Internet CBT for Trichotillomania and Skin Picking Disorder

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT04559750
Collaborator
Region Stockholm (Other)
25
1
1
14.6
1.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Internet delivered behavior therapy (I-BT)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Internet Delivered Cognitive Behavior Therapy for Trichotillomania and Skin Picking Disorder
Actual Study Start Date :
Oct 5, 2020
Actual Primary Completion Date :
Dec 7, 2020
Actual Study Completion Date :
Dec 23, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The Massachusetts General Hospital Hairpulling Scale [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.

  2. The Skin Picking Scale - Revised [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 Outcome Measures

  1. 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.]

    Total scores on the scale range from 0 to 54 with higher scores indicating a worse outcome (more severe depressive symptoms).

  2. Sheehan Disability Scale [Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.]

    Total scores on the scale range from 0 to 30 with higher scores indicating a worse outcome (higher degree of disability).

  3. Acceptance and Action Questionnaire [Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.]

    Total scores on the scale range from 10 to 70 with higher scores indicating a worse outcome (decreased levels of accpetance).

  4. Acceptance and Action Questionnaire for Trichotillomania [Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.]

    Total scores on the scale range from 9 to 63 with higher scores indicating a worse outcome (decreased levels of accpetance).

  5. The Skin Picking Impact Scale [Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.]

    Total scores on the scale range from 0 to 50 with higher scores indicating a worse outcome (higher impact of skin picking).

  6. The NIMH Trichotillomania Symptom Severity Scale [Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.]

    Total scores on the scale range from 0 to 30 with higher scores indicating a worse outcome (higher symptom severity).

  7. The NIMH Trichotillomania a Impairment Scale [Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.]

    Total scores on the scale range from 0 to 10 with higher scores indicating a worse outcome (higher impairment).

  8. Patient Health Questionnaire 9. [Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.]

    Total scores on the scale range from 0 to 27 with higher scores indicating a worse outcome (more severe depressive symptoms).

  9. EuroQol 5D, (EQ5D). [Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.]

    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.

  10. Client Satisfaction Questionnaire-8. [Scores at post-treatment (week 10).]

    Total scores range from 8 to 32, with higher scores indicating greater satisfaction with a health care service.

  11. Treatment credibility scale. [Scores at mid-treatment (week 5) and post-treatment (week 10).]

    The total score ranges from 1 to 10, with a higher score indicating a higher trust in the treatment.

  12. Working Alliance Inventory - Short Form. [Scores at mid-treatment (week 5) and post-treatment (week 10).]

    The scale ranges from 12 to 84, with higher scores indicating a stronger working alliance.

  13. Clinical global impression - severity scale. [Change from baseline (week 0) to post-treatment (week 10)] and 12-month follow-up.]

    Independent clinicians rate the severity of illness from "normal" (1) to "extremely ill" (7).

  14. Clinical global impression - improvement scale. [Ratings at post-treatment (week 10) and at 12-month follow-up.]

    Independent clinicians rate the improvement from "very much improved" (1), to "very much worse".

  15. Global Assessment of functioning scale [Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.]

    Independent clinicians rate the symptoms and their effect on functioning from 1 to 100.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Region Stockholm Stockholm Sweden

Sponsors and Collaborators

  • Karolinska Institutet
  • Region Stockholm

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Volen Ivanov, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT04559750
Other Study ID Numbers:
  • 2019-06325
First Posted:
Sep 23, 2020
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2022