Clinical trial NCT04559750: Internet CBT for Trichotillomania and Skin Picking Disorder
Official title: Internet Delivered Cognitive Behavior Therapy for Trichotillomania and Skin Picking Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trichotillomania
Excoriation (Skin-Picking) Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2020-09-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The Massachusetts General Hospital Hairpulling Scale
timeFrame: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
measure: The Skin Picking Scale - Revised
timeFrame: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
Secondary outcomes:
measure: Montgomery Åsberg Depression Rating Scale Self Rate
timeFrame: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
measure: Sheehan Disability Scale
timeFrame: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
measure: Acceptance and Action Questionnaire
timeFrame: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
measure: Acceptance and Action Questionnaire for Trichotillomania
timeFrame: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
measure: The Skin Picking Impact Scale
timeFrame: Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.
measure: The NIMH Trichotillomania Symptom Severity Scale
timeFrame: Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
measure: The NIMH Trichotillomania a Impairment Scale
timeFrame: Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
measure: Patient Health Questionnaire 9.
timeFrame: Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
measure: EuroQol 5D, (EQ5D).
timeFrame: Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
measure: Client Satisfaction Questionnaire-8.
timeFrame: Scores at post-treatment (week 10).
measure: Treatment credibility scale.
timeFrame: Scores at mid-treatment (week 5) and post-treatment (week 10).
measure: Working Alliance Inventory - Short Form.
timeFrame: Scores at mid-treatment (week 5) and post-treatment (week 10).
measure: Clinical global impression - severity scale.
timeFrame: Change from baseline (week 0) to post-treatment (week 10)] and 12-month follow-up.
measure: Clinical global impression - improvement scale.
timeFrame: Ratings at post-treatment (week 10) and at 12-month follow-up.
measure: Global Assessment of functioning scale
timeFrame: Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.
measure: Negative events questionnaire (NEQ).
timeFrame: Ratings at post-treatment (week 10).
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Region Stockholm
Study officials:
References: