Depressive Self-CriticismNCT02164708
Healthy Student Initiative
A study testing Mindfulness Meditation in people with Depressive Self-Criticism, run by York University at 1 site in Canada.
Trial summary
This paper extends prior research by exploring how students with self-critical (SC) traits respond to mindfulness meditation (MM) with a twofold purpose: i) to study anxiety sensitivity and mood changes during the school year as students attended MM tutorials ii) to study the relationship between self-criticism and… Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Self-Criticism
- What is being tested?
- Mindfulness Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Jul 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Currently enrolled (part-time-full-time) OR current staff members at university
- Computer access at the university or elsewhere and/or smartphone access
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This paper extends prior research by exploring how students with self-critical (SC) traits respond to mindfulness meditation (MM) with a twofold purpose: i) to study anxiety sensitivity and mood changes during the school year as students attended MM tutorials ii) to study the relationship between self-criticism and MM-related benefits over time. This paper reports on participants' mood and anxiety sensitivity changes before, during, and after the MM program and the association between depressed mood and SC levels. Participants were trained in MM over two continuous semesters, with two specific hypotheses guiding evaluations:
- Participants overall would report progressive improvements in psychological well-being as measured by mood and anxiety sensitivity variables, reflecting the effectiveness of the MM program.
- Elevations in self-critical personality traits would predict greater improvements in depressed mood, given the greater need to neutralize cognitive events related to negative moods.
Read the detailed description
A total of 71 undergraduate students in a large public university participated in weekly MM sessions through the Fall \& Winter semesters of the 2012/2013 academic year. Recruitment was facilitated through in-class announcements and poster and print advertisements. Online and paper surveys elicited self-report data (reflecting mental health profiles) at program initiation which served as baseline measures for the September-October study period, written informed consent was also obtained during this time. Inclusion criteria included: 1) currently enrolled (part-time-full-time); 2) computer access at the university or elsewhere and/or smartphone access Following a standard within-subjects design, participants were required to complete the psychological measures at 3 additional assessment periods; Time 2 (November-December), Time 3 (January-February), and Time 4 (March-April). To alleviate demands on the students partaking in weekly MM sessions, follow-up assessments were provided in paper and electronic form and completed autonomously. Study participants were given $50 cash payments for full study participation and the study met the ethical guidelines and received approval from the Human Participants Review Subcommittee of the university site where the study was conducted.
The program progressively trained students in "mindfulness of breathing", a form of meditation frequently employed secularly. The tutorials were held on campus five times weekly, led by a faculty member and a graduate student who were trained, experienced MM practitioners. The tutorials were one hour in duration and typically involved 40-45 minutes of guided MM followed by a question-answer period that addressed recent research findings. Program participation required attendance at one tutorial per week, and participants were encouraged to maintain autonomous MM practice.
- Conditions
- Depressive Self-Criticism
- Being tested
- Mindfulness Meditation
- Keywords
- mindfulness meditation, mental health, self-criticism
- 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.
Mindfulness MeditationBehavioural
The program progressively trained students in "mindfulness of breathing", a form of meditation frequently employed secularly. The tutorials were held on campus five times weekly, led by a faculty member and a graduate student who were trained, experienced MM practitioners. The tutorials were one hour in duration and typically involved 40-45 minutes of guided MM followed by a question-answer period that addressed recent research findings. Program participation required attendance at one tutorial per week, and participants were encouraged to maintain autonomous MM practice.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Meditation | Experimental | The program progressively trained students in "mindfulness of breathing", a form of meditation frequently employed secularly. The tutorials were held on campus five times weekly, led by a faculty member and a graduate student who were trained, experienced MM practitioners. The tutorials were one hour in duration and typically involved 40-45 minutes of guided MM followed by a question-answer period that addressed recent research findings. Program participation required attendance at one tutorial per week, and participants were encouraged to maintain autonomous MM practice. Receives: Behavioral: Mindfulness Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of Mood States
Inventory to assess mood states
Measured: 6 months
Secondary outcomes (1)
Anxiety Sensitivity
Inventory to assess anxiety sensitivity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startJul 2012
- Primary completionJul 2013
- Study completionJul 2013
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 Depressive Self-CriticismStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Economic Development Agency for Southern Ontario
- Responsible party
- Principal investigator, Paul Ritvo, York University
- Investigators
- Paul Ritvo, PhD, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164708
- Sponsor's protocol ID
- 2012 - 170
- Status last verified
- Jun 2014
- First submitted
- 12 Jun 2014
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ritvo, P., Vora, K., Irvine, J., Mongrain, M., Azargive, S., Muhammad Abid, A., … Cribbie, R. (2013). Reductions in Negative Automatic Thoughts in Students Attending Mindfulness Tutorials Predicts Increased Life Satisfaction. International Journal of Educational Psychology, 2(3), 272-296. doi:10.4471/ijep.2013.28
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Student Initiative
- ClinicalTrials.gov ID
- NCT02164708
- Acronym / sponsor ID
- 2012 - 170
- Conditions
- Depressive Self-Criticism
- Keywords
- mindfulness meditation, mental health, self-criticism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Collaborators
- Federal Economic Development Agency for Southern Ontario
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Jun 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.
This paper extends prior research by exploring how students with self-critical (SC) traits respond to mindfulness meditation (MM) with a twofold purpose: i) to study anxiety sensitivity and mood changes during the school year as students attended MM tutorials ii) to study the relationship between self-criticism and MM-related benefits over time. This paper reports on participants' mood and anxiety sensitivity changes before, during, and after the MM program and the association between depressed mood and SC levels. Participants were trained in MM over two continuous semesters, with two specific hypotheses guiding evaluations:
- Participants overall would report progressive improvements in psychological well-being as measured by mood and anxiety sensitivity variables, reflecting the effectiveness of the MM program.
- Elevations in self-critical personality traits would predict greater improvements in depressed mood, given the greater need to neutralize cognitive events related to negative moods.
Detailed description
A total of 71 undergraduate students in a large public university participated in weekly MM sessions through the Fall \& Winter semesters of the 2012/2013 academic year. Recruitment was facilitated through in-class announcements and poster and print advertisements. Online and paper surveys elicited self-report data (reflecting mental health profiles) at program initiation which served as baseline measures for the September-October study period, written informed consent was also obtained during this time. Inclusion criteria included: 1) currently enrolled (part-time-full-time); 2) computer access at the university or elsewhere and/or smartphone access Following a standard within-subjects design, participants were required to complete the psychological measures at 3 additional assessment periods; Time 2 (November-December), Time 3 (January-February), and Time 4 (March-April). To alleviate demands on the students partaking in weekly MM sessions, follow-up assessments were provided in paper and electronic form and completed autonomously. Study participants were given $50 cash payments for full study participation and the study met the ethical guidelines and received approval from the Human Participants Review Subcommittee of the university site where the study was conducted.
The program progressively trained students in "mindfulness of breathing", a form of meditation frequently employed secularly. The tutorials were held on campus five times weekly, led by a faculty member and a graduate student who were trained, experienced MM practitioners. The tutorials were one hour in duration and typically involved 40-45 minutes of guided MM followed by a question-answer period that addressed recent research findings. Program participation required attendance at one tutorial per week, and participants were encouraged to maintain autonomous MM practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation | Experimental | Behavioral: Mindfulness MeditationThe program progressively trained students in "mindfulness of breathing", a form of meditation frequently employed secularly. The tutorials were held on campus five times weekly, led by a faculty member and a graduate student who were trained, experienced MM practitioners. The tutorials were one hour in duration and typically involved 40-45 minutes of guided MM followed by a question-answer period that addressed recent research findings. Program participation required attendance at one tutorial per week, and participants were encouraged to maintain autonomous MM practice. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Currently enrolled (part-time-full-time) OR current staff members at university
- Computer access at the university or elsewhere and/or smartphone access
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Mindfulness MeditationThe program progressively trained students in "mindfulness of breathing", a form of meditation frequently employed secularly. The tutorials were held on campus five times weekly, led by a faculty member and a graduate student who were trained, experienced MM practitioners. The tutorials were one hour in duration and typically involved 40-45 minutes of guided MM followed by a question-answer period that addressed recent research findings. Program participation required attendance at one tutorial per week, and participants were encouraged to maintain autonomous MM practice. | Behavioural | Mindfulness Meditation |
Primary outcome
Profile of Mood States
Time frame: 6 months
Inventory to assess mood states
1 secondary outcome
Anxiety Sensitivity
Time frame: 6 months
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 16 Jun 2014.
- Results publicationRitvo, P., Vora, K., Irvine, J., Mongrain, M., Azargive, S., Muhammad Abid, A., … Cribbie, R. (2013). Reductions in Negative Automatic Thoughts in Students Attending Mindfulness Tutorials Predicts Increased Life Satisfaction. International Journal of Educational Psychology, 2(3), 272-296. doi:10.4471/ijep.2013.28
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.
Paul Ritvo, PhD principal investigator
York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation in people with Depressive Self-Criticism, run by York University at 1 site in Canada.
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 2 inclusion and 0 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 16 Jun 2014. 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 Canada. 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?
Profile of Mood States (time frame: 6 months). 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 NCT02164708, 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 16 Jun 2014.