Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-02-17 @ 7:04 PM
Study NCT ID:
NCT01673035
Status:
COMPLETED
Last Update Posted:
2016-03-03
First Post:
2012-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet Treatment for Health Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006998', 'term': 'Hypochondriasis'}], 'ancestors': [{'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-02', 'studyFirstSubmitDate': '2012-08-22', 'studyFirstSubmitQcDate': '2012-08-22', 'lastUpdatePostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'psychological mediators', 'timeFrame': 'week 1, 2, 3, 4, 5, 6, 7, 8, 8, 10, 11, 12', 'description': 'Assessment of whether these mediators will precede change in outcome during the treatment'}], 'primaryOutcomes': [{'measure': 'Health Anxiety Inventory (HAI)', 'timeFrame': 'baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up', 'description': 'Change in HAI at post-treatment and follow-ups compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Illness attitude scale (IAS)', 'timeFrame': 'baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up', 'description': 'Change in IAS at post-treatment and follow-ups compared to baseline'}, {'measure': 'Whiteley Index (WI)', 'timeFrame': 'baseline, post-treatment (12 weeks) 6-month follow-up, 12 month follow-up', 'description': 'Change in WI at post-treatment and follow-ups compared to baseline'}, {'measure': 'Montgomery Åsberg depression rating scale-self report (MADRS-S)', 'timeFrame': 'baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up', 'description': 'Change in MADRS-S at post-treatment and follow-ups compared to baseline.'}, {'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': 'baseline, post-treatment (12 weeks ), 6-month week follow-up, 12-month follow-up', 'description': 'Change in BAI at post-treatment and follow-ups compared to baseline.'}, {'measure': 'Anxiety Sensitivity Index (ASI)', 'timeFrame': 'baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up', 'description': 'Change in ASI at post-treatment and follow-ups compared to baseline'}, {'measure': 'Insomnia severity index (ISI)', 'timeFrame': 'baseline, post-treatment (12 weeks) 6-month follow-up, 12-month follow-up', 'description': 'Change in ISI at post-treatment and follow-ups compared to baseline'}, {'measure': 'Sheehan disability scale (SDS)', 'timeFrame': 'baseline, post-treatment (12) 6-month follow-up, 12-month follow-up', 'description': 'Change in SDS at post-treatment and follow-ups compared to baseline'}, {'measure': 'Trimbos and institute of medical technology assessment cost questionnaire (TIC-P)', 'timeFrame': 'baseline, post-treatment (12 weeks ), 6-month follow-up, 12-month follow-up', 'description': 'Change in TIC-P at post-treatment and follow-ups compared to baseline'}, {'measure': 'Euroqol-5D (EQ-5D)', 'timeFrame': 'baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up', 'description': 'Change in EQ-5D)I at post-treatment and follow-ups compared to baseline'}, {'measure': 'Obsessive compulsive inventory revised (OCI-R)', 'timeFrame': 'baseline', 'description': 'Only for assessing the sample on this symptom domain at pre-treatment.'}, {'measure': 'Yale-brown obsessive compulsive scale (YBOCS)', 'timeFrame': 'Baseline, post-treatment (variable depending on disorder), weeks 26, weeks 52', 'description': 'only for assessing the sample on this domain at pre-treatment'}, {'measure': 'AUDIT (alcohol use)', 'timeFrame': 'baseline, 12 weeks, 6 month follow-up, 12 month follow-up', 'description': 'Change in AUDIT at post-treatment and follow-ups compared to baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypochondriasis']}, 'referencesModule': {'references': [{'pmid': '27113231', 'type': 'DERIVED', 'citation': 'Hedman E, Andersson E, Ljotsson B, Axelsson E, Lekander M. Cost effectiveness of internet-based cognitive behaviour therapy and behavioural stress management for severe health anxiety. BMJ Open. 2016 Apr 25;6(4):e009327. doi: 10.1136/bmjopen-2015-009327.'}, {'pmid': '25104835', 'type': 'DERIVED', 'citation': 'Hedman E, Axelsson E, Gorling A, Ritzman C, Ronnheden M, El Alaoui S, Andersson E, Lekander M, Ljotsson B. Internet-delivered exposure-based cognitive-behavioural therapy and behavioural stress management for severe health anxiety: randomised controlled trial. Br J Psychiatry. 2014 Oct;205(4):307-14. doi: 10.1192/bjp.bp.113.140913. Epub 2014 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'Background\n\nSevere health anxiety, hypochondriasis according to DSM-IV, is common and associated with functional disability. Cognitive behavior therapy (CBT) and behavioral stress management (BSM) have been showed to be effective in the treatment of severe health anxiety. The mechanisms of the treatments are however poorly understood. In addition, effective psychological treatments are accessible to only a few. One prior RCT has shown that internet-based CBT could be effective in comparison to waiting list controls. More studies on internet-based CBT is essential to establish evidence. In addition, few studies with sufficient power have investigated the effect of CBT in comparison to other active treatments.