Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-02-27 @ 5:45 AM
Study NCT ID:
NCT02735434
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2016-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-delivered Acceptance and Commitment Therapy for Patients With 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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2016-04-01', 'studyFirstSubmitQcDate': '2016-04-11', 'lastUpdatePostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Psychological flexibility measured with the Acceptance and Action Questionnaire-II (AAQ-II)', 'timeFrame': 'At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation'}, {'measure': 'Non-reactivity measured with a subscale of the Five Facet Mindfulness Questionnaire (FFMQ)', 'timeFrame': 'At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation'}, {'measure': 'Illness perception measured with the Brief Illness Perception Questionnaire (B-IPQ)', 'timeFrame': 'At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation'}, {'measure': 'Personality traits measured with the short version of the Big Five Inventory (BFI-10)', 'timeFrame': 'Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)'}, {'measure': 'Working alliance measured with the Working Alliance Inventory, Patient version (WAI-pt)', 'timeFrame': '2 weeks into treatment, and 3 months after randomisation'}, {'measure': 'Treatment credibility and expectancy measured with the credibility/ expectancy questionnaire', 'timeFrame': 'Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)'}, {'measure': 'Childhood history questionnaire', 'timeFrame': 'Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)'}, {'measure': 'Traumatic events in childhood measured with the Childhood traumatic event scale', 'timeFrame': 'Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)'}, {'measure': 'Attachment style measured with the questionnaire: Experiences in close relationships - relationship structures (ECR-RS)', 'timeFrame': 'Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)'}, {'measure': 'Treatment evaluation of negative effects measured with the Inventory for the assessment of negative effects of psychotherapy (INEP)', 'timeFrame': '9 months after randomisation'}, {'measure': 'Attitudes toward seeking professional help', 'timeFrame': 'At baseline (i.e. at self-referral) and at 3 months after randomisation'}, {'measure': 'Self-reported health care use, work performance and work absence measured with Trimbos/ institute of Health Policy and Management (iMTA) questionnaire for Costs associated with Psychiatric Illness (TiC-P)', 'timeFrame': 'At baseline (i.e. at self-referral) and at 9 months after randomisation'}, {'measure': 'Health care expenditures extracted from Danish national registers, and degree of illness related absence from work extracted from the Danish Register of Sickness absence compensation benefits and Social transfer payments database (DREAM).', 'timeFrame': 'At baseline (i.e. at self-referral) and at 9 months after randomisation'}, {'measure': 'Health literacy measured with the Health Literacy Questionnaire (HLQ)', 'timeFrame': 'At baseline (i.e. at self-referral)'}, {'measure': 'Values measured with the Sources of Meaning and Meaning in life questionnaire (SoMe-26)', 'timeFrame': 'At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation'}, {'measure': 'Negative events and effects of psychological treatment', 'timeFrame': 'At 3 months after randomisation'}], 'primaryOutcomes': [{'measure': 'Whiteley-7 index', 'timeFrame': 'At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation', 'description': 'Health anxiety symptoms'}], 'secondaryOutcomes': [{'measure': 'Demographic questions measured with questions from the Danish study for Functional Disorders (DanFund)', 'timeFrame': 'At baseline (i.e. at self-referral)'}, {'measure': 'Diagnosed somatic illnesses measured with questions from the Danish study for Functional Disorders (DanFund)', 'timeFrame': 'At baseline (i.e. at self-referral)'}, {'measure': 'Quality of life measured with the World Health Organisation Well-being Index-Five (WHO-5)', 'timeFrame': 'At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation'}, {'measure': 'Quality of life measured with the visual analogue scale (VAS question) from Youth profile, National Institute of Public Health', 'timeFrame': 'At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation'}, {'measure': 'Stress measured with questions from the survey Youth stress, Danish Health Authority', 'timeFrame': 'At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation'}, {'measure': 'Health anxiety symptoms measured with the Short Health Anxiety Inventory (SHAI)', 'timeFrame': 'At baseline (i.e. at self-referral), and 3 and 9 months after randomisation'}, {'measure': 