Internet CBT for Trichotillomania and Skin Picking Disorder

August 31, 2022 updated by: Volen Ivanov, Karolinska Institutet

Internet Delivered Cognitive Behavior Therapy for Trichotillomania and Skin Picking Disorder

The primary aim of the study is to test the feasibility, safety and efficacy of a manual based, Internet-delivered, behavior therapy (I-BT) for trichotillomania and skin picking disorder.

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.

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.
25

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

  • Sweden
      • Stockholm, Sweden
        • Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Region Stockholm

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary diagnosis of trichotillomania and/or skin picking disorder according to DSM-5
  • Living in Sweden with a Swedish personal identification number
  • Able to participate in study assessment in Swedish and understand Swedish text
  • Have regular access to a computer with Internet access and skills to use Internet
  • Signed informed consent
  • Outpatient

Exclusion Criteria:

  • Psychotropic medication changes that can affect symptoms of trichotillomania or skin picking disorder within 2 months prior to treatment
  • Other ongoing psychological treatments that could affect symptoms of trichotillomania or skin picking disorder
  • Completed CBT for trichotillomania or skin picking disorder within the last 24 months
  • Ongoing substance dependence or misuse
  • Lifetime bipolar disorder or psychosis
  • Suicidal ideation (a score of 5 points or higher on item 9 on the self-reported Montgomery-Åsberg depression rating scale
  • Psychiatric comorbidity that could severely jeopardize treatment participation

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: N/A
  • Interventional Model: Single Group 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.
Experimental: Internet-delivered behavior therapy (I-BT
10 weeks of (I-BT) delivered via the Internet.
Behavioral: Internet delivered behavior therapy (I-BT)
10 weeks of I-BT

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
The Massachusetts General Hospital Hairpulling Scale
Time Frame: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
A self-report instrument for assessing repetitive hairpulling. The scale consists of seven items, rated for severity from 0 to 4 which assess urges to pull, actual pulling, perceived control, and associated distress.
Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
The Skin Picking Scale - Revised
Time Frame: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
A 6-item self-report measure of skin picking disorder severity.
Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.

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
Montgomery Åsberg Depression Rating Scale Self Rate
Time Frame: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Total scores on the scale range from 0 to 54 with higher scores indicating a worse outcome (more severe depressive symptoms).
Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Sheehan Disability Scale
Time Frame: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Total scores on the scale range from 0 to 30 with higher scores indicating a worse outcome (higher degree of disability).
Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Acceptance and Action Questionnaire
Time Frame: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Total scores on the scale range from 10 to 70 with higher scores indicating a worse outcome (decreased levels of accpetance).
Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Acceptance and Action Questionnaire for Trichotillomania
Time Frame: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Total scores on the scale range from 9 to 63 with higher scores indicating a worse outcome (decreased levels of accpetance).
Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
The Skin Picking Impact Scale
Time Frame: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Total scores on the scale range from 0 to 50 with higher scores indicating a worse outcome (higher impact of skin picking).
Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
The NIMH Trichotillomania Symptom Severity Scale
Time Frame: Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
Total scores on the scale range from 0 to 30 with higher scores indicating a worse outcome (higher symptom severity).
Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
The NIMH Trichotillomania a Impairment Scale
Time Frame: Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
Total scores on the scale range from 0 to 10 with higher scores indicating a worse outcome (higher impairment).
Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
Patient Health Questionnaire 9.
Time Frame: Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
Total scores on the scale range from 0 to 27 with higher scores indicating a worse outcome (more severe depressive symptoms).
Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
EuroQol 5D, (EQ5D).
Time Frame: Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
The responses of the individual are weighted and calculated from 1 (full health) to 0 (death). The measure also includes a self-rated health scale, which ranges from 0 to 100, with higher scores indicating better self-rated health.
Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
Client Satisfaction Questionnaire-8.
Time Frame: Scores at post-treatment (week 10).
Total scores range from 8 to 32, with higher scores indicating greater satisfaction with a health care service.
Scores at post-treatment (week 10).
Treatment credibility scale.
Time Frame: Scores at mid-treatment (week 5) and post-treatment (week 10).
The total score ranges from 1 to 10, with a higher score indicating a higher trust in the treatment.
Scores at mid-treatment (week 5) and post-treatment (week 10).
Working Alliance Inventory - Short Form.
Time Frame: Scores at mid-treatment (week 5) and post-treatment (week 10).
The scale ranges from 12 to 84, with higher scores indicating a stronger working alliance.
Scores at mid-treatment (week 5) and post-treatment (week 10).
Clinical global impression - severity scale.
Time Frame: Change from baseline (week 0) to post-treatment (week 10)] and 12-month follow-up.
Independent clinicians rate the severity of illness from "normal" (1) to "extremely ill" (7).
Change from baseline (week 0) to post-treatment (week 10)] and 12-month follow-up.
Clinical global impression - improvement scale.
Time Frame: Ratings at post-treatment (week 10) and at 12-month follow-up.
Independent clinicians rate the improvement from "very much improved" (1), to "very much worse".
Ratings at post-treatment (week 10) and at 12-month follow-up.
Global Assessment of functioning scale
Time Frame: Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
Independent clinicians rate the symptoms and their effect on functioning from 1 to 100.
Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
Negative events questionnaire (NEQ).
Time Frame: Ratings at post-treatment (week 10).
The scale reports frequencies of negative events perceived by the participant as probably being caused by treatment and the negative impact of these events on a scale from 0 (not at all) to 4 (extreme).
Ratings at post-treatment (week 10).

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.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Region Stockholm

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.
October 5, 2020

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.
December 7, 2020

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.
December 23, 2021

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).
September 8, 2020

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.
September 16, 2020

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.
September 23, 2020

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.
September 7, 2022

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 31, 2022

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, 2022

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.
  • 2019-06325

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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