Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2026-01-05 @ 7:01 AM
Study NCT ID:
NCT03496350
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2018-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-delivered Cognitive Behavioural Therapy in Arabic for Anxiety and Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants get randomly assigned to either treatment or wait-list control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-19', 'studyFirstSubmitDate': '2018-03-29', 'studyFirstSubmitQcDate': '2018-04-05', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'pre-treatment ,week 3, week 6, week 8 and 12 months post-treatment', 'description': 'The PHQ-9 is a nine-item self-report questionnaire that measures symptoms of depression. It is scored from 0-27 with a higher score reflecting more severe symptoms.'}, {'measure': 'Change in Generalised Anxiety Disorder-7-item scale, (GAD-7)', 'timeFrame': 'pre-treatment ,week 3, week 6, week 8 and 12 months post-treatment', 'description': 'The GAD-7 is a seven-item self-report questionnaire that measures symptoms of anxiety. It is scored from 0-21 with a higher score reflecting more severe symptoms.'}], 'secondaryOutcomes': [{'measure': 'Alcohol Use Disorder Identification Test (AUDIT)', 'timeFrame': 'pre-treatment, week 8', 'description': 'Measures alcohol consumption, drinking behaviors, and alcohol-related problems. It is scored from 0-40 with higher scores reflecting more alcohol consumption, drinking behaviors, and alcohol-related problems.'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'pre-treatment, week 8', 'description': 'Self-reported symptoms of insomnia. It is scored from 0-28 with higher scores reflecting more symptoms of insomnia.'}, {'measure': 'Impact of Events Scale - Revised (IES-R)', 'timeFrame': 'pre-treatment, week 8', 'description': 'Self-reported symptoms of post-traumatic stress. It is scored from 0-88 where higher scores reflect more symptoms.'}, {'measure': 'Perceived Stress Scale (PSS)', 'timeFrame': 'pre-treatment, week 8', 'description': 'Self-reported stress-related symptoms. It is scored from 0-56 with higher scores reflecting more symtoms of perceived stress.'}, {'measure': '"Brunnsviken Brief Quality of Life Scale" (BBQ)', 'timeFrame': 'pre-treatment, week 8', 'description': 'Self-reported quality of life. The scale is scored from 0-96 with a higher score reflecting higher self-reported quality of life.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety', 'Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of a culturally adapted internet-administrated cognitive behaviour therapy (ICBT) in Arabic for anxiety and depression', 'detailedDescription': 'The study will compare the effect of the intervention against a wait-list control. The intervention tested is based on cognitive behavior therapy delivered over the internet via a secure treatment platform. Participants in the study are recruited from the general public via social media. The intervention is in Arabic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be above 18 years of age\n* Have symptoms of anxiety and/or depression\n* Be able to read and write in Arabic\n* Have access to computer or smartphone\n\nExclusion Criteria:\n\n* Suicidal ideation\n* Alcohol addiction\n* Other major primary psychiatric disorder\n* Ongoing psychological treatment\n* Recent (during last 4 weeks) change in psychiatric medication'}, 'identificationModule': {'nctId': 'NCT03496350', 'briefTitle': 'Internet-delivered Cognitive Behavioural Therapy in Arabic for Anxiety and Depression', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Culturally Adapted Transdiagnostic Internet-delivered Cognitive Behavioural Therapy in Arabic for Anxiety and Depression', 'orgStudyIdInfo': {'id': 'SAHA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet CBT', 'description': 'Internet-based cognitive behavioural therapy in Arabic with therapeutic guidance through email.', 'interventionNames': ['Behavioral: Internet-delivered CBT']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list', 'description': 'Wait-list control'}], 'interventions': [{'name': 'Internet-delivered CBT', 'type': 'BEHAVIORAL', 'description': 'Culturally adapted transdiagnostic internet-delivered CBT in Arabic', 'armGroupLabels': ['Internet CBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '581 83', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Linköping University', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Gerhard Andersson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linkoeping University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gerhard Andersson', 'investigatorAffiliation': 'Linkoeping University'}}}}