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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

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Trial Contacts

Dr Mahmudul Karim

anxiety-mbt@bmu.ac.bd

Study Record Dates

First SubmittedICMJE	Not provided
First PostedICMJE	2026-07-05
Last Update Posted	2026-07-20
Last Verified*	2026-07

Outcome Measures

Primary Outcome Measures*ICMJE	Change in GAD-7 score [Time Frame: 8 weeks]
Secondary Outcome Measures[*]ICMJE	Change in PHQ-9 score [Time Frame: 8 weeks]
Other Pre-specified Outcome Measures	Not provided

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Trial Description

Brief Title*ICMJE	Mindfulness Therapy for Generalised Anxiety in Young Adults
Official Title*§ICMJE	An Eight-week Group Mindfulness Programme Versus Waitlist Control for Generalised Anxiety Disorder in Young Adults
Acronym[*]	Not provided
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.
Study Type*ICMJE	Interventional
Study Phase*ICMJE	N/A
Study Design*§ICMJE	Allocation: Randomized Interventional Model: Parallel Assignment Masking: Single blind Primary Purpose: Treatment
Condition*ICMJE	Generalised Anxiety Disorder
Keywords	anxiety mindfulness mental health young adults
Intervention*ICMJE	Behavioral: Group mindfulness-based therapy — Eight weekly facilitated group sessions.
Study Arms*ICMJE	Experimental: Group mindfulness Interventions: Behavioral: Group mindfulness-based therapy No Intervention: Waitlist control
Publications	Not provided

Recruitment Information

Recruitment Status*ICMJE	Not yet recruiting
Enrollment (Anticipated)*§ICMJE	260
Study Start Date*§ICMJE	2026-11-15
Primary Completion Date*	2027-04-30 (Final data collection date for primary outcome measure)
Study Completion Date*§ICMJE	2027-06-30
Eligibility Criteria*ICMJE	<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>
Sex/Gender*ICMJE	Sexes Eligible for Study: All
Ages*ICMJE	18 Years to 30 Years (Adult)
Accepts Healthy Volunteers*§ICMJE	No
Location CountriesICMJE	Bangladesh

Administrative Information

BDCTR NumberICMJE	BDCTR-2026-000098
Other Study ID Numbers[*]ICMJE	BMU-PSY-2026-002
Has Data Monitoring Committee	No
Studies a U.S. FDA-regulated Drug Product	Not provided
Studies a U.S. FDA-regulated Device Product	Not provided
Device Product Not Approved or Cleared by U.S. FDA	Not provided
Pediatric Postmarket Surveillance of a Device Product	Not provided
Product Manufactured in and Exported from the U.S.	Not provided
IPD Sharing StatementICMJE	Plan to Share IPD: Not provided
Current Responsible Party*	Dr Mahmudul Karim
Current Study Sponsor*ICMJE	Bangladesh Medical University
CollaboratorsICMJE	Not provided
InvestigatorsICMJE	Not provided
Registry Account	Imported legacy public registry

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*: Required
*§: Required if Study Start Date is on or after January 18, 2017 — required for every BMU study
[*]: Conditionally required
No Symbol: Unmarked fields are optional. If no information is provided, fields will be labeled as “Not provided”.
ICMJE: Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP