- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04459260
Treating Perfectionism Using Internet-Based Cognitive Behavior Therapy
Treating Perfectionism Using Internet-Based Cognitive Behavior Therapy: A Randomized Controlled Trial Comparing Cognitive Behavior Therapy to Unified Protocol
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Uppsala, Sweden
- Uppsala University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive Behavior Therapy
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.
|
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. |
|
Active Comparator: Unified Protocol
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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Perfectionism Questionnaire (CPQ)
Time Frame: One month
|
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)
Time Frame: One month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire - 9 Items (PHQ-9)
Time Frame: Two weeks
|
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).
|
Two weeks
|
|
Generalized Anxiety Disorder - 7 Items (GAD-7)
Time Frame: Two weeks
|
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).
|
Two weeks
|
|
Brunnsviken Brief Quality of Life (BBQ)
Time Frame: One month
|
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).
|
One month
|
|
Self-Compassion Scale - Short Form (SCS-SF)
Time Frame: One month
|
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).
|
One month
|
|
Pure Procrastination Scale (PPS)
Time Frame: One month
|
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).
|
One month
|
|
Perceived Stress Scale (PSS)
Time Frame: One month
|
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).
|
One month
|
|
Negative Effects Questionnaire (NEQ)
Time Frame: One month
|
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).
|
One month
|
|
Credibility/Expectancy Questionnaire
Time Frame: Two weeks
|
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).
|
Two weeks
|
|
Domains
Time Frame: One month
|
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.
|
One month
|
|
Goal attainment
Time Frame: One month
|
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.
|
One month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Monica Buhrman, PhD, Monica.Buhrman@psyk.uu.se
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UU2020-0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
Massachusetts General HospitalRecruitingDepression | Depression - Major Depressive Disorder | Depression Chronic | Depression in Adults | Depression Disorders | Depression DisorderUnited States
-
University of California, San FranciscoNational Center for Complementary and Integrative Health (NCCIH)Active, not recruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
ProgenaBiomeWithdrawnDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Sorlandet Hospital HFUniversity of Oslo; Karolinska Institutet; Australian Catholic University; Helse...RecruitingAnxiety | Anxiety Depression | Depression Anxiety Disorder | Depression - Major Depressive DisorderNorway
-
Lipocine Inc.CompletedDepression, Postpartum | Postnatal Depression | Peripartum Depression | Depression, Post-Partum | Postpartum Depression (PPD) | Post-Natal DepressionUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Kolby Walker, DO; Brittany KimbleRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryActive, not recruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of CincinnatiNational Center for Complementary and Integrative Health (NCCIH)RecruitingMild DepressionUnited States
-
University of MinnesotaCompletedDepression SymptomsUnited States
Clinical Trials on Cognitive Behavior Therapy
-
Laval UniversityUniversity of California, BerkeleyCompleted
-
Center for Psychological ConsultationCompletedObsessive Compulsive DisorderUnited States
-
Stockholm UniversityKarolinska InstitutetCompleted
-
VA Office of Research and DevelopmentCompleted
-
Baylor College of MedicineSouth Central VA Mental Illness Research, Education & Clinical CenterCompletedDepression | AnxietyUnited States
-
Ohio State University Comprehensive Cancer CenterCompletedMajor Depressive DisorderUnited States
-
University of OsloNot yet recruitingCognitive Behavior Therapy | Depression - Major Depressive Disorder | Psychodynamic TherapyNorway
-
Henry M. Jackson Foundation for the Advancement...National Alliance for Research on Schizophrenia and DepressionCompletedSuicide, AttemptedUnited States
-
Shanghai 10th People's HospitalRecruitingColorectal Cancer | Cognitive Behavior Therapy | Immune FunctionChina
-
Neuropsychiatrischen Zentrums Hamburg-AltonaUniversity of Hamburg-EppendorfRecruiting