Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-02-20 @ 7:06 PM
Study NCT ID:
NCT02638792
Status:
COMPLETED
Last Update Posted:
2017-11-28
First Post:
2015-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 311}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-26', 'studyFirstSubmitDate': '2015-12-19', 'studyFirstSubmitQcDate': '2015-12-19', 'lastUpdatePostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Treatment credibility scale', 'timeFrame': 'Week 2', 'description': 'Investigate if both conditions have equal credibility in order to rule out placebo'}, {'measure': 'Working alliance scale', 'timeFrame': 'Week 5', 'description': 'Investigate if both conditions have equal working alliance in order to rule out non-specific factors'}], 'primaryOutcomes': [{'measure': 'Penn State Worry Questionnaire (PSWQ)', 'timeFrame': 'week 0, week 10 (weekly measurements), at 4 months follow up, 12 months follow up.', 'description': 'Change in worry from baseline to Week 10 and at 4- and 12 months after treatment has ended.'}], 'secondaryOutcomes': [{'measure': 'Montgomery Åsberg Depression Rating Scale (MADRS-S)', 'timeFrame': 'Week 0, Week 10, 4 and 12 months follow-up', 'description': 'Change in depression from baseline to Week 10 and at 4- and 12 months after treatment has ended.'}, {'measure': 'Euroqol, EQ-5D', 'timeFrame': 'Week 0, Week 10, 4 and 12 months follow-up', 'description': 'Change in general health from baseline to Week 10 and at 4- and 12 months after treatment has ended'}, {'measure': 'Cognitive Avoidance Questionnaire (CAQ)', 'timeFrame': 'Week 0, Week 10, at 4 and 12 months follow up and weekly during treatment', 'description': 'Change in cognitive avoidance from baseline to Week 10, at 4- and 12 after treatment has ended, and weekly during treatment'}, {'measure': 'Intolerance of uncertainty scale', 'timeFrame': 'Week 0, Week 10, at 4 and 12 months follow-up, and weekly during treatment', 'description': 'Change in thought control efforts from baseline to Week 10, at 4- and 12 months after treatment has ended, and weekly during treatment'}, {'measure': 'Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)', 'timeFrame': 'Week 0, Week 10, 4 and 12 months follow-up', 'description': 'Change in economic costs from baseline to Week 10 and at 4- and 12 months after treatment has ended'}, {'measure': 'Brunnsviken Quality of Life Questionnaire (BBQ)', 'timeFrame': 'Week 0, Week 10, 4 and 12 months follow-up', 'description': 'Change in self-perceived quality of life from baseline to week 10 and at 4 and 12 months after treatment has ended'}, {'measure': 'Thought supression subscale of the Cognitive Avoidance Questionnaire (CAQ)', 'timeFrame': 'Week 0 - Week 10 (weekly measurements)', 'description': 'Weekly change in thought supression from baseline to Week 10'}, {'measure': 'The self-regulation subscale of the Multidimensional Assessment of Interoceptive Awareness', 'timeFrame': 'Week 0 - Week 10 (weekly measurements)', 'description': 'Weekly change in self-regulation from baseline to Week 10'}, {'measure': 'Patient Health Questionnaire-2', 'timeFrame': 'Week 0 - Week 10 (weekly measurements)', 'description': 'Weekly change in depressive symptom from baseline to Week 10'}, {'measure': 'Adverse Events', 'timeFrame': 'Week 3, week 8, week 10, 4 and 12 months follow-up', 'description': 'Number of adverse events from baseline to Week 10 and at 4 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Excessive Worry']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine if an internet-based exposure therapy is more effective in reducing excessive worry amongst patients who suffer from this problem than is internet-based stress management training.', 'detailedDescription': 'Trial Objectives: Primary objective is to investigate whether an Internet-based exposure therapy can reduce the degree of excessive worry to a significantly greater extent than Internet-based stress-management training. The secondary objective is to a) investigate the cost-effectiveness of this treatment b) to study if any variables could moderate/mediate the treatment outcome, c) and to investigate the importance of sudden gains for the treatment outcome\n\nTrial Design: Randomized controlled trial with an active control and a waitlist control, who also will recieve treatment after the first group has finished.