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Completed

NCT Number: NCT04559750

Internet CBT 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.

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Key information

Conditions

Trichotillomania Anxiety Disorders Behavior Behavioral Symptoms Disruptive, Impulse Control, and Conduct Disorders Excoriation (Skin-Picking) Disorder Excoriation Disorder Mental Disorders Obsessive-Compulsive Disorder Self-Injurious Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet delivered behavior therapy (I-BT)

Behavioral

10 weeks of I-BT

Primary outcomes

  1. 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.

  2. 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

  1. Montgomery Åsberg Depression Rating Scale Self Rate

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

  16. Negative events questionnaire (NEQ).

    Time frame: Ratings at post-treatment (week 10).

    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).

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Internet Delivered Cognitive Behavior Therapy for Trichotillomania and Skin Picking Disorder

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Sep 23, 2020
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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