Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-01-02 @ 10:49 AM
Study NCT ID:
NCT05820568
Status:
COMPLETED
Last Update Posted:
2023-10-02
First Post:
2022-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet Delivered Cognitive Behavior Therapy Based on Intolerance of Uncertainty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pilot'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-29', 'studyFirstSubmitDate': '2022-12-08', 'studyFirstSubmitQcDate': '2023-04-17', 'lastUpdatePostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rate of treatment dropout', 'timeFrame': '10 weeks after treatment start', 'description': 'Patient terminates treatment ahead of schedule'}, {'measure': 'Adherence', 'timeFrame': '10 weeks after treatment start', 'description': 'Number of modules completed'}], 'primaryOutcomes': [{'measure': 'Generalized Anxiety Disorder 7-item (GAD7)', 'timeFrame': '10 weeks after treatment start', 'description': 'Symptoms of generalized anxiety disorder measured by the self report measure GAD7. Scores range from 0-21 with higher scores indicating more generalized anxiety'}], 'secondaryOutcomes': [{'measure': 'Treatment credibility', 'timeFrame': '2 weeks into treatment', 'description': 'A version of the credibility expectancy questionnaire used at the Internet Psychiatry Clinic in Sweden. Scores range from 5 to 50 with higher scores indicating more credibility.'}, {'measure': 'Satisfaction with treatment', 'timeFrame': '10 weeks after treatment start', 'description': 'Client Satisfaction Questionnaire 8 item version (CSQ8). Scores range from 8 to 32; scores of 8-13 indicate poor satisfaction, 14-19 fair satisfaction, 20-25 good satisfaction, and 26-32 excellent satisfaction.'}, {'measure': 'Symptoms of depression including suicidal ideation', 'timeFrame': '10 weeks after treatment start', 'description': 'Measured with the Montgomery Åsberg Depression Rating Scale- Self report (MADRS-S). Scores range from 0-54 with higher scores indicating more depression'}, {'measure': 'Intolerance of uncertainty', 'timeFrame': '10 weeks after treatment start', 'description': 'Measured with the Intolerance of Uncertainty Scale short version (IUS-12). Scores range from 12-60 with higher scores indicating more intolerance of uncertainty.'}, {'measure': 'Excessive worry', 'timeFrame': '10 weeks after treatment start', 'description': 'Measured with the Penn State Worry Questionnaore (PSWQ). Scores range from 16-80 points with more points indicating more worry'}, {'measure': 'Symptoms of depression', 'timeFrame': '10 weeks after treatment start', 'description': 'Measured with the Patient Health Questionnaire-9 item self report measure (PHQ9).The scale range is 0-27 with higher scores indication more depression.'}, {'measure': 'WHO Disability Assessment Schedule (WHODAS 2.0) self report (12 items)', 'timeFrame': '10 weeks after treatment start', 'description': 'A health and disability metric developed by WHO. Scores range from 0-100% and represent the level of disability with 100% being complete disability to function in everyday life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['internet delivered treatment', 'digital mental health services', 'psychiatry', 'cognitive behavior therapy', 'intolerance of uncertainty'], 'conditions': ['Generalized Anxiety Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical is to pilot test an internet delivered cognitive behavior therapy (ICBT) based on intolerance of uncertainty (one of several existing specific cognitive models for how worry works) in treating generalised anxiety disorder (GAD). The main aims is to:\n\n* Test the preliminary effect of the intervention in lowering symptoms of GAD as measured by the self report scale GAD-7\n* Test procedures for recruitment, assessment, treatment and follow up\n* Test the acceptability of the intervention as measured by the Client Satisfaction questionnaire-8, dropout and adverse events\n\nParticipants will apply for treatment in an online system, be assessed via video by a licensed clinical psychologist and then receive a 10 week long ICBT intervention based on the intolerance of uncertainty model. This is a pilot study for an upcoming randomized controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or more.\n* Diagnosis of GAD based on clinical assessment.\n* At least 10 points on GAD-7 at screening.\n* Proficient in written Swedish.\n* Access to internet enabled device and Swedish BankID for authentication\n* Able to make sufficient time for the 10 week long treatment\n* Consents to study\n\nExclusion Criteria:\n\n* In need of treatment for other psychiatric diagnosis as priority (eg depression, psychosis) or high risk of suicide based on clinical assessment\n* Ongoing risk use of alcohol or drugs\n* Ongoing serious somatic of social disease/problem that is deemed to be to much of a hindrance for the completion of the treatment'}, 'identificationModule': {'nctId': 'NCT05820568', 'acronym': 'ORIGAMI', 'briefTitle': 'Internet Delivered Cognitive Behavior Therapy Based on Intolerance of Uncertainty', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Effects and Mechanisms of Change of Two Different Treatments Targeting Worry in Generalised Anxiety Disorder: Study 1 - IU Pilot', 'orgStudyIdInfo': {'id': '2022-02380-01-Pilot'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Patients receiving ICBT-IU', 'interventionNames': ['Behavioral: ICBT-IU']}], 'interventions': [{'name': 'ICBT-IU', 'type': 'BEHAVIORAL', 'description': 'Internet delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder based on the Intolerance of uncertainty model of worry', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14135', 'city': 'Stockholm', 'state': 'Huddinge', 'country': 'Sweden', 'facility': 'Internet Psychiatry Clinic, Psychiatry Southwest, 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': 'Erik Forsell', 'investigatorAffiliation': 'Karolinska Institutet'}}}}