- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03453437
Mindful Self-compassion and Perfectionism
August 16, 2021 updated by: University of Bergen
A Randomized Controlled Trial of a Mindful Self-compassion Intervention to Improve Evaluative Concerns Perfectionism, Depression, Anxiety, and Unhealthy Body Image in College Students
The study is a randomized controlled study.
A total of 200 students will be invited to participate in a 5-session mindful self-compassion course aimed at increasing self-compassion and reducing maladaptive perfectionism, anxiety, depression, and unhealthy body image.
Self-compassion is the ability to show oneself kindness in instances of perceived inadequacy, failure, and suffering by attending to distressing experiences with kindness, mindfulness, and the ability to recognize these as a part of a shared humanity.
Twelve participants will be randomly selected for pre- and post interviews to qualitatively evaluate outcome.
Ten participants with high perfectionistic tendencies will be selected to participate in a narrative life story interview.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators will test four hypotheses:
- At baseline, low levels of maladaptive perfectionism, and lower levels of depression, anxiety and body appreciation - reversed, will be related to greater self-compassion. The investigators expect high level of maladaptive perfectionism to be related to lower baseline self-compassion, higher levels of depression and anxiety and lower levels of body appreciation.
- The intervention, a five session self-compassion intervention, will be sufficient to induce positive changes in perfectionism and psychological symptoms of anxiety, depression and body-appreciation- reversed.
- Changes in self-compassion will co-vary with changes in maladaptive perfectionism and body appreciation.
- Higher baseline levels of maladaptive perfectionism will predict greater gains from the intervention, because perfectionistic students will have greater need for a self-compassion intervention.
Study Type
Interventional
Enrollment (Actual)
379
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hordaland
-
Bergen, Hordaland, Norway, 5020
- University of Bergen
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- College/university students
Exclusion Criteria:
- N/A
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
Receiving no intervention (control groups will be offered the intervention after the experimental group has completed the course)
|
|
Experimental: Active group
Receiving Mindful Self-Compassion intervention
|
Mindful self-compassion is a course developed by Kristin Neff and Christopher Germer designed to cultivate self-compassion as measured by three subcategories: self-kindness, mindfulness, and a sense of common humanity.
This study will shorten the original 8-week course to 5 sessions, and will include interventions and lectures aimed directly toward addressing evaluative concerns perfectionism.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in perfectionism
Time Frame: Baseline (two for control group), one week prior to intervention, every week for four weeks until completion of intervention (including one week after last session), 6 months after intervention
|
Adaptive perfectionism as measured by the "Personal Standards" subscale and maladaptive perfectionism/evaluative concerns perfectionism as measured by "Doubts about Actions" and "Concern over Mistakes" subscales of the Frost Multidimensional Perfectionism Scale.
Personal Standards consists of seven items (6 items for "pure personal standards"), Doubt about Actions consists of four items, and Concern over Mistakes consists of 9 items.
All items are on a 5-point Likert scale ranging from strongly disagree to disagree with higher scores indicating most perfectionistic tendencies.
Full range: 20-100 with higher scores representing more perfectionistic tendencies.
Evaluative concerns perfectionism range: 13-65, higher scores indicate more evaluative concerns perfectionism.
Personal standards range: 7-35 with higher scores indicating higher personal standards.
|
Baseline (two for control group), one week prior to intervention, every week for four weeks until completion of intervention (including one week after last session), 6 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in body image
Time Frame: Baseline (two for control group), one week prior to intervention, one week after last session, 6 months after intervention
|
Body image as measured by the 13 item Body Appreciation Scale consisting of a 5-point Likert scale.
Range: 13-65, lower scores indicating no body appreciation and higher scores indicating greater body appreciation.
|
Baseline (two for control group), one week prior to intervention, one week after last session, 6 months after intervention
|
Change in depressive tendencies
Time Frame: Baseline (two for control group), one week prior to intervention, every week for four weeks until completion of intervention (including one week after last session), 6 months after intervention
|
Depressive tendencies as measured by the 12 item Major Depression Inventory which measures symptoms of depression on a 6-point Likert scale (not at all to all of the time), range: 12-72, with higher scores indicating more symptoms of depression.
|
Baseline (two for control group), one week prior to intervention, every week for four weeks until completion of intervention (including one week after last session), 6 months after intervention
|
Change in anxiety
Time Frame: Baseline (two for control group), one week prior to intervention, every week for four weeks until completion of intervention (including one week after last session), 6 months after intervention
|
Anxiety as measured by the 20 item "trait subscale" of the State and Trait Anxiety Inventory.
The Inventory consists of a 4-point Likert scale (almost never to almost always), range: 20-80, higher scores indicating greater anxiety.
|
Baseline (two for control group), one week prior to intervention, every week for four weeks until completion of intervention (including one week after last session), 6 months after intervention
|
Change in self-compassion
Time Frame: Baseline (two for control group), one week prior to intervention, every week for four weeks until completion of intervention (including one week after last session), 6 months after intervention
|
Assessment of self-compassion with the Self-Compassion Scale short form.Total score range from 12 (no self-compassion) to 60 (high on self-compassion).
