Clinical trial NCT06456931: A Pilot Study Comparing the Efficacy of Traditional Buddhist Mindfulness Training Versus Secular Mindfulness-based Cognitive Therapy for Patients Having Residual Depressive Symptoms
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression Moderate
Depression Mild
Keywords: mindfulness
depression
religiosity
Lead sponsor: University of Kelaniya
Sponsor class: OTHER
Collaborators: name: Curtin University
name: University of Melbourne
First posted: 2024-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Depressive symptom severity
timeFrame: Baseline (T0), Post-intervention (T1) 8 weeks from baseline
measure: Psychological wellbeing
timeFrame: Baseline (T0), Post-intervention (T1) 8 weeks from baseline
measure: Relapses of depression
timeFrame: At 6 months and 1 year after completion of intervention
Secondary outcomes:
measure: Self-report mindfulness
timeFrame: Baseline (T0), Post-intervention (T1) 8 weeks from baseline
measure: Self-compassion
timeFrame: Baseline (T0), Post-intervention (T1) 8 weeks from baseline
measure: Spirituality/religiosity
timeFrame: Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Other outcomes:
measure: Acceptability of the intervention
timeFrame: Post-intervention (T1) 8 weeks from baseline
measure: Feasibility of the intervention
timeFrame: Post-intervention (T1) 8 weeks from baseline
Locations:
city: Ragama
country: Sri Lanka
facility: Colombo North Teaching Hospital
state: Gampaha
Study officials:
affiliation: University of Kelaniya
name: Anuradha Baminiwatta, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: