Internet CBT for Trichotillomania and Skin Picking Disorder

Trichotillomania Clinical Trial

Official title:

Internet Delivered Cognitive Behavior Therapy for Trichotillomania and Skin Picking Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04559750
• Other study ID #: 2019-06325
• Status: Completed
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: December 23, 2021

Study information

• Verified date: August 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 23, 2021
• Est. primary completion date: December 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Excoriation (Skin-Picking) Disorder
• Trichotillomania

Intervention

Behavioral:
• Internet delivered behavior therapy (I-BT)
10 weeks of I-BT

Locations

Country	Name	City	State
Sweden	Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Region Stockholm	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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).