Higher values represent greater self-compassion, lower scores indicate no self-compassion.
|
Baseline (two for control group), one week prior to intervention, every week for four weeks until completion of intervention (including one week after last session), 6 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Per-Einar Binder, PhD, University of Bergen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
- Bech P, Rasmussen NA, Olsen LR, Noerholm V, Abildgaard W. The sensitivity and specificity of the Major Depression Inventory, using the Present State Examination as the index of diagnostic validity. J Affect Disord. 2001 Oct;66(2-3):159-64. doi: 10.1016/s0165-0327(00)00309-8.
- Avalos L, Tylka TL, Wood-Barcalow N. The Body Appreciation Scale: development and psychometric evaluation. Body Image. 2005 Sep;2(3):285-97. doi: 10.1016/j.bodyim.2005.06.002. Epub 2005 Aug 26.
- Dundas I, Binder PE, Hansen TGB, Stige SH. Does a short self-compassion intervention for students increase healthy self-regulation? A randomized control trial. Scand J Psychol. 2017 Oct;58(5):443-450. doi: 10.1111/sjop.12385. Epub 2017 Aug 28.
- Frost, R.O., Marten, P., Lahart, C., Rosenblate R. The dimensions of perfectionism. Cognitive Therapy and Research, 14 (1990), pp. 449-468.
- Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., & Jacobs, G. A. (1983). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.
- Chang, E. C., Linn, N. J., Herringshaw, A. J., Sanna, L. J., Fabian, C. G., Pereraa, M. J., & Marchenkoa, V. V. (2011). Understanding the link between perfectionism and adjustment in college students: Examining the role of maximizing. Personality and Individual Differences, 50(7), 1074.
- Neff, K. D. (2003). The development and validation of a scale to measure self-compassion. Self and identity, 2(3), 223-250. doi:10.1080/15298860309027
- Bardone-Cone AM, Sturm K, Lawson MA, Robinson DP, Smith R. Perfectionism across stages of recovery from eating disorders. Int J Eat Disord. 2010 Mar;43(2):139-48. doi: 10.1002/eat.20674.
- Boone L, Soenens B, Luyten P. When or why does perfectionism translate into eating disorder pathology? A longitudinal examination of the moderating and mediating role of body dissatisfaction. J Abnorm Psychol. 2014 May;123(2):412-8. doi: 10.1037/a0036254.
- Wade TD, Tiggemann M. The role of perfectionism in body dissatisfaction. J Eat Disord. 2013 Jan 22;1:2. doi: 10.1186/2050-2974-1-2. eCollection 2013.
- Braun TD, Park CL, Gorin A. Self-compassion, body image, and disordered eating: A review of the literature. Body Image. 2016 Jun;17:117-31. doi: 10.1016/j.bodyim.2016.03.003. Epub 2016 Mar 31.
- Breines, J., Toole, A., Tu, C., & Chen, S. (2014). Self-compassion, body image, and self-reported disordered eating. [Journal; Peer Reviewed Journal]. Self and identity, 13(4), 432-448.
- Kelly AC, Tasca GA. Within-persons predictors of change during eating disorders treatment: An examination of self-compassion, self-criticism, shame, and eating disorder symptoms. Int J Eat Disord. 2016 Jul;49(7):716-22. doi: 10.1002/eat.22527. Epub 2016 Apr 6.
- Kelly AC, Vimalakanthan K, Carter JC. Understanding the roles of self-esteem, self-compassion, and fear of self-compassion in eating disorder pathology: an examination of female students and eating disorder patients. Eat Behav. 2014 Aug;15(3):388-91. doi: 10.1016/j.eatbeh.2014.04.008. Epub 2014 May 10.
- Pisitsungkagarn K, Taephant N, Attasaranya P. Body image satisfaction and self-esteem in Thai female adolescents: the moderating role of self-compassion. Int J Adolesc Med Health. 2014;26(3):333-8. doi: 10.1515/ijamh-2013-0307.
- Albertson, E., Neff, K., & Dill-Shackleford, K. (2015). Self-Compassion and Body Dissatisfaction in Women: A Randomized Controlled Trial of a Brief Meditation Intervention. Mindfulness, 6(3), 444-454. doi:10.1007/s12671-014-0277-3
- Woodfin V, Molde H, Dundas I, Binder PE. A Randomized Control Trial of a Brief Self-Compassion Intervention for Perfectionism, Anxiety, Depression, and Body Image. Front Psychol. 2021 Dec 9;12:751294. doi: 10.3389/fpsyg.2021.751294. eCollection 2021.
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 (Actual)
February 3, 2018
Primary Completion (Actual)
May 14, 2019
Study Completion (Actual)
May 14, 2019
Study Registration Dates
First Submitted
January 16, 2018
First Submitted That Met QC Criteria
March 2, 2018
First Posted (Actual)
March 5, 2018
Study Record Updates
Last Update Posted (Actual)
August 17, 2021
Last Update Submitted That Met QC Criteria
August 16, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UiBMSC2018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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