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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
379

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Norway
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Bergen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Depression

Clinical Trials on Mindful Self-Compassion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings