NCT04459260

Brief Summary

Perfectionism is characterized by setting high standards and striving for achievement, sometimes at the expense of social relationships and wellbeing. Despite sometimes being viewed as a positive feature by others, people with perfectionism tend to be overly concerned about their performance and how they are being perceived by people around them. This tends to create inflexible standards, cognitive biases, and performance-related behaviors that maintain a belief that self-worth is linked to accomplishments. Cognitive behavior therapy has been shown to be a viable treatment for perfectionism, both in terms of reducing levels of perfectionism and improving psychiatric symptoms. Furthermore, a number of recent studies indicate that it can be successfully delivered via the Internet, both with regular support and guidance on demand from a therapist. In the present study protocol, a clinical trial for perfectionism is described and outlined. In total, 128 participants will be recruited and randomized to either a treatment that has already been demonstrated to have many benefits, Internet-based Cognitive Behavior Therapy for perfectionism (iCBT-P), or an active comparison condition, Internet-based Unified Protocol (iUP), targeting the emotions underlying depression and anxiety disorders. The results will be investigated with regard to self-reported outcomes of perfectionism, psychiatric symptoms, self-compassion, and quality of life, at post-treatment and at six- and 12-month follow-up. Both iCBT-P and iUP are expected to have positive effects, but the difference between conditions and adherence to respective treatment are currently unknown and will be explored. The clinical trial is believed to lead to a better understanding of how perfectionism can be treated, with the aim of providing efficacious treatments in an accessible format via the Internet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

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

July 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 24, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

July 1, 2020

Last Update Submit

March 14, 2024

Conditions

Keywords

PerfectionismCognitive Behavior TherapyUnified ProtocolInternet-basedRandomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • Clinical Perfectionism Questionnaire (CPQ)

    The CPQ is a self-report measure determining the level of perfectionism and consists of 12 items that are scored on a four-point Likert-scale 1-4 ("Not at all" to "All of the time"), with two items that are in reverse (items 2 and 8), and employing a time-frame of one month to increase its clinical usefulness. The CPQ was translated to Swedish in a previous clinical trial, demonstrating good convergent and discriminant validity when compared to self-report measures of perfectionism and psychiatric symptoms, as well as adequate internal consistency and test-retest reliability (McMahan et al., submitted).

    One month

  • Frost Multidimensional Perfectionism Scale (FMPS)

    The FMPS is self-report measure determining the level of perfectionism and is scored on a five-point Likert-scale 1-5 ("Strongly disagree" to "Strongly agree"), with a total of 35 items that cover the six separate subscales Concern over Mistakes, Personal Standards, Doubts about Action, Parental Expectations, Parental Criticism, and Organization. However, only the two first are usually of interest in clinical trials as the other subscales are considered less related to the two higher-order dimensions of perfectionism (Limburg et al., 2017). The subscales of the FMPS has adequate to excellent internal consistencies and exhibits convergent and discriminant validity when compared to self-report measures of perfectionism and psychiatric symptoms (Purdon, Antony, \& Swinson, 1999). The FMPS was originally translated to Swedish by Lundh, Broman, Hetta, and Saboonchi (1994).

    One month

Secondary Outcomes (10)

  • Patient Health Questionnaire - 9 Items (PHQ-9)

    Two weeks

  • Generalized Anxiety Disorder - 7 Items (GAD-7)

    Two weeks

  • Brunnsviken Brief Quality of Life (BBQ)

    One month

  • Self-Compassion Scale - Short Form (SCS-SF)

    One month

  • Pure Procrastination Scale (PPS)

    One month

  • +5 more secondary outcomes

Study Arms (2)

Cognitive Behavior Therapy

EXPERIMENTAL

An eight-week Internet-based self-guided treatment, delivered with guidance on demand from therapists in training. The treatment is based on cognitive behavior therapy and includes both cognitive interventions, e.g., cognitive restructuring and behavioral experiments, and behavioral interventions, behavioral activation. The treatment was manualized by Egan et al. (2016) and has been tested in several clinical trials, both via the Internet and face-to-face.

Behavioral: Cognitive Behavior Therapy

Unified Protocol

ACTIVE COMPARATOR

An eight-week Internet-based self-guided treatment, delivered with guidance on demand from therapists in training. The treatment is based on a transdiagnostic approach derived from cognitive behavior therapy called Unified Protocol, focusing on the shared emotional aspects underlying depression and anxiety disorders. The treatment was manualized by Ellard et al. (2010) and has been tested in several clinical trials, but so far not over the Internet.

Behavioral: Unified Protocol

Interventions

A standardized evidence-based treatment manual based on cognitive behavior therapy, developed specifically for targeting perfectionism (Egan et al., 2016). Includes the following components: 1) providing psychoeducation about perfectionism and creating an individualized conceptualization 2) broadening the domains for self-evaluation 3) testing out beliefs and predictions, and 4) addressing personal standards and self-criticism. Week 1: Understanding your perfectionism. Week 2: Your own model, values, and motivation. Week 3: Surveys and experiments. Week 4: Dealing with perfectionistic behaviors. Week 5: New ways of thinking. Week 6: Self-criticism and self-compassion. Week 7: Self-worth. Week 8: Maintain and continue positive change.

Cognitive Behavior Therapy

A standardized evidence-based treatment manual based on cognitive behavior therapy, developed to target the shared emotional factors in depression and anxiety disorders (Ellard et al., 2010). Fundamental to this approach is to register and become more aware of the emotions, cognitions, and physical sensations that occur in difficult situation, and to try out more adaptive ways of coping in these instances. Week 1: Emotional symptoms. Week 2: Understanding your emotions. Week 3: Emotional awareness. Week 4: Thoughts. Week 5: Behaviors. Week 6: Emotional exposure. Week 7: Continued emotional exposure. Week 8: Planning ahead.

Unified Protocol

Eligibility Criteria

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

You may qualify if:

  • At least 18 years
  • Adequate reading and writing levels in Swedish
  • A computer, smartphone, or tablet with Internet access
  • Elevated levels of perfectionism, as determined by a score of \>29 on the subscale Concerns over Mistakes on the Frost Multidimensional Perfectionism Scale

You may not qualify if:

  • Diagnoses warranting immediate care, e.g., anorexia nervosa, substance abuse, bipolar disorder, psychosis, and schizophrenia
  • Severe depression, as determined by a score of \>15 points on the Patient Health Questionnaire - 9 Items
  • Suicidality, as determined by \>2 points on the item on suicidal ideation on the Patient Health Questionnaire - 9 Items

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University

Uppsala, Sweden

Location

Related Publications (1)

  • Rozental A, Shafran R, Johansson F, Forsstrom D, Jovicic F, Gelberg O, Molin K, Carlbring P, Andersson G, Buhrman M. Treating perfectionism via the Internet: a randomized controlled trial comparing cognitive behavior therapy to unified protocol. Cogn Behav Ther. 2024 May;53(3):324-350. doi: 10.1080/16506073.2024.2327339. Epub 2024 Mar 14.

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Monica Buhrman, PhD

    Monica.Buhrman@psyk.uu.se

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 7, 2020

Study Start

August 24, 2020

Primary Completion

November 1, 2020

Study Completion

November 1, 2021

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Masked and anonymised data will be able to retrieve upon request.

Locations