Internet CBT for Trichotillomania and Skin Picking Disorder

Not Applicable

Completed

• Conditions: Excoriation (Skin-Picking) Disorder; Trichotillomania
• Interventions: Behavioral: Internet delivered behavior therapy (I-BT)

• Registration Number: NCT04559750
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-23
• Study Start: 2020-10-05
• Primary Completion: 2020-12-07
• Study Completion: 2021-12-23
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-31
• Last Update Posted: 2022-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Internet-delivered behavior therapy (I-BT	Internet delivered behavior therapy (I-BT)	10 weeks of (I-BT) delivered via the Internet.

Primary Outcome Measures

Name	Time	Method
The Massachusetts General Hospital Hairpulling Scale	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	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.

Secondary Outcome Measures

Name	Time	Method
Montgomery Åsberg Depression Rating Scale Self Rate	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).
Acceptance and Action Questionnaire	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).
The Skin Picking Impact Scale	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).
The NIMH Trichotillomania Symptom Severity Scale	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).
The NIMH Trichotillomania a Impairment Scale	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).
Treatment credibility scale.	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.
Clinical global impression - severity scale.	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).
Negative events questionnaire (NEQ).	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).
Sheehan Disability Scale	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).
EuroQol 5D, (EQ5D).	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.
Working Alliance Inventory - Short Form.	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.
Global Assessment of functioning scale	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.
Acceptance and Action Questionnaire for Trichotillomania	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).
Patient Health Questionnaire 9.	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).
Client Satisfaction Questionnaire-8.	Scores at post-treatment (week 10).	Total scores range from 8 to 32, with higher scores indicating greater satisfaction with a health care service.
Clinical global impression - improvement scale.	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".

Trial Locations

Locations (1)

Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Region Stockholm; 🇸🇪 Stockholm, Sweden