Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-02 @ 3:06 AM
Study NCT ID:
NCT06887751
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2025-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Acceptability of an Online ACT Intervention for Disorders of Gut-Brain Interaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a pilot study (feasibility including acceptability) in which we intend to see how the prototype intervention and overall workload (including measurements) is perceived by the participants.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2025-03-06', 'studyFirstSubmitQcDate': '2025-03-13', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Individual Interviews', 'timeFrame': 'At post treatment (8 weeks)', 'description': 'Feasibility and Acceptability of intervention'}], 'secondaryOutcomes': [{'measure': 'The Generalized Anxiety Disorder scale-7 (GAD-7)', 'timeFrame': 'At pre and post treatment (0 and 8 weeks), 6-month follow-up (FU1), and 12-month follow-up (FU2) assessments', 'description': 'Symptoms of general anxiety'}, {'measure': 'EQ-5D-5L', 'timeFrame': 'At pre and post treatment (0 and 8 weeks)', 'description': 'Health-related Quality of Life'}, {'measure': 'AQoL-8D', 'timeFrame': 'At pre and post treatment (0 and 8 weeks)', 'description': 'Health-related Quality of Life'}, {'measure': 'The Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)', 'timeFrame': 'At pre and post treatment (0 and 8 weeks)', 'description': 'Healthcare Utilization'}, {'measure': 'The Gastrointestinal Symptom Rating Scale (GSRS)', 'timeFrame': 'At pre and post treatment (0 and 8 weeks)', 'description': 'Symptom Severity of DGBI'}, {'measure': 'The Chronic Illness Shame Scale (CISS)', 'timeFrame': 'At pre and post treatment (0 and 8 weeks)', 'description': 'Shame of Chronic Illnesses:'}, {'measure': 'The Credibility / Expectancy Questionnaire (CEQ)', 'timeFrame': 'After session 2 (2 weeks)', 'description': 'Treatment Credibility and Expectancy'}, {'measure': 'The System Usability Scale (SUS)', 'timeFrame': 'At post treatment (8 weeks)', 'description': 'Intervention Platform Usability'}, {'measure': 'The Negative Effects Questionnaire (NEQ-20)', 'timeFrame': 'At post treatment (8 weeks)', 'description': 'Negative Side Effects and Events'}, {'measure': 'The Intervention Acceptability Scale', 'timeFrame': 'At post treatment (8 weeks)', 'description': 'Intervention Acceptability'}, {'measure': 'The Contextual Therapies Process Awareness Scale', 'timeFrame': 'At post treatment (8 weeks)', 'description': 'Awareness of Processes'}, {'measure': 'The Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'At pre and post treatment (0 and 8 weeks)', 'description': 'symptoms of depression'}, {'measure': 'The Multidimensional Psychological Flexibility Inventory (MPFI)', 'timeFrame': 'At pre and post treatment (0 and 8 weeks)', 'description': 'Psychological flexibility'}, {'measure': 'The State Self-Compassion Scale - short Form (SSCS-S)', 'timeFrame': 'At pre and post treatment (0 and 8 weeks)', 'description': 'state self-compassion'}, {'measure': 'The Self-Compassion Scale - short Form (SCS-SF)', 'timeFrame': 'At pre and post treatment (0 and 8 weeks)', 'description': 'trait self-compassion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['DGBI', 'Depression/Anxiety']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to assess the acceptability, feasibility, and usability of the iACTforDGBI intervention among patients with Disorders of Gut-Brain Interaction (DGBI). The main question it aims to answer are:\n\nWhat are the perceptions of patients with DGBI and healthcare practitioners regarding the acceptability, feasibility, and usability of the iACTforDGBI intervention?\n\nParticipants will be asked to:\n\nComplete the iACTforDGBI intervention prototype, consisting of self-guided online sessions.\n\nParticipate in online interviews and fill out online questionnaires to evaluate the intervention concerning acceptability, feasibility, usability and preliminary effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 and 75 years\n2. Meeting clinical symptom levels for least one DGBI diagnosis (assessed with the Rome IV Diagnostic Questionnaire for Functional Gastrointestinal Disorders in Adults (Palsson et al., 2016))\n3. Clinically meaningful levels of depressive symptoms or anxiety: score ≥ 13 on the Montgomery Åsberg Depression Rating Scale (Svanborg \\& Åsberg, 1994; (MADRS-S; depressive symptoms), or score ≥ 10 on the Generalized Anxiety Disorder scale-7 (GAD-7; anxiety symptoms; Spitzer et al., 2006)\n4. Stable medication for psychiatric symptoms including anxiety, depression and sleep problems for at least two months prior to intervention.