'Anxiety, depression, obsessive-compulsive and physical symptoms measured with subscales from the Symptom Checklist (SCL-92)', 'timeFrame': 'At baseline (i.e. at self-referral), and 3 and 9 months after randomisation'}, {'measure': 'Somatisation measured with the Bodily Distress Syndrome Checklist (BDS Checklist)', 'timeFrame': 'At baseline (i.e. at self-referral)'}, {'measure': 'General health status and functioning measured with the Short Form 12 Health Survey (SF-12)', 'timeFrame': 'At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline), 3 and 9 months after randomisation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Health anxiety', 'illness anxiety disorder', 'ACT', 'internet'], 'conditions': ['Hypochondriasis']}, 'referencesModule': {'references': [{'pmid': '34997899', 'type': 'DERIVED', 'citation': 'Risor BW, Frydendal DH, Villemoes MK, Nielsen CP, Rask CU, Frostholm L. Cost Effectiveness of Internet-Delivered Acceptance and Commitment Therapy for Patients with Severe Health Anxiety: A Randomised Controlled Trial. Pharmacoecon Open. 2022 Mar;6(2):179-192. doi: 10.1007/s41669-021-00319-x. Epub 2022 Jan 8.'}, {'pmid': '32404226', 'type': 'DERIVED', 'citation': 'Hoffmann D, Rask CU, Hedman-Lagerlof E, Jensen JS, Frostholm L. Efficacy of internet-delivered acceptance and commitment therapy for severe health anxiety: results from a randomized, controlled trial. Psychol Med. 2021 Nov;51(15):2685-2695. doi: 10.1017/S0033291720001312. Epub 2020 May 14.'}, {'pmid': '31496462', 'type': 'DERIVED', 'citation': 'Hoffmann D, Rask CU, Hedman-Lagerlof E, Eilenberg T, Frostholm L. Accuracy of self-referral in health anxiety: comparison of patients self-referring to internet-delivered treatment versus patients clinician-referred to face-to-face treatment. BJPsych Open. 2019 Sep 9;5(5):e80. doi: 10.1192/bjo.2019.54.'}], 'seeAlsoLinks': [{'url': 'http://www.functionaldisorders.dk', 'label': 'Homepage for the Research Clinic for Functional Disorders, Aarhus University Hospital'}]}, 'descriptionModule': {'briefSummary': "Health anxiety is a prevalent, disabling disorder associated with extensive health care expenditures. The lack of easily accessible, evidence-based psychological treatment combined with delayed diagnostic recognition constitute barriers to receiving treatment.\n\nAim\n\n1. To develop an internet-delivered treatment program, based on 'Acceptance and Commitment Therapy' (ACT), for patients with health anxiety.\n2. To test the feasibility and effectiveness of the treatment programme in a randomized, controlled trial, comparing the treatment with an active control condition.\n\nMethods 150 patients aged 18 years and older can self-refer through a web-page to apply for participation. Before inclusion patients will undergo a video-diagnostic interview. Patients are randomly assigned to 12 weeks of either, 1) active treatment: consisting of internet-based ACT (iACT) with 7 therapist-guided modules of self-help text, exercises, patient videos and audio-files, or 2) active control condition: consisting of an internet-based discussion forum (iFORUM) with 7 topics of discussion.\n\nAll patients will complete self-report questionnaires at baseline, before randomization, at 4 and 8 weeks into treatment, after end of treatment, and at 6-month follow-up.", 'detailedDescription': 'Severe health anxiety (illness anxiety disorder) or hypochondriasis, according to the psychiatric classification system ICD-10, is characterized by preoccupation with fear of having a serious illness, which interferes with daily functions and persists despite medical reassurance. Clinical significant health anxiety is prevalent in primary care with 0.8-9.5%, and has a lifetime prevalence of 5.7% in the general population. It is a disabling disorder, associated with extensive use of health care services and occupational disability.\n\nEarlier, health anxiety has been considered a chronic disease with poor treatment outcomes. A recent review found effect of both medicine and psychotherapy, but patients may prefer psychotherapeutic treatments. Despite the high prevalence, health anxiety is rarely diagnosed within primary care, and there is limited access to evidence-based treatment for health anxiety.\n\nAn easily accessible, evidence-based treatment is needed for this debilitating condition.