AzTrials
AzTrials

PerfectionismNCT04459260

Treating Perfectionism Using Internet-Based Cognitive Behavior Therapy

A study testing Cognitive Behavior Therapy and Unified Protocol in people with Perfectionism and Anxiety, run by Karolinska Institutet at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Perfectionism, Anxiety, Depression
What is being tested?
Cognitive Behavior Therapy and Unified Protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
1 siteSweden
Study dates
24 Aug 2020to 1 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Uppsala University

    Uppsala

Other trials in Sweden

About this study

Official title: Treating Perfectionism Using Internet-Based Cognitive Behavior Therapy: A Randomized Controlled Trial Comparing Cognitive Behavior Therapy to Unified Protocol

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.

Being tested
Cognitive Behavior Therapy, Unified Protocol
Keywords
Perfectionism, Cognitive Behavior Therapy, Unified Protocol, Internet-based, Randomized controlled trial
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavior TherapyBehavioural

    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.

  • Unified ProtocolBehavioural

    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.

Study groups in NCT04459260
Study groupRoleWhat they receive
Cognitive Behavior TherapyExperimentalAn 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.
Receives: Behavioral: Cognitive Behavior Therapy
Unified ProtocolActive comparatorAn 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.
Receives: Behavioral: Unified Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: One month

  2. 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).

    Measured: One month

Secondary outcomes (10)
  1. Patient Health Questionnaire - 9 Items (PHQ-9)

    The nine-item PHQ-9 assesses the degree of depression and is scored on a four-point Likert-scale 0-3 ("Not at all" to "Nearly every day"). The PHQ-9 is often used as a screening tool for depressive symptoms, has been validated against other self-report measures and clinical interviews of depression, and has an excellent internal consistency (Kroenke et al., 2001).

    Measured: Two weeks

  2. Generalized Anxiety Disorder - 7 Items (GAD-7)

    The seven-item Generalized Anxiety Disorder (GAD-7) determines the level of anxiety and is scored on a four-point Likert-scale 0-3 ("Not at all" to "Nearly every day"). The GAD-7 is often used for screening for symptoms of anxiety and worry, corresponds well with other similar self-report measures, and has exhibited excellent internal consistency (Spitzer, Kroenke, Williams, \& Lowe, 2006).

    Measured: Two weeks

  3. Brunnsviken Brief Quality of Life (BBQ)

    The 12-item Brunnsviken Brief Quality of Life (BBQ) explores the quality of life in six areas, e.g., leisure and learning, and level of importance, e.g., "my leisure time is important to me", which are then multiplied with each other. The BBQ is scored on a four-point scale 1-4 ("Strongly disagree" to "Strongly agree"), with a range in scores of 0-96. The BBQ demonstrates good convergent and discriminant validity, good classification ability, and has an adequate internal consistency (Lindner et al., 2016).

    Measured: One month

  4. Self-Compassion Scale - Short Form (SCS-SF)

    The 12-item Self-Compassion Scale - Short Form (SCS-SF) tests the degree of self-compassion and is scored on a five-point scale 1-5 ("Almost never" to "Almost all of the time"). The SCS-SF has been shown to correlate with self-report measures of psychiatric symptoms, and has a good internal consistency (Raes, Pommier, Neff, \& Van Gucht, 2011).

    Measured: One month

  5. Pure Procrastination Scale (PPS)

    The 12-item Pure Procrastination Scale (PPS) determines the level of procrastination and is scored on a five-point Likert-scale 1-5 ("Seldom, or do not agree" to "Very often, or totally agree). The PPS has been shown to have good convergent and discriminant validity, and internal consistency (Rozental, Forsell, et al., 2014; Steel, 2010).

    Measured: One month

  6. Perceived Stress Scale (PSS)

    The 14-item Perceived Stress Scale (PSS) evaluates the subjective experience of general stress in various situations and is scored on a five-point Likert-scale 0-4 ("Never" to "Very often"), with seven items being scored in reverse (items 4-7, 9-10, and 13). The PSS has been shown to have adequate internal consistency as well as good convergent and discriminant validity (Cohen, Kamarck, \& Mermelstein, 1983).

    Measured: One month

  7. Negative Effects Questionnaire (NEQ)

    Negative Effects Questionnaire (NEQ) will be used to probe for unwanted and adverse events that might arise during treatment, which is scored on a five-point Likert-scale 0-4 ("Not at all" to "Extreme"), and classifies the incidents as caused by the treatment or other circumstances. The NEQ has demonstrated excellent internal consistency and is mainly used to descriptively determine the occurrence and nature of possible negative effects (Rozental, Kottorp, Boettcher, Andersson, \& Carlbring, 2016).

    Measured: One month

  8. Credibility/Expectancy Questionnaire

    The perceived integrity of treatment will be explored using the five-item Credibility/Expectancy Questionnaire (Borkovec \& Nau, 1972), which is scored on a 10-point Likert-scale 0-10 (e.g., "Not at all logical" to " Very logical"). It has exhibited good internal consistency and test-retest reliability, with the factor expectancy being correlated with outcomes of treatment (Devilly \& Borkovec, 2000).

    Measured: Two weeks

  9. Domains

    The effects of treatment will be explored using subjective ratings of its impact on different domains. This will entail eight aspects of life that each participant rates on a 10-point Likert-scale 0-10 with regard to how perfectionism is affecting them negatively ("Not at all" to "Very much"): interests/leisure, work/studies, friendships/social life, community engagement/spirituality, family life/parenting, rest/sleep, love/intimate relationships, and physical activity/diet.

    Measured: One month

  10. Goal attainment

    The effects of treatment will be explored using participants own statements and definitions of their goals of treatment, and to what extent they have lived up to them, rated on a 10-point Likert-scale 0-10.

    Measured: One month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start24 Aug 2020
  3. Primary completion1 Nov 2020
  4. Study completion1 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04459260
Sponsor's protocol ID
UU2020-0001
Status last verified
Mar 2024
First submitted
1 Jul 2020
Last updated
15 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Masked and anonymised data will be able to retrieve upon request.

Publications

  • 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.

    PubMed 38483057

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavior Therapy and Unified Protocol in people with Perfectionism and Anxiety, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Perfectionism Questionnaire (CPQ) (time frame: One month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04459260, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in