\n5. Ability to read and write Swedish\n6. Have access to a device (like computer, tablet or smartphone with) with access to the internet and that can be used to attend video conferences and preview the intervention platform (i.e., have a microphone and speakers or headphones).\n\nExclusion Criteria:\n\n1. Currently undergoing any form of psychological intervention.\n2. Increased risk of suicide (≥4 points on MADRS item 9)\n3. Severe depression (\\>34 points on MADRS)'}, 'identificationModule': {'nctId': 'NCT06887751', 'acronym': 'iACTforDGBI', 'briefTitle': 'Feasibility and Acceptability of an Online ACT Intervention for Disorders of Gut-Brain Interaction', 'organization': {'class': 'OTHER', 'fullName': 'Örebro University, Sweden'}, 'officialTitle': 'Development, Feasibility, Efficacy, and Cost-effectiveness of an Online ACT Intervention for Disorders of Gut-Brain Interaction (Substudy 2)', 'orgStudyIdInfo': {'id': '2023-00741b'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acceptance and Commitment Therapy (ACT)', 'description': 'Acceptance and Commitment Therapy (ACT)', 'interventionNames': ['Behavioral: Acceptance and Commitment Therapy (ACT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Psychoeducation', 'description': 'Psychoeducation', 'interventionNames': ['Other: Psychoeducation']}], 'interventions': [{'name': 'Acceptance and Commitment Therapy (ACT)', 'type': 'BEHAVIORAL', 'description': 'The self-guided Online version of Acceptance and Commitment Therapy (iACTforDGBI) intervention will include 8 weekly sessions of around 20 minutes each, and will comprise ACT-consistent informative texts, audio exercises, and videos.\n\nThe intervention is expected to have the following overall structure: Session 1: Introduction to the intervention and promotion of creative hopelessness, Awareness of bodily sensations, Values clarification Session 2: Committed action, Acceptance, Cognitive defusion Session 3: Self as context, Conclusions Session 4-8: personalised content (in-depth material and tasks based on individual difficulties assessed with diary)', 'armGroupLabels': ['Acceptance and Commitment Therapy (ACT)']}, {'name': 'Psychoeducation', 'type': 'OTHER', 'description': 'Participants in the active control group will be asked to complete 8 weekly 20-minute sessions of an online course for education on DGBIs. This course will be delivered through a similar platform than the one delivering the online ACT for DGBI intervention, via the same website. The intervention platform will have similar designs and structure, and will be developed by the same web development company.\n\nThe content of the education course will be based on the IBS school intervention (e.g., Ringström et al., 2009), in particular its online version (Lindfors et al., 2021), developed by members of the current research team. This education intervention was based on the biopsychosocial model of DGBI and was originally developed and tested as a face-to-face group intervention with six 2-h sessions held weekly. IBS school generally aims at increasing disease knowledge in people with IBS and covers a wide spectrum of issues related to IBS, such as disease pathophysiological me', 'armGroupLabels': ['Psychoeducation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Örebro', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Inês Trindade, PhD', 'role': 'CONTACT', 'email': 'ines.almeidatrindade@gmail.com', 'phone': '+46 0763463867'}], 'facility': 'Örebro University', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'centralContacts': [{'name': 'Inês A Trindade, Phd', 'role': 'CONTACT', 'email': 'ines.trindade@oru.se', 'phone': '+4619302264'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'This question is under investigation. Some of our data contain sensitive information on health, and the main priority is participants integrity which need to be balanced against basic scientific principles on scrutiny. However, any personal data that can be shared without compromising participants integrity to a reasonable degree will be shared upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Örebro University, Sweden', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, {'name': 'Göteborg University', 'class': 'OTHER'}, {'name': 'Uppsala University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}