- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02680444
Mindful Positive Reappraisal: a Daily Diary Randomized Controlled Trial (Reappraisal)
February 8, 2016 updated by: Ekaterina Pogrebtsova
Exploring Daily Affective Changes in University Students With a Mindful Positive Reappraisal Intervention: a Daily Diary Randomized Controlled Trial
Brief and cost-effective interventions teaching emotion regulation techniques can be feasibly applied to promote mental health in University students.
The tools of mindfulness (i.e., objective awareness and acceptance) and positive reappraisal (i.e., positive re-evaluation of negative events) can mutually benefit one another to promote well-being.
The current study explored the effects of a randomly-assigned Mindful-Reappraisal intervention (n=36) compared to Reappraisal-Only (n=34) and an active control (n=36) on university students' daily affect over five days.
Time by condition interactions were analyzed with planned contrasts and multilevel growth modelling.
Study Overview
Status
Completed
Conditions
Detailed Description
The University student lifestyle can lead to heightened stress, anxiety, and burnout.
To promote mental health, brief and cost-effective interventions teaching beneficial emotion regulation techniques can not only counteract the negative but also foster positive functioning.
The tools of mindfulness (i.e., objective awareness and acceptance) and positive reappraisal (i.e., positive re-evaluation of negative events) can mutually benefit one another to promote well-being.
However, there is currently little research testing the viability of brief, self-administered interventions combining training of mindfulness and positive reappraisal.
The current study explored the effects of a randomly-assigned Mindful-Reappraisal intervention (n=36) compared to Reappraisal-Only (n=34) and an active control (n=36) on university students' daily affect over five days.
Time by condition interactions were analyzed with planned contrasts and multilevel growth modelling.
Study Type
Interventional
Enrollment (Actual)
129
Phase
- Not Applicable
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Undergraduate students
Exclusion Criteria:
- Not undergraduate students
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Reappraisal-Only Intervention
Participants were instructed to independently practice the Self-Administered Reappraisal-Only Exercise in the evening for five days.
First, participants recalled a negative event from that day and then followed the positive reappraisal instructions available online.
This involved thinking about how one could grow, learn or benefit from the negative event in any way possible.
|
A reappraisal of daily negative events by examining the positive aspects.
|
Experimental: Mindful-Reappraisal Intervention
Participants were instructed to independently practice the Self-Administered Mindful-Reappraisal Exercise in the evening for five days.
First, participants recalled a negative event from that day and then followed the Mindful-Reappraisal instructions available online.
This involved thinking about the negative event in an objective, non-judgmental way, then following the Reappraisal-Only instructions, and closing off with a brief mindfulness breathing technique.
|
Combining the practice of mindful acceptance of negative events combined with a reappraisal of the event by examining its positive aspects.
|
Active Comparator: Event Recall Active Control
Participants were instructed to independently practice the Self-Administered Event Recall Exercise in the evening for five days.
In this condition, participants were only instructed to recall a negative event from that day with no reappraisal exercise.
|
Recall a negative event that took place that day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Daily Affect
Time Frame: Day 1 - Day 5 of the intervention practice days
|
Daily affect was measured with two scales (i.e., positive affect and negative affect) and assessed participants' general affect over the past 24 hours.
|
Day 1 - Day 5 of the intervention practice days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: M. Gloria Gonzalez-Morales, University of Guelph
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, 2012
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
February 4, 2016
First Submitted That Met QC Criteria
February 8, 2016
First Posted (Estimate)
February 11, 2016
Study Record Updates
Last Update Posted (Estimate)
February 11, 2016
Last Update Submitted That Met QC Criteria
February 8, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 11NV038
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be available.
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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