Depression Mild, Depression Moderate
Conditions
Keywords
mindfulness, depression, religiosity
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.
Interventions
BEHAVIORALTraditional Buddhist mindfulness
Details are provided in the arm/group descriptions.
BEHAVIORALsecular mindfulness based cognitive therapy
Details are provided in the arm/group descriptions.
Sponsors
Anuradha Baminiwatta
Curtin University
University of Melbourne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
As the study involves two psychological/behavioural interventions, it will not be possible to mask the participants, care providers or the investigators. However, most outcomes are based on self-report ratings, and the outcome at the end of the intervention (relapse of depression) will be assessed using telephone interviews by investigators blind to the participant's study arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapses of depression | At 6 months and 1 year after completion of intervention | Depressive relapse rate assessed using Composite International Diagnostic Interview |
| Psychological wellbeing | Baseline (T0), Post-intervention (T1) 8 weeks from baseline | WHO Wellbeing Index - 5 score |
| Depressive symptom severity | Baseline (T0), Post-intervention (T1) 8 weeks from baseline | Beck Depression Inventory -II Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spirituality/religiosity | Baseline (T0), Post-intervention (T1) 8 weeks from baseline | 6-item BENEFIT scale - Sinhala (Xue et al., 2016) |
| Self-report mindfulness | Baseline (T0), Post-intervention (T1) 8 weeks from baseline | 20-item Six-Facet Mindfulness Questionnaire - Sinhala (Baminiwatta et al. 2022) |
| Self-compassion | Baseline (T0), Post-intervention (T1) 8 weeks from baseline | 12-item Self-compassion scale - short form - Sinhala ( De Zoysa et al., 2021) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the intervention | Post-intervention (T1) 8 weeks from baseline | 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 | Post-intervention (T1) 8 weeks from baseline | 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. |
Countries
Sri Lanka
Contacts
Primary ContactAnuradha Baminiwatta, MBBS, MD
Backup ContactMiyuru Chandradasa, MBBS, MD, MRCPsych
Outcome results
None listed