- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02062762
Internet-based Stress Reduction Training for Students (IBSR-stud)
March 31, 2015 updated by: Richard Branstrom, Karolinska Institutet
Internet-based Stress Reduction Training for Students - a Pilot Study
The main objective of the current study is to evaluate whether a mindfulness based intervention delivered online can provide an effective resource for increasing psychological well-being among students.
In addition, explore potential mechanisms through which the training lead to improvements by means of mediational analyses, with hypothesized variables like positive/negative affect and attention regulation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Stockholm, Sweden, 171 72
- Karolinsk Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- current student
- have an active e-mail account
- regular use of the internet
Exclusion Criteria:
- non-Swedish speaking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Online-MBSR
8 week mindfulness based stress reduction online
|
8 week mindfulness based stress reduction online
|
ACTIVE_COMPARATOR: Expressive Writing Online
Online distributed expressive writing intervention as active control
|
Online distributed expressive writing intervention as active control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychological well-being
Time Frame: Baseline, Week 8
|
Change over time
|
Baseline, Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression symptoms
Time Frame: Baseline, Week 8
|
Change over time
|
Baseline, Week 8
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health-related behaviors
Time Frame: Baseline, Week 8
|
Change over time in proportion reporting binge drinking of alcohol past week (yes/no), and cigarette smoking past week (yes/no); both assessed though self-report questionnaire items.
|
Baseline, Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard Branstrom, PhD, Karolinska Institutet
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (ACTUAL)
June 1, 2014
Study Completion (ACTUAL)
June 1, 2014
Study Registration Dates
First Submitted
February 10, 2014
First Submitted That Met QC Criteria
February 12, 2014
First Posted (ESTIMATE)
February 14, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
April 1, 2015
Last Update Submitted That Met QC Criteria
March 31, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KI-MBSR-Pilot
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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