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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnuradha Baminiwatta

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Traditional Buddhist mindfulness

    Behavioral

    Details are provided in the arm/group descriptions.

  • secular mindfulness based cognitive therapy

    Behavioral

    Details are provided in the arm/group descriptions.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Traditional Buddhist mindfulness trainingExperimental treatment 1 intervention
Group B: Secular mindfulness based cognitive therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Depressive symptom severity

Beck Depression Inventory -II Score

Time frame
Baseline (T0), Post-intervention (T1) 8 weeks from baseline
2

Psychological wellbeing

WHO Wellbeing Index - 5 score

Time frame
Baseline (T0), Post-intervention (T1) 8 weeks from baseline
3

Relapses of depression

Depressive relapse rate assessed using Composite International Diagnostic Interview

Time frame
At 6 months and 1 year after completion of intervention

Secondary outcomes

1

Self-report mindfulness

20-item Six-Facet Mindfulness Questionnaire - Sinhala (Baminiwatta et al. 2022)

Time frame
Baseline (T0), Post-intervention (T1) 8 weeks from baseline
2

Self-compassion

12-item Self-compassion scale - short form - Sinhala ( De Zoysa et al., 2021)

Time frame
Baseline (T0), Post-intervention (T1) 8 weeks from baseline
3

Spirituality/religiosity

6-item BENEFIT scale - Sinhala (Xue et al., 2016)

Time frame
Baseline (T0), Post-intervention (T1) 8 weeks from baseline

Other outcomes

1

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).

Time frame
Post-intervention (T1) 8 weeks from baseline
2

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.

Time frame
Post-intervention (T1) 8 weeks from baseline

Sponsors and contacts

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Anuradha Baminiwatta

Lead sponsor

University of Kelaniya

Sponsor institution

Curtin University

Collaborator

University of Melbourne

Collaborator