NCT06156852

Brief Summary

We aimed to compare the effects of the Mindfulness-Based Stress Reduction (MBSR) and the Cognitive Behavioural Stress Reduction (CBSR) group interventions on depression and anxiety symptoms and perceived stress of medical students. 323 medical students applied to participate in one of the group interventions and were assessed with the Mini International Neuropsychiatric Interview. Of these, 253 (77% female, mean age=21.9 ± 2.9 years) were allocated into online MBSR (n=127) and online CBSR (n=126) groups after randomization. Their anxiety and depressive symptoms and perceived stress levels were assessed at baseline and after 8 weeks of interventions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
253

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

November 27, 2023

Last Update Submit

November 27, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Perceived stress level

    Perceived stress levels were assessed with the Perceived Stress Scale (PSS). This is a widely used scale to assess the effects of different situations on our emotions and perceived stress.

    8 weeks

  • Anxiety level

    Anxiety symptom levels were assessed with the Hospital anxiety and depression scale (HADS). This scale is a self-assessment scale developed to determine the risk of anxiety and depression in patients with physical illness and primary health care patients and to measure their level and change in severity.

    8 weeks

  • Depressive symptom level

    Depressive symptom levels were assessed with the Hospital anxiety and depression scale (HADS). This scale is a self-assessment scale developed to determine the risk of anxiety and depression in patients with physical illness and primary health care patients and to measure their level and change in severity.

    8 weeks

Study Arms (2)

Mindfulness-based stress reduction group (MBSR)

ACTIVE COMPARATOR

Medical faculty students who volunteered to participate in the study were assessed by a senior psychiatry resident. The students who were found to be eligible to take part in the study were randomized to two groups (MBSR and CBSR groups).

Other: Mindfulness-based stress reduction group

Cognitive behavioral based stress reduction group (CBSR)

ACTIVE COMPARATOR

Medical faculty students who volunteered to participate in the study were assessed by a senior psychiatry resident. The students who were found to be eligible to take part in the study were randomized to two groups (MBSR and CBSR groups).

Other: Cognitive behavioral-based stress reduction group

Interventions

Mindfulness-based stress reduction (MBSR) group interventions were implemented for eight weeks.

Mindfulness-based stress reduction group (MBSR)

Cognitive behavioral-based stress reduction group interventions were implemented for eight weeks.

Cognitive behavioral based stress reduction group (CBSR)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being a medical student at a university in Ankara
  • Being older than 18 years old
  • Not having participated in mindfulness-based or cognitive behavioral stress reduction groups or individual therapies
  • Volunteering to participate in the study

You may not qualify if:

  • Having known mindfulness-based stress reduction methods and applied them in their lives
  • Having known cognitive behavioral stress reduction methods and applied them in their lives
  • Depression and mania severe enough to prevent their participation in the study
  • High risk of suicide
  • Having a chronic physical condition that may prevent participation in the study
  • History of psychotic disorder and/or meeting the diagnosis of psychotic disorder at the assessment stage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayşegül Yay Pençe

Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Selçuk Aslan, MD

    Gazi University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

November 27, 2023

First Posted

December 5, 2023

Study Start

April 1, 2022

Primary Completion

December 30, 2022

Study Completion

June 15, 2023

Last Updated

December 5, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations