NCT04559750

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

October 5, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2021

Completed
Last Updated

September 7, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

September 8, 2020

Last Update Submit

August 31, 2022

Conditions

TrichotillomaniaExcoriation (Skin-Picking) Disorder

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (16)

  • 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.

  • Sheehan Disability Scale

    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.

  • Acceptance and Action Questionnaire for Trichotillomania

    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.

  • +11 more secondary outcomes

Study Arms (1)

Internet-delivered behavior therapy (I-BT

EXPERIMENTAL

10 weeks of (I-BT) delivered via the Internet.

Behavioral: Internet delivered behavior therapy (I-BT)

Interventions

Internet delivered behavior therapy (I-BT)BEHAVIORAL

10 weeks of I-BT

Internet-delivered behavior therapy (I-BT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Stockholm, Sweden

Location

MeSH Terms

Conditions

TrichotillomaniaExcoriation Disorder

Condition Hierarchy (Ancestors)

Obsessive-Compulsive DisorderAnxiety DisordersMental DisordersDisruptive, Impulse Control, and Conduct DisordersSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2020

First Posted

September 23, 2020

Study Start

October 5, 2020

Primary Completion

December 7, 2020

Study Completion

December 23, 2021

Last Updated

September 7, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)