Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT06183333
Status:
RECRUITING
Last Update Posted:
2023-12-27
First Post:
2023-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of a Web-Based Emotion Regulation Training in a Transdiagnostic Sample
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080103', 'term': 'Emotional Regulation'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001883', 'term': 'Borderline Personality Disorder'}], 'ancestors': [{'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010554', 'term': 'Personality Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Clinical interviews and data analysis will be conducted blindly.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial with an Intervention Group and a Waiting List Control Group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2023-12-13', 'studyFirstSubmitQcDate': '2023-12-13', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Implicit Emotion Regulation Capacity', 'timeFrame': '4 weeks', 'description': 'Responses to negative images (corrugator electromyogram, frontal alpha asymmetry, affect ratings) and heart rate variability during a laboratory resting period (Thayer \\& Lane, 2000)'}, {'measure': 'Negative Emotion Downregulation Ability', 'timeFrame': '4 weeks', 'description': 'Changes in responses to negative images (corrugator electromyogram, frontal alpha asymmetry, affect ratings) following a downregulation instruction in a laboratory emotion regulation task (adapted from Ertl et al., 2013)'}, {'measure': 'Positive Emotion Upregulation Ability', 'timeFrame': '4 weeks', 'description': 'Changes in responses to positive images (corrugator electromyogram, frontal alpha asymmetry, affect ratings) following an upregulation instruction in a laboratory emotion regulation task (adapted from Cheng et al., 2023)'}], 'primaryOutcomes': [{'measure': 'Changes in Emotion Regulation Difficulties', 'timeFrame': '0 weeks, 4 weeks, 8 weeks', 'description': 'The Difficulties in Emotion Regulation Scale (DERS; Gratz \\& Roemer, 2004)'}], 'secondaryOutcomes': [{'measure': 'Changes in Emotion Regulation Strategy Use', 'timeFrame': '0 weeks, 4 weeks, 8 weeks', 'description': 'The Heidelberg Form for Emotion Regulation Strategies (HFERST; Izadpanah et al., 2019)'}, {'measure': 'Changes in Well-Being', 'timeFrame': '0 weeks, 4 weeks, 8 weeks', 'description': 'The World Health Organization Well-Being Index (WHO-5; Topp et al., 2015)'}, {'measure': 'Changes in Anxiety Symptoms', 'timeFrame': '0 weeks, 4 weeks, 8 weeks', 'description': 'The General Anxiety Disorder Scale (GAD-7; Spitzer et al., 2006)'}, {'measure': 'Changes in Depressive Symptoms', 'timeFrame': '0 weeks, 4 weeks, 8 weeks', 'description': 'The Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)'}, {'measure': 'Changes in Eating Psychopathology', 'timeFrame': '0 weeks, 4 weeks, 8 weeks', 'description': 'The Eating Disorders Examination Questionnaire (EDE-Q; Berg et al., 2012)'}, {'measure': 'Changes in Personality Pathology', 'timeFrame': '0 weeks, 4 weeks, 8 weeks', 'description': 'The Personality Inventory for DSM-5 (PID-5; Krueger et al., 2012)'}, {'measure': 'Changes in Eating-Disorder-Related Daily Difficulties', 'timeFrame': '0 weeks, 4 weeks, 8 weeks', 'description': 'The Clinical Impairment Assessment Questionnaire (CIA; Bohn et al., 2008)'}, {'measure': 'Changes in Self-Esteem', 'timeFrame': '0 weeks, 4 weeks, 8 weeks', 'description': 'The Rosenberg Self-Esteem Scale (RSES; Roth et al., 2008)'}, {'measure': 'Changes in Weekly Emotion Regulation Strategy Use', 'timeFrame': '0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks', 'description': 'Weekly assessment of emotion regulation strategies (adapted from Pruessner et al., 2023).'}, {'measure': 'Changes in Weekly Positive and Negative Affect', 'timeFrame': '0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks', 'description': 'Positive and Negative Affect Schedule - Expanded Form (16 items; PANAS-X; Watson \\& Clark, 1994)'}, {'measure': 'Changes in Weekly Eating Psychopathology', 'timeFrame': '0 weeks, 1 weeks, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks', 'description': 'The Eating Disorders Examination Questionnaire (EDE-QS; Gideon et al., 2016)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Internet-Based Intervention', 'Web-Based Training', 'Emotion Regulation'], 'conditions': ['Emotion Regulation', 'Anxiety Disorders', 'Depression', 'Eating Disorders', 'Borderline Personality Disorder']}, 'referencesModule': {'references': [{'pmid': '25774638', 'type': 'BACKGROUND', 'citation': 'Ritschel LA, Tone EB, Schoemann AM, Lim NE. Psychometric properties of the Difficulties in Emotion Regulation Scale across demographic groups. Psychol Assess. 