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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03453437
Other study ID # UiBMSC2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 3, 2018
Est. completion date May 14, 2019

Study information

Verified date August 2021
Source University of Bergen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The investigators will test four hypotheses: 1. 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. 2. 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. 3. Changes in self-compassion will co-vary with changes in maladaptive perfectionism and body appreciation. 4. 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.


Recruitment information / eligibility

Status Completed
Enrollment 379
Est. completion date May 14, 2019
Est. primary completion date May 14, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - College/university students Exclusion Criteria: - N/A

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindful Self-Compassion
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.

Locations

Country Name City State
Norway University of Bergen Bergen Hordaland

Sponsors (1)

Lead Sponsor Collaborator
University of Bergen

Country where clinical trial is conducted

Norway, 

References & Publications (17)

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

Avalos L, Tylka TL, Wood-Barcalow N. The Body Appreciation Scale: development and psychometric evaluation. Body Image. 2005 Sep;2(3):285-97. Epub 2005 Aug 26. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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.

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.

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. — View Citation

Frost, R.O., Marten, P., Lahart, C., Rosenblate R. The dimensions of perfectionism. Cognitive Therapy and Research, 14 (1990), pp. 449-468.

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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.

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. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change in perfectionism 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 Change in body image 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
Secondary Change in depressive tendencies 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
Secondary Change in anxiety 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
Secondary Change in self-compassion 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
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