Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-30 @ 12:15 AM
Study NCT ID:
NCT04559750
Status:
COMPLETED
Last Update Posted:
2022-09-07
First Post:
2020-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet CBT for Trichotillomania and Skin Picking Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014256', 'term': 'Trichotillomania'}, {'id': 'D000096705', 'term': 'Excoriation Disorder'}], 'ancestors': [{'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007174', 'term': 'Disruptive, Impulse Control, and Conduct Disorders'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-31', 'studyFirstSubmitDate': '2020-09-08', 'studyFirstSubmitQcDate': '2020-09-16', 'lastUpdatePostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', '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.'}, {'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.', 'description': 'A 6-item self-report measure of skin picking disorder severity.'}], 'secondaryOutcomes': [{'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.', 'description': 'Total scores on the scale range from 0 to 54 with higher scores indicating a worse outcome (more severe depressive symptoms).'}, {'measure': 'Sheehan Disability Scale', 'timeFrame': 'Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.', 'description': 'Total scores on the scale range from 0 to 30 with higher scores indicating a worse outcome (higher degree of disability).'}, {'measure': 'Acceptance and Action Questionnaire', 'timeFrame': 'Change from baseline (week 0) to post-treatment (week 10), 1-, 3-, 6- and 12-month follow-up.', 'description': 'Total scores on the scale range from 10 to 70 with higher scores indicating a worse outcome (decreased levels of accpetance).'}, {'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.', 'description': 'Total scores on the scale range from 9 to 63 with higher scores indicating a worse outcome (decreased levels of accpetance).'}, {'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.', 'description': 'Total scores on the scale range from 0 to 50 with higher scores indicating a worse outcome (higher impact of skin picking).'}, {'measure': 'The NIMH Trichotillomania Symptom Severity Scale', 'timeFrame': 'Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.', 'description': 'Total scores on the scale range from 0 to 30 with higher scores indicating a worse outcome (higher symptom severity).'}, {'measure': 'The NIMH Trichotillomania a Impairment Scale', 'timeFrame': 'Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.', 'description': 'Total scores on the scale range from 0 to 10 with higher scores indicating a worse outcome (higher impairment).'}, {'measure': 'Patient Health Questionnaire 9.', 'timeFrame': 'Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.', 'description': 'Total scores on the scale range from 0 to 27 with higher scores indicating a worse outcome (more severe depressive symptoms).'}, {'measure': 'EuroQol 5D, (EQ5D).', 'timeFrame': 'Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.', '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.'}, {'measure': 'Client Satisfaction Questionnaire-8.', 'timeFrame': 'Scores at post-treatment (week 10).', 'description': 'Total scores range from 8 to 32, with higher scores indicating greater satisfaction with a health care service.'}, {'measure': 'Treatment credibility scale.', 'timeFrame': 'Scores at mid-treatment (week 5) and post-treatment (week 10).', 'description': 'The total score ranges from 1 to 10, with a higher score indicating a higher trust in the treatment.'}, {'measure': 'Working Alliance Inventory - Short Form.', 'timeFrame': 'Scores at mid-treatment (week 5) and post-treatment (week 10).', 'description': 'The scale ranges from 12 to 84, with higher scores indicating a stronger working alliance.'}, {'measure': 'Clinical global impression - severity scale.', 'timeFrame': 'Change from baseline (week 0) to post-treatment (week 10)] and 12-month follow-up.', 'description': 'Independent clinicians rate the severity of illness from "normal" (1) to "extremely ill" (7).'}, {'measure': 'Clinical global impression - improvement scale.', 'timeFrame': 'Ratings at post-treatment (week 10) and at 12-month follow-up.', 'description': 'Independent clinicians rate the improvement from "very much improved" (1), to "very much worse".'}, {'measure': 'Global Assessment of functioning scale', 'timeFrame': 'Change from baseline (week 0) to post-treatment (week 10) and 12-month follow-up.', 'description': 'Independent clinicians rate the symptoms and their effect on functioning from 1 to 100.'}, {'measure': 'Negative events questionnaire (NEQ).', 'timeFrame': 'Ratings at post-treatment (week 10).', '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Trichotillomania', 'Excoriation (Skin-Picking) Disorder']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary diagnosis of trichotillomania and/or skin picking disorder according to DSM-5\n* Living in Sweden with a Swedish personal identification number\n* Able to participate in study assessment in Swedish and understand Swedish text\n* Have regular access to a computer with Internet access and skills to use Internet\n* Signed informed consent\n* Outpatient\n\nExclusion Criteria:\n\n* Psychotropic medication changes that can affect symptoms of trichotillomania or skin picking disorder within 2 months prior to treatment\n* Other ongoing psychological treatments that could affect symptoms of trichotillomania or skin picking disorder\n* Completed CBT for trichotillomania or skin picking disorder within the last 24 months\n* Ongoing substance dependence or misuse\n* Lifetime bipolar disorder or psychosis\n* Suicidal ideation (a score of 5 points or higher on item 9 on the self-reported Montgomery-Åsberg depression rating scale\n* Psychiatric comorbidity that could severely jeopardize treatment participation'}, 'identificationModule': {'nctId': 'NCT04559750', 'briefTitle': 'Internet CBT for Trichotillomania and Skin Picking Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Internet Delivered Cognitive Behavior Therapy for Trichotillomania and Skin Picking Disorder', 'orgStudyIdInfo': {'id': '2019-06325'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet-delivered behavior therapy (I-BT', 'description': '10 weeks of (I-BT) delivered via the Internet.', 'interventionNames': ['Behavioral: Internet delivered behavior therapy (I-BT)']}], 'interventions': [{'name': 'Internet delivered behavior therapy (I-BT)', 'type': 'BEHAVIORAL', 'description': '10 weeks of I-BT', 'armGroupLabels': ['Internet-delivered behavior therapy (I-BT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Psykiatri Nordväst, Stockholms Läns Sjukvårdsområde (SLSO), Region Stockholm', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Stockholm', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Volen Ivanov', 'investigatorAffiliation': 'Karolinska Institutet'}}}}