Internet CBT for Trichotillomania and Skin Picking Disorder

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: Completed
• Conditions: Trichotillomania; Excoriation (Skin-Picking) Disorder
• Intervention / Treatment: Behavioral: Internet delivered behavior therapy (I-BT)

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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).

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Actual): December 7, 2020
• Study Completion (Actual): December 23, 2021

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Trichotillomania
• Other Study ID 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