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Clinical Trials/NCT04559750
NCT04559750
Completed
Not Applicable

Internet Delivered Cognitive Behavior Therapy for Trichotillomania and Skin Picking Disorder

Karolinska Institutet1 site in 1 country25 target enrollmentOctober 5, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trichotillomania
Sponsor
Karolinska Institutet
Enrollment
25
Locations
1
Primary Endpoint
The Massachusetts General Hospital Hairpulling Scale
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 5, 2020
End Date
December 23, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Volen Ivanov

Principal Investigator

Karolinska Institutet

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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.)
  • Acceptance and Action Questionnaire(Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.)
  • The Skin Picking Impact Scale(Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.)
  • The NIMH Trichotillomania Symptom Severity Scale(Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.)
  • The NIMH Trichotillomania a Impairment Scale(Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.)
  • Treatment credibility scale.(Scores at mid-treatment (week 5) and post-treatment (week 10).)
  • Clinical global impression - severity scale.(Change from baseline (week 0) to post-treatment (week 10)] and 12-month follow-up.)
  • Negative events questionnaire (NEQ).(Ratings at post-treatment (week 10).)
  • Sheehan Disability Scale(Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.)
  • EuroQol 5D, (EQ5D).(Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.)
  • Working Alliance Inventory - Short Form.(Scores at mid-treatment (week 5) and post-treatment (week 10).)
  • Global Assessment of functioning scale(Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.)
  • Acceptance and Action Questionnaire for Trichotillomania(Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.)
  • Patient Health Questionnaire 9.(Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.)
  • Client Satisfaction Questionnaire-8.(Scores at post-treatment (week 10).)
  • Clinical global impression - improvement scale.(Ratings at post-treatment (week 10) and at 12-month follow-up.)

Study Sites (1)

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