A Pilot Study Comparing the Efficacy of Traditional Buddhist Mindfulness Training Versus Secular Mindfulness-based Cognitive Therapy for Patients Having Residual Depressive Symptoms
NCT Number: NCT06456931
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression Moderate|Depression Mild
Interventions: BEHAVIORAL: Traditional Buddhist mindfulness|BEHAVIORAL: secular mindfulness based cognitive therapy
Sponsor: Anuradha Baminiwatta
Collaborators: Curtin University|University of Melbourne
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2025-10-31
Locations: Colombo North Teaching Hospital, Ragama, Gampaha, 11010, Sri Lanka

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.

Primary Outcome Measures: 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: 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: 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