About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Parallel
Treatments tested in this trial
Traditional Buddhist mindfulness
BehavioralDetails are provided in the arm/group descriptions.
secular mindfulness based cognitive therapy
BehavioralDetails are provided in the arm/group descriptions.
Treatment groups
Trial outcomes
Primary outcomes
Depressive symptom severity
Beck Depression Inventory -II Score
Psychological wellbeing
WHO Wellbeing Index - 5 score
Relapses of depression
Depressive relapse rate assessed using Composite International Diagnostic Interview
Secondary outcomes
Self-report mindfulness
20-item Six-Facet Mindfulness Questionnaire - Sinhala (Baminiwatta et al. 2022)
Self-compassion
12-item Self-compassion scale - short form - Sinhala ( De Zoysa et al., 2021)
Spirituality/religiosity
6-item BENEFIT scale - Sinhala (Xue et al., 2016)
Other outcomes
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).
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.
Sponsors and contacts
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Anuradha Baminiwatta
Lead sponsor
University of Kelaniya
Sponsor institution
Curtin University
Collaborator
University of Melbourne
Collaborator