NCT03453437

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
379

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

February 3, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2019

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

January 16, 2018

Last Update Submit

August 16, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in body image

    Baseline (two for control group), one week prior to intervention, one week after last session, 6 months after intervention

  • Change in depressive tendencies

    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

    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

    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

Study Arms (2)

Control group

NO INTERVENTION

Receiving no intervention (control groups will be offered the intervention after the experimental group has completed the course)

Active group

EXPERIMENTAL

Receiving Mindful Self-Compassion intervention

Behavioral: Mindful Self-Compassion

Interventions

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.

Active group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • College/university students

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bergen

Bergen, Hordaland, 5020, Norway

Location

Related Publications (18)

  • 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.

    PMID: 18089195BACKGROUND
  • 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.

    PMID: 21584907BACKGROUND
  • 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.

    PMID: 28850726BACKGROUND
  • Frost, R.O., Marten, P., Lahart, C., Rosenblate R. The dimensions of perfectionism. Cognitive Therapy and Research, 14 (1990), pp. 449-468.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 11578668BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 19308994BACKGROUND
  • 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.

    PMID: 24886015BACKGROUND
  • 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.

    PMID: 24764525BACKGROUND
  • 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.

    PMID: 27038782BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 27061929BACKGROUND
  • 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.

    PMID: 25064287BACKGROUND
  • 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.

    PMID: 24114894BACKGROUND
  • 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

    BACKGROUND
  • 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.

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Per-Einar Binder, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2018

First Posted

March 5, 2018

Study Start

February 3, 2018

Primary Completion

May 14, 2019

Study Completion

May 14, 2019

Last Updated

August 17, 2021

Record last verified: 2021-08

Locations