Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-29 @ 4:25 PM
Study NCT ID:
NCT06153303
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2023-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-based ACT for Endometriosis and Chronic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064869', 'term': 'Acceptance and Commitment Therapy'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-04', 'studyFirstSubmitDate': '2023-10-13', 'studyFirstSubmitQcDate': '2023-11-22', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain interference as measured by the Multidimensional Pain Inventory (MPI)', 'timeFrame': 'Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), two-week-post treatment, 3 month-follow- up', 'description': '(changes between assessments) Min= 0; Max= 6. Higher scores indicate worse interference.'}], 'secondaryOutcomes': [{'measure': 'Psychological inflexibility as measured by the Psychological Inflexibility in Pain Scale (PIPS)', 'timeFrame': 'Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), two-week-post treatment, 3 month-follow- up', 'description': '(changes between assessments) (changes between assessments) Min=0; Max= 52. Higher scores indicate worse inflexibility'}, {'measure': 'Anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Baseline, two-week-post treatment, 3 month-follow- up', 'description': '(changes between assessments) Min= 0; Max= 21. Higher scores indicate worse depression/anxiety.'}, {'measure': 'Pain intensity as measured by the Numerical Rating Scale (NRPS)', 'timeFrame': 'Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), two-week-post treatment, 3 month-follow- up', 'description': '(changes between assessments) Min= 0; Max= 10. Higher scores indicate worse pain intensity.'}, {'measure': 'Pain catastrophizing as measured by the Pain Catastrophizing Questionnaire (PCS)', 'timeFrame': 'Baseline, mid-treatment (3 weeks), mid-treatment (5 weeks), two-week-post treatment, 3 month-follow- up', 'description': '(changes between assessments) Min= 0; Max= 52. Higher scores indicate worse pain catastrophizing.'}, {'measure': 'Perceived health as measured by the RAND-36 Measure of Health-Related Quality of Life (RAND-36)', 'timeFrame': 'Baseline, two-week-post treatment, 3 month-follow- up', 'description': '(changes between assessments)Min= 0; Max= 100. Lower scores indicate worse perceived health.'}, {'measure': 'Kinesiophobia as measured by the Tampa Scale of Kinesiophobia (Tampa)', 'timeFrame': 'Baseline, two-week-post treatment, 3 month-follow- up', 'description': '(changes between assessments) Min= 17; Max= 68. Higher scores indicate worse kinesiophobia'}, {'measure': 'Health care utilization as measured by the health-care database of Region Skåne', 'timeFrame': 'Baseline, 3 month-follow- up', 'description': '(changes between assessments)'}, {'measure': 'Health-related quality of life as measured by the Endometriosis Health Profile (EHP-30)', 'timeFrame': 'Baseline, two-week-post treatment, 3 month-follow- up', 'description': '(changes between assessments) Min=0; Max= 100. Lower scores indicate better health-related quality of life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endometriosis', 'chronic pain'], 'conditions': ['Endometriosis', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy for endometriosis and chronic pain. A pilot study (no randomization; N=10) will be conducted to test the intervention and assessment procedures. The participants will go through an active internet-based ACT treatment focused on education about endometriosis and chronic pain, value-based exposure for avoided situations, and behavior change through exercises targeting the processes mindfulness, cognitive defusion and acceptance. The treatment is delivered on a safe internet platform. Participants have planned telephone contact with their assigned psychologist 2 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours.', 'detailedDescription': "Objective The primary aim of this study is to investigate the effect of Internet-delivered Acceptance and commitment therapy (iACT)for endometriosis.\n\nSample size 10 participants.\n\nTrial design All participants are offered treatment. Participants are recruited from the Pain Rehabilitation Unit and the team for endometriosis at Skåne University Hospital. The unit is a government supported, regional specialist center focused on assessment and treatment of chronic pain and related disability.\n\nAssessments Baseline and posttreatment (2 weeks after treatment) assessments will be conducted. Self-report measures will also be collected at baseline, post-treatment as well as during a 3-month follow up.\n\nAssessment includes:Pre-and post assessment Assessors collected demographic information and self-report measures. During the pre-assessment the Mini International Neuropsychiatric Interview 5.0 (MINI) was administered to detect the presence of other comorbid disorders and assess inclusion criteria and rule out exclusion criteria.\n\nDuring treatment During treatment the treatment credibility scale was administered to assess the patients' perceptions of how credible the treatment was following the introduction of the treatment rationale and the main treatment components (included in the internet program).\n\nSafety parameters: As a mean to monitor safety and progress participants complete self-report measures (MPI, NRS, PIPS, PCS) and a question about suicidal ideation twice during the program and the therapist can follow these scores. In addition, participants can report any adverse events during treatment, at posttreatment and follow-up assessment.\n\nPost-treatment exit interview At the post-assessment, the assigned assessor asked participants about their satisfaction with and experience of the program, what they found helpful or unhelpful and suggestions for future improvements.\n\nMeasures were taken at baseline, 2-weeks, 3 months follow-up. Self-report measures were mailed to participants\n\nMain statistical analysis Between-group estimates on outcome will be conducted using repeated measurements. The analyses will be conducted using intention to treat principles and post hoc comparisons."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* verified endometriosis\n* age between 18-65 years\n* were fully examined medically and had received medical treatment if indicated\n* were able to be an active part of the rehabilitation process, regain functioning in different life areas and participate in treatment interventions for approximately 5 hours every week\n* stable dose of medication\n* able to read and write in Swedish\n* had access to a smart phone or computer with internet access\n\nExclusion Criteria:\n\n* had acute or severe psychiatric disorders or symptoms that warranted designation as the primary disorder (ongoing substance dependence, untreated bipolar disorder, OCD, psychotic symptoms, severe depression, PTSD)\n* were actively abusing analgesic medications (including narcotics), alcohol or other drugs\n* had great difficulty to harbour and handle strong emotions that could lead to emotional outbursts or self-harming behavior\n* had health risks due to medical reasons;\n* had social or economic difficulties or lack of social support that hindered behavior change\n* current severe suicidal ideation that warranted immediate intervention (indicated by the MINI and a score of 3 to item 9 of the Patient Health Questionnaire 9-item version (PHQ9))'}, 'identificationModule': {'nctId': 'NCT06153303', 'briefTitle': 'Internet-based ACT for Endometriosis and Chronic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Skane University Hospital'}, 'officialTitle': 'A Pilot Study of Internet-based ACT for Endometriosis and Chronic Pain', 'orgStudyIdInfo': {'id': 'SkaneU3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment group', 'description': 'Acceptance and commitment therapy', 'interventionNames': ['Behavioral: Acceptance and commitment therapy']}], 'interventions': [{'name': 'Acceptance and commitment therapy', 'type': 'BEHAVIORAL', 'description': 'The participants will go through an active internet-based ACT treatment focused on education about endometriosis and chronic pain, value-based exposure for avoided situations, and behavior change through exercises targeting the processes mindfulness, cognitive defusion and acceptance. The treatment is delivered on a safe internet platform. Participants have planned telephone contact with their assigned psychologist 2 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours.', 'armGroupLabels': ['treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22241', 'city': 'Lund', 'state': 'Skåne County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Sophia Åkerblom, PhD', 'role': 'CONTACT', 'email': 'sophia.akerblom@skane.se'}], 'facility': 'Skåne unviersity Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'centralContacts': [{'name': 'Sophia Åkerblom, PhD', 'role': 'CONTACT', 'email': 'sophia.akerblom@skane.se', 'phone': '004646171520'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skane University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Sophia Åkerblom', 'investigatorAffiliation': 'Skane University Hospital'}}}}