\n\nDuration: Ten weeks\n\nPrimary Endpoint:\n\nDifference in worry symptoms between the treatment groups at week 10. Long term follow-up is also investigated (baseline to 4-months after treatment completion and baseline to 12-months after treatment completion).\n\nEfficacy Parameters: Penn State Worry Questionnaire (PSWQ)\n\nSafety Parameters: Adverse Events is assessed via the internet.\n\nDescription of Trial Subjects: Patients \\> 18 years old with a PSWQ score more than 56 points\n\nNumber of Subjects: 300'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients\n* ≥ 18 years\n* Situated in Sweden\n* Informed consent\n* PSWQ score more than 56 points\n\nExclusion Criteria:\n\n* Substance dependence during the last six months\n* Post traumatic stress disorder, bipolar disorder or psychosis\n* Symptoms better explained by axis 2 diagnosis (e.g. autism or borderline personality disorder)\n* MADRS-S score above 25 points\n* Psychotropic medication changes within two months prior to treatment that could affect target symptoms.\n* Received exposure based CBT for pathological worry the last 2 years.'}, 'identificationModule': {'nctId': 'NCT02638792', 'briefTitle': 'Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'REPN 2015/1698-31/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet-based exposure therapy', 'description': 'The internet-based exposure therapy (I-ET) group receives a ten-week Internet-based CBT treatment, which is an extended version of the self-help book "Sluta älta och grubbla med kognitiv beteendeterapi" (How to quit worrying and ruminating with Cognitive behavior therapy) by licensed psychologist Olle Wadström (2007). The main focus of the book is to expose to the frightening word/image and refrain from using neutralizing thoughts. This is supposed to lead to the extinction of upsetting words/images.', 'interventionNames': ['Behavioral: Internet-based exposure therapy (I-ET)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Internet-based stress management therapy', 'description': 'The I-SMT group receives a ten-week Internet-based CBT treatment focused on stress and how to manage stressful situations. This protocol is based on current evidence based recommendations for worry and has shown to be effective when delivered via the internet for irritable bowel syndrome and hypochondric worries.', 'interventionNames': ['Behavioral: Internet-based stress management therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist', 'description': 'When the active treatment groups have finished treatment (W11), the WL group will be able to start active treatment and be assessed at post-treatment, and 4, 12 months later using the same questionnaires as the treatment group. The participants will be able to choose which treatment they receive i.e. no randomization.'}], 'interventions': [{'name': 'Internet-based exposure therapy (I-ET)', 'type': 'BEHAVIORAL', 'description': 'The internet-based exposure therapy (I-ET) group receives a ten-week Internet-based CBT treatment, which is an extended version of the self-help book "Sluta älta och grubbla med kognitiv beteendeterapi" (How to quit worrying and ruminating with Cognitive behavior therapy) by licensed psychologist Olle Wadström (2007). The main focus of the book is to expose to the frightening word/image and refrain from using neutralizing thoughts. This is supposed to lead to the extinction of upsetting words/images.', 'armGroupLabels': ['Internet-based exposure therapy']}, {'name': 'Internet-based stress management therapy', 'type': 'BEHAVIORAL', 'description': 'The I-SMT group receives a ten-week Internet-based CBT treatment focused on stress and how to manage stressful situations. This protocol is based on current evidence based recommendations for worry and has shown to be effective when delivered via the internet for irritable bowel syndrome and hypochondric worries.', 'armGroupLabels': ['Internet-based stress management therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17177', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Intitutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Erik M Andersson, PhD, Psych.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Lic. psychologist', 'investigatorFullName': 'Erik Andersson', 'investigatorAffiliation': 'Karolinska Institutet'}}}}