\n\nInternet-based treatment is a new approach where patients receive access to a guided self-help program. A meta-analysis has shown equal treatment effects of internet-based treatment compared to "face-to-face" treatment for depressive- and anxiety disorders. Internet-based cognitive behavioral therapy for health anxiety has shown to be cost-effective. ACT is a new effective generation of cognitive-behavioral therapy, with an emphasis on acceptance and value-based exposure that has shown good results for treating health anxiety in a group setting. Internet-based Cognitive behavioral therapy (CBT) for health anxiety has shown promising results but low treatment completion. This may be due to the comprehensive treatment modules and the text-based format. ACT is an experiential behavioral therapy, and aims to activate patients with exercises, videos, audio-files and less text material.\n\nMost persons with health anxiety have high health care expenditure. However, some patients with health anxiety avoid contact to the health care system, and may not receive proper treatment. Patient self-referral is a new approach that may facilitate access to treatment.\n\nAim\n\n1. To develop an internet-delivered treatment program for patients suffering from health anxiety based on ACT.\n2. To test the feasibility and effectiveness of the treatment programme in a randomized, controlled trial, comparing treatment with an active control condition.\n\nHypothesis Primary hypothesis Patients with health anxiety treated with iACT will at 6-month follow-up report a significant reduction in illness worry compared to the action control condition iFORUM.\n\nSecondary hypotheses\n\nPatients with health anxiety treated with iACT compared to the active control condition iFORUM will at 6-month follow-up report:\n\n1. a reduction in physical symptoms and symptoms of anxiety and depression\n2. increased health-related quality of life\n3. more expedient illness perceptions and increased acceptance of symptoms\n\n Mediation analyses\n4. changes in illness perception and acceptance mediate the effect of iACT'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Severe health anxiety \\> 6 months\n2. Whiteley-7 score (scale 0-100 score points) corresponding to 21,4 or more.\n3. Age above 18 years old\n4. In case of a comorbid functional or other psychiatric disorder health anxiety must be the dominant problem\n5. Patients who speak, read and write Danish\n6. Access to a computer and internet access\n7. Residence in Denmark\n\nExclusion criteria:\n\n1. Acute suicidal risk\n2. Abuse of narcotics or alcohol and (non-prescribed) medicine\n3. Lifetime-diagnosis of psychoses, bipolar affective disorder or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)\n4. Pregnancy\n5. Unstable psychopharmacological treatment within last 2 months\n6. Former treatment at the Research Clinic for Functional Disorders and Psychosomatics\n7. Not providing informed consent'}, 'identificationModule': {'nctId': 'NCT02735434', 'briefTitle': 'Internet-delivered Acceptance and Commitment Therapy for Patients With Health Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Internet-delivered Acceptance and Commitment Therapy for Patients With Health Anxiety: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '09032016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet-based ACT', 'description': 'Brief clinical psychiatric assessment to determine eligibility (video-based).', 'interventionNames': ['Behavioral: Internet-based ACT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Internet-based discussion forum', 'description': 'Brief clinical psychiatric assessment to determine eligibility (video-based).', 'interventionNames': ['Other: Internet-based discussion forum']}], 'interventions': [{'name': 'Internet-based ACT', 'type': 'BEHAVIORAL', 'description': 'The guided internet program consists of 7 modules activated consecutively over a period of 12 weeks. The content is written psycho education, patient videos, audio-exercises and behavioural exposure exercises. The program is therapist-guided; hence all patients will receive support from primarily the same therapist during the 12 weeks.', 'armGroupLabels': ['Internet-based ACT']}, {'name': 'Internet-based discussion forum', 'type': 'OTHER', 'description': 'The online discussion forum consists of 7 themes touching upon the impact of health anxiety and the patients own coping strategies. The themes are activated consecutively over a period of 12 weeks. The discussion forum is text-based, and only patients will participate in the discussion. The written discussions will be reviewed by a professional for ethical reasons. The discussion forum aims to control for the effect of attention and contacts to the health care system. After 9 months patients in the discussion forum are offered active treatment, but not as part of the research project.', 'armGroupLabels': ['Internet-based discussion forum']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lisbeth Frostholm, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Charlotte U Rask, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Karolinska Institutet', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}