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Mindfulness Therapy for Generalised Anxiety in Young Adults
- BDCTR ID
- BDCTR-2026-000098
- Sponsor
- Bangladesh Medical University
- Information provided by
- Dr Mahmudul Karim (Responsible Party)
- Last Update Posted
- 2026-07-20
Not yet recruiting
Study Record Versions
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| Select | Version | Date submitted (YYYY-MM-DD) | Changes |
|---|---|---|---|
| 1 | 2026-07-20Current |
|
Select two versions to compare.
Viewing V1 (2026-07-20)
Study Details
Study Identification
| Unique Protocol ID | BMU-PSY-2026-002 |
|---|---|
| Brief Title | Mindfulness Therapy for Generalised Anxiety in Young Adults |
| Official Title | An Eight-week Group Mindfulness Programme Versus Waitlist Control for Generalised Anxiety Disorder in Young Adults |
| Secondary IDs |
Study Status
| Record Verification | 2026-07 |
|---|---|
| Overall Status | Not yet recruiting |
| Study Start | 2026-11-15 |
| Primary Completion | 2027-04-30 |
| Study Completion | 2027-06-30 |
| First Submitted | |
| First Submitted that Met QC Criteria | 2026-07-05 |
| First Posted | 2026-07-05 [Actual] |
| Last Update Submitted that Met QC Criteria | 2026-07-20 |
| Last Update Posted | 2026-07-20 [Actual] |
Sponsor/Collaborators
| Sponsor | Bangladesh Medical University |
|---|---|
| Responsible Party | Dr Mahmudul Karim |
| Collaborators |
Oversight
| U.S. FDA-regulated Drug | |
|---|---|
| U.S. FDA-regulated Device | |
| Product manufactured in and exported from the U.S. | |
| Data Monitoring | No |
Study Description
| Brief Summary | This trial evaluates an eight-week group mindfulness programme compared with a waitlist control for generalised anxiety in young adults. |
|---|---|
| Detailed Description | Participants with generalised anxiety disorder are randomised to the mindfulness programme or a waitlist. The primary endpoint is change in GAD-7 score at eight weeks. |
Conditions
| Condition | Generalised Anxiety Disorder |
|---|---|
| Keywords | anxiety mindfulness mental health young adults |
Study Design
| Study Type | Interventional |
|---|---|
| Primary Purpose | Treatment |
| Study Phase | N/A |
| Interventional Study Model | Parallel Assignment |
| Number of Arms | 2 |
| Masking | Single blind |
| Allocation | Randomized |
| Enrollment | 260 [Estimated] |
Arms and Interventions
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group mindfulness | Behavioral: Group mindfulness-based therapy Eight weekly facilitated group sessions. |
| No Intervention: Waitlist control |
Outcome Measures
| Primary Outcome Measures | Change in GAD-7 score Time Frame: 8 weeks |
|---|---|
| Secondary Outcome Measures | Change in PHQ-9 score Time Frame: 8 weeks |
Eligibility
| Minimum Age | 18 Years |
|---|---|
| Maximum Age | 30 Years |
| Ages | 18 Years to 30 Years (Adult) |
| Sex | All |
| Gender-based Eligibility | |
| Gender Eligibility Description | |
| Accepts Healthy Volunteers | No |
| Criteria | <p>Inclusion Criteria:</p><ul><li>Adults aged 18 to 30 years meeting criteria for generalised anxiety disorder.</li></ul><p>Exclusion Criteria:</p><ul><li>Current psychotherapy for anxiety.</li></ul> |
Contacts/Locations
| Central Contact Person | Dr Mahmudul Karim anxiety-mbt@bmu.ac.bd |
|---|---|
| Study Officials | |
| Location | Chattogram, Chattogram, Bangladesh, 4000 Status: Not yet recruiting Facility: Chattogram Medical College |
IPD Sharing
| IPD information | Plan to Share IPD: Not provided |
|---|
References
| Citations | |
|---|---|
| Links | |
| Available IPD/Information |
Document Section
| Documents |
|---|