NCT02062762

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable depression

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

February 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

4 months

First QC Date

February 10, 2014

Last Update Submit

March 31, 2015

Conditions

DepressionStress

Outcome Measures

Primary Outcomes (1)

  • Psychological well-being

    Change over time

    Baseline, Week 8

Secondary Outcomes (1)

  • Depression symptoms

    Baseline, Week 8

Other Outcomes (1)

  • Health-related behaviors

    Baseline, Week 8

Study Arms (2)

Online-MBSR

EXPERIMENTAL

8 week mindfulness based stress reduction online

Behavioral: Online-MBSR

Expressive Writing Online

ACTIVE COMPARATOR

Online distributed expressive writing intervention as active control

Behavioral: Expressive Writing Online

Interventions

Online-MBSRBEHAVIORAL

8 week mindfulness based stress reduction online

Online-MBSR
Expressive Writing OnlineBEHAVIORAL

Online distributed expressive writing intervention as active control

Expressive Writing Online

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • current student
  • have an active e-mail account
  • regular use of the internet

You may not qualify if:

  • non-Swedish speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinsk Institute

Stockholm, Stockholm County, 171 72, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 27450466DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Richard Branstrom, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 10, 2014

First Posted

February 14, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

SE(1)