\n\nAim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to behavioral stress management (n=110) for adult participants with severe health anxiety. BSM is considered a comparison treatment for two reasons: it has been shown to be effective and it lacks exposure and response prevention, which is suggested to be an important mechanism in CBT.\n\nParticipants in both treatments are expected to be significantly improved on measures of health anxiety. Participants receiving CBT are expected to be significantly more improved compared to participants receiving BSM.', 'detailedDescription': 'Background\n\nSevere health anxiety, hypochondriasis according to DSM-IV, is common and associated with functional disability. Cognitive behavior therapy (CBT) and behavioral stress management (BSM) have been showed to be effective in the treatment of severe health anxiety. The mechanisms of the treatments are however poorly understood. In addition, effective psychological treatments are accessible to only a few. One prior RCT has shown that internet-based CBT could be effective in comparison to waiting list controls. More studies on internet-based CBT is essential to establish evidence. In addition, few studies with sufficient power have investigated the effect of CBT in comparison to other active treatments.\n\nAim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to behavioral stress management (n=110) for adult participants with severe health anxiety. BSM is considered a comparison treatment for two reasons: it has been shown to be effective and it lacks exposure and response prevention, which is suggested to be an important mechanism in CBT.\n\nThe investigators expect participants in both treatments to be significantly improved on measures of health anxiety. Participants receiving CBT are expected to be significantly more improved compared to participants receiving BSM.\n\nDesign:\n\nRandomized controlled trial. Participants are randomized in a 1:1 ratio.\n\nAssessments:\n\nThe primary outcome measure is the Health Anxiety Inventory (HAI). Assessments with HAI are conducted at baseline, post-treatment, 3- and 12 month follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A primary diagnosis of severe health anxiety (hypochondriasis) according to DSM-IV\n* At least 18 years old\n* Able to read and write in Swedish\n\nExclusion Criteria:\n\n* Other primary axis-I disorder\n* Ongoing substance abuse or addiction\n* current or previous episode of psychosis or bipolar disorder\n* higher score than 30 on the Montgomery åsberg depression rating scale-self report\n* higher than 3 on the suicide item of the MADRS-S\n* non-stable antidepressant medication during last 2 months if on this kind of medication\n* ongoing concurrent psychological treatment for severe health anxiety\n* having received previous high quality CBT during the recent 3 years\n* ongoing serious somatic disorder'}, 'identificationModule': {'nctId': 'NCT01673035', 'acronym': 'HA-X', 'briefTitle': 'Internet Treatment for Health Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Cognitive Behavior Therapy vs. Behavioral Stress Management for Severe Health Anxiety: a Randomized Controlled Trial of Two Internet-based Treatments', 'orgStudyIdInfo': {'id': 'HA-X'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'internet-based CBT', 'description': 'Cognitive behavior therapy delivered via the internet: 12 weeks, therapist-guided', 'interventionNames': ['Behavioral: CBT, exposure and response prevention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'internet-based BSM', 'description': 'behavioral stress management delivered via the internet: 12 weeks, therapist-guided', 'interventionNames': ['Behavioral: BSM, stress management and applied relaxation']}], 'interventions': [{'name': 'CBT, exposure and response prevention', 'type': 'BEHAVIORAL', 'description': 'This intervention entails different exercises aimed exposure to health anxiety stimuli.', 'armGroupLabels': ['internet-based CBT']}, {'name': 'BSM, stress management and applied relaxation', 'type': 'BEHAVIORAL', 'description': 'BSM, this intervention comprises structured exercises aimed at reducing stress and controlling the anxiety response. One main component is applied relaxation.', 'armGroupLabels': ['internet-based BSM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17177', 'city': 'Stockholm', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Erik Hedman, phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Erik Hedman', 'investigatorAffiliation': 'Karolinska Institutet'}}}}