Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-30 @ 2:26 PM
Study NCT ID:
NCT06369532
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Neurostimulation and Psychotherapy to Stop Worrying
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Participants will be allocated into two groups randomly (using a code). The psychotherapist, the study managers and the patients will not be aware of treatment allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-12', 'studyFirstSubmitDate': '2024-01-22', 'studyFirstSubmitQcDate': '2024-04-12', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the therapeutic effect of the combination therapy for repetitive negative thinking', 'timeFrame': "Baseline, up to 7 weeks' therapy and up to 3 months' therapy", 'description': 'Questionnaires including the Penn State Worry Questionnaire (PSWQ, range 16-80), the Leuven adaptation of the rumination on sadness Scale (LARSS, range 21-105) , and the Ruminative Response Scale (RRS, range 22-88) will be used to measure the alteration of repetitive negative thinking. Higher scores suggest a higher level of worry or rumination. The Beck Depression Inventory (BDI), the Hamilton Depression Rating Scale (HDRS) and other related questionnaires will also be included.'}, {'measure': 'the consolidation effect of tDCS on CBT', 'timeFrame': "up to 7 weeks' therapy and up to 3 months' therapy", 'description': 'The Self-Critical Rumination scale (SCRS, range 0-40) and the Perseverative Thinking Questionnaire (PTQ, range 0-60) will be measures after each session (8 sessions in total). Higher scores suggest a higher level of self-critical ruminative thoughts or repetitive negative thinking.'}], 'secondaryOutcomes': [{'measure': 'Change of neuroimaging data', 'timeFrame': "Baseline and up to 3 months' therapy", 'description': 'The alteration of brain activity when performing cognitive task measured by EEG and emotional regulation task measured by fNIRS.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transcranial direct current stimulation'], 'conditions': ['Active tDCS', 'Sham tDCS']}, 'referencesModule': {'references': [{'pmid': '33621914', 'type': 'RESULT', 'citation': 'Baeken C, Wu GR, Rogiers R, Remue J, Lemmens GM, Raedt R. Cognitive behavioral based group psychotherapy focusing on repetitive negative thinking: Decreased uncontrollability of rumination is related to brain perfusion increases in the left dorsolateral prefrontal cortex. J Psychiatr Res. 2021 Apr;136:281-287. doi: 10.1016/j.jpsychires.2021.02.011. Epub 2021 Feb 13.'}, {'pmid': '30312634', 'type': 'RESULT', 'citation': 'Sathappan AV, Luber BM, Lisanby SH. The Dynamic Duo: Combining noninvasive brain stimulation with cognitive interventions. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Mar 8;89:347-360. doi: 10.1016/j.pnpbp.2018.10.006. Epub 2018 Oct 9.'}, {'pmid': '33232800', 'type': 'RESULT', 'citation': 'Dedoncker J, Baeken C, De Raedt R, Vanderhasselt MA. Combined transcranial direct current stimulation and psychological interventions: State of the art and promising perspectives for clinical psychology. Biol Psychol. 2021 Jan;158:107991. doi: 10.1016/j.biopsycho.2020.107991. Epub 2020 Nov 21.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate whether the combination of transcranial Direct Current Stimulation (tDCS) and cognitive-behavioral therapy (CBT) is more effective for treating repetitive negative thinking (RNT) in patients with the symptom of high rumination. High ruminators will be included (Group1, active tDCS-CBT group; Group2, sham tDCS-CBT group). All patients will receive active or sham tDCS.', 'detailedDescription': "A psychoeducational CBT-based group intervention called 'Drop It' specifically for the treatment of repetitive negative thinking (RNT), which has been proved to be effective in reducing RNT. tDCS is one of the emerging non-invasive brain stimulations techniques that can also be used to alter RNT. Our aim is to explore the therapeutic effect of this combination.\n\nThe study consists of 2 stages. In the first stage the participants will come to the university hospital for 7 weeks CBT sessions (the Drop It intervention), with one session per week. After each CBT session, both groups will receive sham or active tDCS. Stimulation will be applied for 30 min after the CBT session.\n\nIn the second stage, after the 7th weekly CBT session, participants will take the devices home to apply daily home-based tDCS stimulations for 4 weeks. After 4 weeks, participants will return to the university hospital for the final CBT session.\n\nNeuroimaging: Electroencephalogram (EEG) and functional Near-Infrared Spectroscopy (fNIRS) scan will be used to measure electrical activity and cortical hemodynamic activity in the brain. Both of these methods are non-invasive neuroimaging techniques which are done by placing electrodes on the scalp to pick up the signals produced by the brain.\n\nEEG and fNIRS scans will be performed at baseline and after 3 months therapy.\n\nTo examine the effect of the worry course combined with tDCS on thinking and acting, the investigators will ask the participants to complete various questionnaires that assess the nature and extent of worry, the presence of depressive complaints, the presence of anxiety problems and the extent of quality of life as experienced by the participants. Participants will also be evaluated by a psychiatrist from the service. This evaluation will take place at baseline, just after the end of the Drop It course and after a 3-month follow-up. Two questionnaires will also be used after each session to measure the state rumination following the combination therapy of CBT and tDCS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generalized anxiety disorder (GAD)\n* Depressive disorder\n\nExclusion Criteria:\n\n* other psychiatric pathology than GAD or depression screened by senior psychiatrist by means of the Mini-International Neuropsychiatric Interview (MINI) and psychiatric anamnesis\n* Abuse of alcohol, drugs or medication other than prescribed by general practitioner or psychiatrist\n* no consent to participate in measurement (questionnaire, fNIRS or EEG)\n* Insufficient knowledge of the current language (Dutch)\n* Acute or chronic suicidality\n* Acute psychosis or manic depressive disorder\n* Inability to commit to 8 sessions of Cognitive-Behavioral Therapy (CBT) or receive 4 weeks of transcranial Direct Current Stimulation (tDCS).'}, 'identificationModule': {'nctId': 'NCT06369532', 'briefTitle': 'Combination of Neurostimulation and Psychotherapy to Stop Worrying', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Stop Worrying, Learn to Let go Through a Combination of Neurostimulation and Psychotherapy', 'orgStudyIdInfo': {'id': 'ONZ-2023-0460'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active tDCS group', 'description': 'Patients will receive active tDCS during the therapy.', 'interventionNames': ['Device: Active tDCS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS group', 'description': 'Patients will receive sham tDCS during the therapy.', 'interventionNames': ['Device: Sham tDCS']}], 'interventions': [{'name': 'Active tDCS', 'type': 'DEVICE', 'description': 'During the whole therapy period, active tDCS group will receive active tDCS after CBT. They also receive active home-based tDCS.', 'armGroupLabels': ['Active tDCS group']}, {'name': 'Sham tDCS', 'type': 'DEVICE', 'description': 'The sham tDCS group will receive sham tDCS after CBT. They also receive sham home-based tDCS.', 'armGroupLabels': ['Sham tDCS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'East-Flanders', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Chris Baeken, Prof.', 'role': 'CONTACT'}, {'name': 'Josefien Dedoncker, M.Sc.', 'role': 'CONTACT'}], 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Chris Baeken', 'role': 'CONTACT', 'email': 'Chris.Baeken@ugent.be', 'phone': '+32476209841'}, {'name': 'Sara De Witte', 'role': 'CONTACT', 'email': 'sara.dewitte@ugent.be', 'phone': '+32498382824'}], 'overallOfficials': [{'name': 'Chris Baeken', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}