
• Email: baminiwatta[@]kln.ac.lk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression Mild
• Depression Moderate
• Depressive Disorder

Intervention

Behavioral:
• Traditional Buddhist mindfulness
Details are provided in the arm/group descriptions.
• secular mindfulness based cognitive therapy
Details are provided in the arm/group descriptions.

Locations

Country	Name	City	State
Sri Lanka	Colombo North Teaching Hospital	Ragama	Gampaha

Sponsors (3)

Lead Sponsor	Collaborator
Anuradha Baminiwatta	Curtin University, University of Melbourne

Country where clinical trial is conducted

Sri Lanka, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Depressive symptom severity	Beck Depression Inventory -II Score	Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Primary	Psychological wellbeing	WHO Wellbeing Index - 5 score	Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Primary	Relapses of depression	Depressive relapse rate assessed using Composite International Diagnostic Interview	At 6 months and 1 year after completion of intervention
Secondary	Self-report mindfulness	20-item Six-Facet Mindfulness Questionnaire - Sinhala (Baminiwatta et al. 2022)	Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Secondary	Self-compassion	12-item Self-compassion scale - short form - Sinhala ( De Zoysa et al., 2021)	Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Secondary	Spirituality/religiosity	6-item BENEFIT scale - Sinhala (Xue et al., 2016)	Baseline (T0), Post-intervention (T1) 8 weeks from baseline