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Internet CBT for Trichotillomania and Skin Picking Disorder

Primary Purpose

Trichotillomania, Excoriation (Skin-Picking) Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet delivered behavior therapy (I-BT)
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trichotillomania

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Internet-delivered behavior therapy (I-BT

Arm Description

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

Outcomes

Primary Outcome Measures

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.
The Skin Picking Scale - Revised
A 6-item self-report measure of skin picking disorder severity.

Secondary Outcome Measures

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).
Sheehan Disability Scale
Total scores on the scale range from 0 to 30 with higher scores indicating a worse outcome (higher degree of disability).
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).
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).
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).
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).
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).
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).
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.
Client Satisfaction Questionnaire-8.
Total scores range from 8 to 32, with higher scores indicating greater satisfaction with a health care service.
Treatment credibility scale.
The total score ranges from 1 to 10, with a higher score indicating a higher trust in the treatment.
Working Alliance Inventory - Short Form.
The scale ranges from 12 to 84, with higher scores indicating a stronger working alliance.
Clinical global impression - severity scale.
Independent clinicians rate the severity of illness from "normal" (1) to "extremely ill" (7).
Clinical global impression - improvement scale.
Independent clinicians rate the improvement from "very much improved" (1), to "very much worse".
Global Assessment of functioning scale
Independent clinicians rate the symptoms and their effect on functioning from 1 to 100.
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).

Full Information

First Posted
September 8, 2020
Last Updated
August 31, 2022
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT04559750
Brief Title
Internet CBT for Trichotillomania and Skin Picking Disorder
Official Title
Internet Delivered Cognitive Behavior Therapy for Trichotillomania and Skin Picking Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
December 7, 2020 (Actual)
Study Completion Date
December 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trichotillomania, Excoriation (Skin-Picking) Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-delivered behavior therapy (I-BT
Arm Type
Experimental
Arm Description
10 weeks of (I-BT) delivered via the Internet.
Intervention Type
Behavioral
Intervention Name(s)
Internet delivered behavior therapy (I-BT)
Intervention Description
10 weeks of I-BT
Primary Outcome Measure Information:
Title
The Massachusetts General Hospital Hairpulling Scale
Description
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.
Time Frame
Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Title
The Skin Picking Scale - Revised
Description
A 6-item self-report measure of skin picking disorder severity.
Time Frame
Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Secondary Outcome Measure Information:
Title
Montgomery Åsberg Depression Rating Scale Self Rate
Description
Total scores on the scale range from 0 to 54 with higher scores indicating a worse outcome (more severe depressive symptoms).
Time Frame
Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Title
Sheehan Disability Scale
Description
Total scores on the scale range from 0 to 30 with higher scores indicating a worse outcome (higher degree of disability).
Time Frame
Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Title
Acceptance and Action Questionnaire
Description
Total scores on the scale range from 10 to 70 with higher scores indicating a worse outcome (decreased levels of accpetance).
Time Frame
Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Title
Acceptance and Action Questionnaire for Trichotillomania
Description
Total scores on the scale range from 9 to 63 with higher scores indicating a worse outcome (decreased levels of accpetance).
Time Frame
Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Title
The Skin Picking Impact Scale
Description
Total scores on the scale range from 0 to 50 with higher scores indicating a worse outcome (higher impact of skin picking).
Time Frame
Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Title
The NIMH Trichotillomania Symptom Severity Scale
Description
Total scores on the scale range from 0 to 30 with higher scores indicating a worse outcome (higher symptom severity).
Time Frame
Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
Title
The NIMH Trichotillomania a Impairment Scale
Description
Total scores on the scale range from 0 to 10 with higher scores indicating a worse outcome (higher impairment).
Time Frame
Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
Title
Patient Health Questionnaire 9.
Description
Total scores on the scale range from 0 to 27 with higher scores indicating a worse outcome (more severe depressive symptoms).
Time Frame
Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
Title
EuroQol 5D, (EQ5D).
Description
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.
Time Frame
Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
Title
Client Satisfaction Questionnaire-8.
Description
Total scores range from 8 to 32, with higher scores indicating greater satisfaction with a health care service.
Time Frame
Scores at post-treatment (week 10).
Title
Treatment credibility scale.
Description
The total score ranges from 1 to 10, with a higher score indicating a higher trust in the treatment.
Time Frame
Scores at mid-treatment (week 5) and post-treatment (week 10).
Title
Working Alliance Inventory - Short Form.
Description
The scale ranges from 12 to 84, with higher scores indicating a stronger working alliance.
Time Frame
Scores at mid-treatment (week 5) and post-treatment (week 10).
Title
Clinical global impression - severity scale.
Description
Independent clinicians rate the severity of illness from "normal" (1) to "extremely ill" (7).
Time Frame
Change from baseline (week 0) to post-treatment (week 10)] and 12-month follow-up.
Title
Clinical global impression - improvement scale.
Description
Independent clinicians rate the improvement from "very much improved" (1), to "very much worse".
Time Frame
Ratings at post-treatment (week 10) and at 12-month follow-up.
Title
Global Assessment of functioning scale
Description
Independent clinicians rate the symptoms and their effect on functioning from 1 to 100.
Time Frame
Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
Title
Negative events questionnaire (NEQ).
Description
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).
Time Frame
Ratings at post-treatment (week 10).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Region Stockholm
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Internet CBT for Trichotillomania and Skin Picking Disorder

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