Internet CBT for Trichotillomania and Skin Picking Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Internet Delivered Cognitive Behavior Therapy for Trichotillomania and Skin Picking Disorder

Conditions
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Trichotillomania, Excoriation (Skin-Picking) Disorder

Intervention / Treatment
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* Behavioral: Internet delivered behavior therapy (I-BT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-delivered behavior therapy (I-BT<br>10 weeks of (I-BT) delivered via the Internet. | Behavioral: Internet delivered behavior therapy (I-BT)<br>* 10 weeks of I-BT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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). | Ratings at post-treatment (week 10). |