NCT02680444

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

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, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
Last Updated

February 11, 2016

Status Verified

February 1, 2016

Enrollment Period

1.7 years

First QC Date

February 4, 2016

Last Update Submit

February 8, 2016

Conditions

Keywords

MindfulnessPrimary PromotionMental HealthWell-beingPositive Reappraisal

Outcome Measures

Primary Outcomes (1)

  • Change in Daily Affect

    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

Study Arms (3)

Reappraisal-Only Intervention

EXPERIMENTAL

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.

Behavioral: Self-Administered Reappraisal-Only Exercise

Mindful-Reappraisal Intervention

EXPERIMENTAL

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.

Behavioral: Self-Administered Mindful-Reappraisal Exercise

Event Recall Active Control

ACTIVE COMPARATOR

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.

Behavioral: Self-Administered Event Recall Exercise

Interventions

Combining the practice of mindful acceptance of negative events combined with a reappraisal of the event by examining its positive aspects.

Mindful-Reappraisal Intervention

A reappraisal of daily negative events by examining the positive aspects.

Reappraisal-Only Intervention

Recall a negative event that took place that day.

Event Recall Active Control

Eligibility Criteria

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

You may qualify if:

  • Undergraduate students

You may not qualify if:

  • Not undergraduate students

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • M. Gloria Gonzalez-Morales

    University of Guelph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Graduate Researcher

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 11, 2016

Study Start

February 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

February 11, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be available.