Depression ModerateNCT06456931
A Pilot Study Comparing the Efficacy of Traditional Buddhist Mindfulness Training Versus Secular Mindfulness-based Cognitive Therapy for Patients Having Residual Depressive Symptoms
A study testing Traditional Buddhist mindfulness and secular mindfulness based cognitive therapy in people with Depression Moderate and Depression Mild, run by Anuradha Baminiwatta at 1 site in Sri Lanka.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression Moderate, Depression Mild
- What is being tested?
- Traditional Buddhist mindfulness and secular mindfulness based cognitive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSri Lanka
- Study dates
- 1 Apr 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Sri Lanka1 site, 1 recruiting
- Recruiting
Colombo North Teaching Hospital
Ragama, Gampaha, 11010
Anuradha Baminiwatta, MBBS, MD
About this study
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
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.
Read the detailed description
This study has the following objectives:
- To investigate whether traditional Buddhist mindfulness training is non-inferior to secular MBCT in reducing depressive symptoms and improving psychological wellbeing (primary outcomes)
- To compare the effectiveness of the two interventions on self-compassion, mindfulness, and spirituality/religiosity (secondary outcomes)
- To investigate whether self-compassion, mindfulness, and spirituality/religiosity mediate the effectiveness of the interventions
- To investigate whether baseline spirituality/religiosity moderates the effectiveness of the interventions
- 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.
- Conditions
- Depression Moderate, Depression Mild
- Being tested
- Traditional Buddhist mindfulness, secular mindfulness based cognitive therapy
- Keywords
- mindfulness, depression, religiosity
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Buddhist mindfulnessBehavioural
Details are provided in the arm/group descriptions.
secular mindfulness based cognitive therapyBehavioural
Details are provided in the arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Buddhist mindfulness training | Experimental | This involves an 8-week program with weekly 2-hour sessions, and daily home practice of comparable duration to MBCT, conducted in groups of 15 participants. Sessions will be conducted by a lay mindfulness trainer inside a conference hall. Meditation practice will include sitting meditation, walking meditation, and loving-kindness meditation. In addition to meditation practice, sessions will involve teaching and discussing concepts related to mindfulness from the Pali Canon, placed within the context of fundamental principles of Buddhism. Anecdotes from Buddhist literature will also be used. Additionally, the participants will be given the opportunity to engage in religious rituals of their preference during the sessions. Participants will be encouraged to engage in meditation, along with preferred religious activities for at least 40 minutes a day. Receives: Behavioral: Traditional Buddhist mindfulness |
| Secular mindfulness based cognitive therapy | Active comparator | Secular MBCT groups (each consisting of 15 participants) will undergo the manualized 8-week MBCT program (Segal et al., 2002). Weekly 2-hour sessions will be conducted inside a conference hall at the Faculty of Medicine, University of Kelaniya by the principal investigator who is a senior registrar in psychiatry with over 6 years of personal experience in mindfulness practice. Daily home practice of 40 minutes will be recommended. Guided meditation recordings made in Sinhalese will be provided for home practice. Some cognitive behavioural exercises will be prescribed as part of homework (e.g., Pleasant and Unpleasant Events Calendars). Receives: Behavioral: secular mindfulness based cognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptom severity
Beck Depression Inventory -II Score
Measured: Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Psychological wellbeing
WHO Wellbeing Index - 5 score
Measured: Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Relapses of depression
Depressive relapse rate assessed using Composite International Diagnostic Interview
Measured: At 6 months and 1 year after completion of intervention
Secondary outcomes (3)
Self-report mindfulness
20-item Six-Facet Mindfulness Questionnaire - Sinhala (Baminiwatta et al. 2022)
Measured: Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Self-compassion
12-item Self-compassion scale - short form - Sinhala ( De Zoysa et al., 2021)
Measured: Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Spirituality/religiosity
6-item BENEFIT scale - Sinhala (Xue et al., 2016)
Measured: Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Apr 2024
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression ModerateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anuradha Baminiwatta
- Sponsor type
- University, hospital or other
- Collaborators
