DepressionIBSR-studNCT02062762
Internet-based Stress Reduction Training for Students
A study testing Online-MBSR and Expressive Writing Online in people with Depression and Stress, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Stress
- What is being tested?
- Online-MBSR and Expressive Writing Online
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2014to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- current student
- have an active e-mail account
- regular use of the internet
Who cannot join
- non-Swedish speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Depression, Stress
- Being tested
- Online-MBSR, Expressive Writing Online
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online-MBSRBehavioural
8 week mindfulness based stress reduction online
Expressive Writing OnlineBehavioural
Online distributed expressive writing intervention as active control
| Study group | Role | What they receive |
|---|---|---|
| Online-MBSR | Experimental | 8 week mindfulness based stress reduction online Receives: Behavioral: Online-MBSR |
| Expressive Writing Online | Active comparator | Online distributed expressive writing intervention as active control Receives: Behavioral: Expressive Writing Online |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological well-being
Change over time
Measured: Baseline, Week 8
Secondary outcomes (1)
Depression symptoms
Change over time
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Branstrom, Karolinska Institutet
- Investigators
- Richard Branstrom, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062762
- Sponsor's protocol ID
- KI-MBSR-Pilot
- Acronym
- IBSR-stud
- Status last verified
- Mar 2015
- First submitted
- 10 Feb 2014
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kvillemo P, Brandberg Y, Branstrom R. Feasibility and Outcomes of an Internet-Based Mindfulness Training Program: A Pilot Randomized Controlled Trial. JMIR Ment Health. 2016 Jul 22;3(3):e33. doi: 10.2196/mental.5457.
PubMed 27450466
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Stress Reduction Training for Students - a Pilot Study
- ClinicalTrials.gov ID
- NCT02062762
- Acronym / sponsor ID
- IBSR-stud / KI-MBSR-Pilot
- Conditions
- Depression, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online-MBSR | Experimental | Behavioral: Online-MBSR8 week mindfulness based stress reduction online |
| Expressive Writing Online | Active comparator | Behavioral: Expressive Writing OnlineOnline distributed expressive writing intervention as active control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- current student
- have an active e-mail account
- regular use of the internet
Key exclusion criteria (1 listed)
- non-Swedish speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online-MBSR8 week mindfulness based stress reduction online | Behavioural | Online-MBSR |
| Expressive Writing OnlineOnline distributed expressive writing intervention as active control | Behavioural | Expressive Writing Online |
Primary outcome
Psychological well-being
Time frame: Baseline, Week 8
Change over time
1 secondary outcome
Depression symptoms
Time frame: Baseline, Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Derived from this study: PubMed 27450466Kvillemo P, Brandberg Y, Branstrom R. Feasibility and Outcomes of an Internet-Based Mindfulness Training Program: A Pilot Randomized Controlled Trial. JMIR Ment Health. 2016 Jul 22;3(3):e33. doi: 10.2196/mental.5457.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Branstrom, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online-MBSR and Expressive Writing Online in people with Depression and Stress, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological well-being (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02062762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.