TrichotillomaniaNCT04559750
Internet CBT for Trichotillomania and Skin Picking Disorder
A study testing Internet delivered behavior therapy (I-BT) in people with Trichotillomania and Excoriation (Skin-Picking) Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trichotillomania, Excoriation (Skin-Picking) Disorder
- What is being tested?
- Internet delivered behavior therapy (I-BT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 5 Oct 2020to 23 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Region Stockholm
Stockholm
About this study
Official title: 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.
- Being tested
- Internet delivered behavior therapy (I-BT)
- Medical subject headings
- Trichotillomania, Excoriation Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet delivered behavior therapy (I-BT)Behavioural
10 weeks of I-BT
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered behavior therapy (I-BT | Experimental | 10 weeks of (I-BT) delivered via the Internet. Receives: Behavioral: Internet delivered behavior therapy (I-BT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Massachusetts General Hospital Hairpulling Scale
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.
Measured: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
The Skin Picking Scale - Revised
A 6-item self-report measure of skin picking disorder severity.
Measured: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Secondary outcomes (16)
Montgomery Åsberg Depression Rating Scale Self Rate
Total scores on the scale range from 0 to 54 with higher scores indicating a worse outcome (more severe depressive symptoms).
Measured: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Sheehan Disability Scale
Total scores on the scale range from 0 to 30 with higher scores indicating a worse outcome (higher degree of disability).
Measured: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Acceptance and Action Questionnaire
Total scores on the scale range from 10 to 70 with higher scores indicating a worse outcome (decreased levels of accpetance).
Measured: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Acceptance and Action Questionnaire for Trichotillomania
Total scores on the scale range from 9 to 63 with higher scores indicating a worse outcome (decreased levels of accpetance).
Measured: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
The Skin Picking Impact Scale
Total scores on the scale range from 0 to 50 with higher scores indicating a worse outcome (higher impact of skin picking).
Measured: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
The NIMH Trichotillomania Symptom Severity Scale
Total scores on the scale range from 0 to 30 with higher scores indicating a worse outcome (higher symptom severity).
Measured: Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
The NIMH Trichotillomania a Impairment Scale
Total scores on the scale range from 0 to 10 with higher scores indicating a worse outcome (higher impairment).
Measured: Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
Patient Health Questionnaire 9.
Total scores on the scale range from 0 to 27 with higher scores indicating a worse outcome (more severe depressive symptoms).
Measured: Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
EuroQol 5D, (EQ5D).
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.
Measured: Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
Client Satisfaction Questionnaire-8.
Total scores range from 8 to 32, with higher scores indicating greater satisfaction with a health care service.
Measured: Scores at post-treatment (week 10).
Treatment credibility scale.
The total score ranges from 1 to 10, with a higher score indicating a higher trust in the treatment.
Measured: Scores at mid-treatment (week 5) and post-treatment (week 10).
Working Alliance Inventory - Short Form.
The scale ranges from 12 to 84, with higher scores indicating a stronger working alliance.
Measured: Scores at mid-treatment (week 5) and post-treatment (week 10).
Clinical global impression - severity scale.
Independent clinicians rate the severity of illness from "normal" (1) to "extremely ill" (7).
Measured: Change from baseline (week 0) to post-treatment (week 10)] and 12-month follow-up.
Clinical global impression - improvement scale.
Independent clinicians rate the improvement from "very much improved" (1), to "very much worse".
Measured: Ratings at post-treatment (week 10) and at 12-month follow-up.
Global Assessment of functioning scale
Independent clinicians rate the symptoms and their effect on functioning from 1 to 100.
Measured: Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
Negative events questionnaire (NEQ).
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).
Measured: Ratings at post-treatment (week 10).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start5 Oct 2020
- Primary completion7 Dec 2020
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrichotillomaniaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Volen Ivanov, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559750
- Sponsor's protocol ID
- 2019-06325
- Other IDs
- 2019
- Status last verified
- Aug 2022
- First submitted
- 8 Sep 2020
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Delivered Cognitive Behavior Therapy for Trichotillomania and Skin Picking Disorder
- ClinicalTrials.gov ID
- NCT04559750
- Acronym / sponsor ID
- 2019-06325
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered behavior therapy (I-BT | Experimental | Behavioral: Internet delivered behavior therapy (I-BT)10 weeks of (I-BT) delivered via the Internet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet delivered behavior therapy (I-BT)10 weeks of I-BT | Behavioural | Internet-delivered behavior therapy (I-BT |
Primary outcome
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.
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.
16 secondary outcomes
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.
Sheehan Disability Scale
Time frame: 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.
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.
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.
The NIMH Trichotillomania Symptom Severity Scale
Time frame: 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.
Patient Health Questionnaire 9.
Time frame: 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.
Client Satisfaction Questionnaire-8.
Time frame: Scores at post-treatment (week 10).
Treatment credibility scale.
Time frame: 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).
Clinical global impression - severity scale.
Time frame: 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.
Global Assessment of functioning scale
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Trichotillomania
Recruiting
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
Mindfulness Skills, Psychosocial Education
Recruiting
Neural Mechanisms of Response Inhibition Training for OCRD
Obsessive-Compulsive Disorder, Tricholemmoma
Active, not recruitingPhase 2/3
Behavioral Treatment and Memantine in Body Focused Repetitive Behaviors
Skin-Picking, Trichotillomania (Hair-Pulling Disorder)
Not yet recruitingPhase 2
Semaglutide (Wegovy) Treatment for Trichotillomania
Trichotillomania (Hair-Pulling Disorder), Trichotillomania
Recruiting
Technology Assisted Treatment for Trichotillomania
Trichotillomania
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet delivered behavior therapy (I-BT) in people with Trichotillomania and Excoriation (Skin-Picking) Disorder, 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 6 inclusion and 7 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 7 Sep 2022. 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?
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.). 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?
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 7 Sep 2022.