Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456931
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-05-29
Brief Title:
A Pilot Study Comparing the Efficacy of Traditional Buddhist Mindfulness Training Versus Secular Mindfulness-based Cognitive Therapy for Patients Having Residual Depressive Symptoms
Sponsor:
Anuradha Baminiwatta
Organization:
University of Kelaniya
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 spiritualityreligiosity secondary outcomes
3 To investigate whether self-compassion mindfulness and spiritualityreligiosity mediate the effectiveness of the interventions
4 To investigate whether baseline spiritualityreligiosity 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 ie 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 Spiritualityreligiosity BENEFIT scale and Acceptabilityfeasibility 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
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 spiritualityreligiosity secondary outcomes
3 To investigate whether self-compassion mindfulness and spiritualityreligiosity mediate the effectiveness of the interventions
4 To investigate whether baseline spiritualityreligiosity 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 ie 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 Spiritualityreligiosity BENEFIT scale and Acceptabilityfeasibility 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None