- Curtin University, University of Melbourne
- Responsible party
- Sponsor-investigator, Anuradha Baminiwatta, University of Kelaniya
- Investigators
- Anuradha Baminiwatta, MBBS, MD, Principal investigator, University of Kelaniya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456931
- Sponsor's protocol ID
- P/18/02/2024
- Status last verified
- Jun 2024
- First submitted
- 29 May 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD will be shared publicly on Figshare.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06456931
- Acronym / sponsor ID
- P/18/02/2024
- Conditions
- Depression Moderate, Depression Mild
- Keywords
- mindfulness, depression, religiosity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anuradha BaminiwattaUniversity, hospital or other
- Collaborators
- Curtin University, University of Melbourne
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To investigate whether traditional Buddhist mindfulness training is non-inferior to secular MBCT in reducing depressive symptoms and improving psychological wellbeing (primary outcomes)
- To compare the effectiveness of the two interventions on self-compassion, mindfulness, and spirituality/religiosity (secondary outcomes)
- To investigate whether self-compassion, mindfulness, and spirituality/religiosity mediate the effectiveness of the interventions
- To investigate whether baseline spirituality/religiosity moderates the effectiveness of the interventions
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Buddhist mindfulness training | Experimental | Behavioral: Traditional Buddhist mindfulnessThis involves an 8-week program with weekly 2-hour sessions, and daily home practice of comparable duration to MBCT, conducted in groups of 15 participants. Sessions will be conducted by a lay mindfulness trainer inside a conference hall. Meditation practice will include sitting meditation, walking meditation, and loving-kindness meditation. In addition to meditation practice, sessions will involve teaching and discussing concepts related to mindfulness from the Pali Canon, placed within the context of fundamental principles of Buddhism. Anecdotes from Buddhist literature will also be used. Additionally, the participants will be given the opportunity to engage in religious rituals of their preference during the sessions. Participants will be encouraged to engage in meditation, along with preferred religious activities for at least 40 minutes a day. |
| Secular mindfulness based cognitive therapy | Active comparator | Behavioral: secular mindfulness based cognitive therapySecular MBCT groups (each consisting of 15 participants) will undergo the manualized 8-week MBCT program (Segal et al., 2002). Weekly 2-hour sessions will be conducted inside a conference hall at the Faculty of Medicine, University of Kelaniya by the principal investigator who is a senior registrar in psychiatry with over 6 years of personal experience in mindfulness practice. Daily home practice of 40 minutes will be recommended. Guided meditation recordings made in Sinhalese will be provided for home practice. Some cognitive behavioural exercises will be prescribed as part of homework (e.g., Pleasant and Unpleasant Events Calendars). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Buddhist mindfulnessDetails are provided in the arm/group descriptions. | Behavioural | Traditional Buddhist mindfulness training |
| secular mindfulness based cognitive therapyDetails are provided in the arm/group descriptions. | Behavioural | Secular mindfulness based cognitive therapy |
Primary outcome
Depressive symptom severity
Time frame: Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Beck Depression Inventory -II Score
Psychological wellbeing
Time frame: Baseline (T0), Post-intervention (T1) 8 weeks from baseline
WHO Wellbeing Index - 5 score
Relapses of depression
Time frame: At 6 months and 1 year after completion of intervention
Depressive relapse rate assessed using Composite International Diagnostic Interview
3 secondary outcomes
Self-report mindfulness
Time frame: Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Self-compassion
Time frame: Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Spirituality/religiosity
Time frame: Baseline (T0), Post-intervention (T1) 8 weeks from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: Yes. De-identified IPD will be shared publicly on Figshare.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anuradha Baminiwatta, MBBS, MD principal investigator
University of Kelaniya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Buddhist mindfulness and secular mindfulness based cognitive therapy in people with Depression Moderate and Depression Mild, run by Anuradha Baminiwatta at 1 site in Sri Lanka.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anuradha Baminiwatta, MBBS, MD (+94777959197, baminiwatta@kln.ac.lk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptom severity (time frame: Baseline (T0), Post-intervention (T1) 8 weeks from baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.