Mental Health Wellness 1ReappraisalNCT02680444
Mindful Positive Reappraisal: a Daily Diary Randomized Controlled Trial
A study testing Self-Administered Mindful-Reappraisal Exercise, Self-Administered Reappraisal-Only Exercise and Self-Administered Event Recall Exercise in people with Mental Health Wellness 1, run by Ekaterina Pogrebtsova.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Self-Administered Mindful-Reappraisal Exercise, Self-Administered Reappraisal-Only Exercise and Self-Administered Event Recall Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Oct 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Undergraduate students
Who cannot join
- Not undergraduate students
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health Wellness 1
- Being tested
- Self-Administered Mindful-Reappraisal Exercise, Self-Administered Reappraisal-Only Exercise, Self-Administered Event Recall Exercise
- Keywords
- Mindfulness, Primary Promotion, Mental Health, Well-being, Positive Reappraisal
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Administered Mindful-Reappraisal ExerciseBehavioural
Combining the practice of mindful acceptance of negative events combined with a reappraisal of the event by examining its positive aspects.
Self-Administered Reappraisal-Only ExerciseBehavioural
A reappraisal of daily negative events by examining the positive aspects.
Self-Administered Event Recall ExerciseBehavioural
Recall a negative event that took place that day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Self-Administered Event Recall Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 - Day 5 of the intervention practice days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startFeb 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ekaterina Pogrebtsova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ekaterina Pogrebtsova, University of Guelph
- Investigators
- M. Gloria Gonzalez-Morales, Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680444
- Sponsor's protocol ID
- 11NV038
- Acronym
- Reappraisal
- Status last verified
- Feb 2016
- First submitted
- 4 Feb 2016
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be available.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Daily Affective Changes in University Students With a Mindful Positive Reappraisal Intervention: a Daily Diary Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02680444
- Acronym / sponsor ID
- Reappraisal / 11NV038
- Conditions
- Mental Health Wellness 1
- Keywords
- Mindfulness, Primary Promotion, Mental Health, Well-being, Positive Reappraisal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Ekaterina PogrebtsovaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 11 Feb 2016 (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.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reappraisal-Only Intervention | Experimental | Behavioral: Self-Administered Reappraisal-Only ExerciseParticipants 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. |
| Mindful-Reappraisal Intervention | Experimental | Behavioral: Self-Administered Mindful-Reappraisal ExerciseParticipants 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. |
| Event Recall Active Control | Active comparator | Behavioral: Self-Administered Event Recall ExerciseParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Undergraduate students
Key exclusion criteria (1 listed)
- Not undergraduate students
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 |
|---|---|---|
| Self-Administered Mindful-Reappraisal ExerciseCombining the practice of mindful acceptance of negative events combined with a reappraisal of the event by examining its positive aspects. | Behavioural | Mindful-Reappraisal Intervention |
| Self-Administered Reappraisal-Only ExerciseA reappraisal of daily negative events by examining the positive aspects. | Behavioural | Reappraisal-Only Intervention |
| Self-Administered Event Recall ExerciseRecall a negative event that took place that day. | Behavioural | Event Recall Active Control |
Primary outcome
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.
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 11 Feb 2016.
- Individual participant dataSharing planned: No. Individual participant data will not be available.
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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.
M. Gloria Gonzalez-Morales principal investigator
University of Guelph
Questions about this trial
What is this clinical trial studying?
A study testing Self-Administered Mindful-Reappraisal Exercise, Self-Administered Reappraisal-Only Exercise and Self-Administered Event Recall Exercise in people with Mental Health Wellness 1, run by Ekaterina Pogrebtsova.
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 1 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 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Daily Affect (time frame: Day 1 - Day 5 of the intervention practice days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2016.