2015 Sep;27(3):944-54. doi: 10.1037/pas0000099. Epub 2015 Mar 16.'}, {'pmid': '28730850', 'type': 'BACKGROUND', 'citation': 'Izadpanah S, Barnow S, Neubauer AB, Holl J. Development and Validation of the Heidelberg Form for Emotion Regulation Strategies (HFERST): Factor Structure, Reliability, and Validity. Assessment. 2019 Jul;26(5):880-906. doi: 10.1177/1073191117720283. Epub 2017 Jul 21.'}, {'pmid': '25831962', 'type': 'BACKGROUND', 'citation': 'Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.'}, {'pmid': '16717171', 'type': 'BACKGROUND', 'citation': 'Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.'}, {'pmid': '11556941', 'type': 'BACKGROUND', 'citation': 'Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.'}, {'pmid': '22279527', 'type': 'BACKGROUND', 'citation': 'Hilbert A, de Zwaan M, Braehler E. How frequent are eating disturbances in the population? Norms of the eating disorder examination-questionnaire. PLoS One. 2012;7(1):e29125. doi: 10.1371/journal.pone.0029125. Epub 2012 Jan 18.'}, {'pmid': '24511899', 'type': 'BACKGROUND', 'citation': 'Zimmermann J, Altenstein D, Krieger T, Holtforth MG, Pretsch J, Alexopoulos J, Spitzer C, Benecke C, Krueger RF, Markon KE, Leising D. The structure and correlates of self-reported DSM-5 maladaptive personality traits: findings from two German-speaking samples. J Pers Disord. 2014 Aug;28(4):518-40. doi: 10.1521/pedi_2014_28_130. Epub 2014 Feb 10.'}, {'pmid': '32849049', 'type': 'BACKGROUND', 'citation': 'Roth M, Altmann T. A Comparison of the Predictive Validity of Self-Esteem Level and Directly Measured Self-Esteem Stability in the Temporal Prediction of Psychological Distress. Front Psychol. 2020 Jul 24;11:1770. doi: 10.3389/fpsyg.2020.01770. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'This two-armed randomized controlled trial investigates the efficacy of a web-based emotion regulation intervention in a transdiagnostic sample. The sample includes participants diagnosed with anxiety disorders, depression, eating disorders, borderline personality disorder, and healthy controls without a current psychiatric diagnosis. Participants will be randomly assigned to either the intervention group, receiving a web-based emotion regulation program, or a waitlist control group, which will have delayed intervention access after eight weeks.\n\nThe intervention is grounded in cognitive-behavioral therapy (CBT), featuring everyday emotion regulation exercises, and psychoeducation delivered through video and audio files. Outcome measures include emotion regulation abilities, well-being, anxiety, depression, eating disorder symptoms, personality pathology, and self-esteem, evaluated at four and eight weeks post-baseline.', 'detailedDescription': 'Background:\n\nEmotion regulation is pivotal in the pathogenesis and persistence of diverse psychopathologies. While anxiety disorders are often marked by an impaired ability to modulate acute fear responses, depressive disorders feature enduring negative affect and frequent rumination. In eating disorders, emotional dysregulation typically leads to maladaptive coping via disordered eating behaviors, whereas in borderline personality disorder, it manifests as emotional instability. The pervasiveness of emotion regulation difficulties across these diverse clinical presentations highlights a need for treatments targeting this shared mechanism. Our study aims to address this gap by testing the effectiveness of a novel web-based emotion regulation intervention in a transdiagnostic sample.\n\nMethod:\n\nThis two-armed randomized controlled trial involves participants aged 18 and above diagnosed with anxiety disorders, depression, eating disorders, borderline personality disorder, and healthy controls without psychiatric diagnoses. Participants will be randomly assigned to one of two groups:\n\n1. Web-based emotion regulation intervention.\n2. Waitlist control group with delayed intervention access (eight weeks).\n\nThe intervention, accessible via mobile phones or desktop browsers, employs cognitive-behavioral therapy (CBT) techniques, offering everyday emotion regulation exercises and psychoeducation through video material and audio files.\n\nOutcome measures, including emotion regulation abilities, well-being, anxiety, depression, eating disorder symptoms, personality pathology, and self-esteem, will be assessed at four and eight weeks post-baseline.\n\nHypotheses:\n\nThe intervention is expected to result in improved emotion regulation abilities and well-being, along with reduced anxiety, depression, eating disorder symptoms, personality pathology, and self-esteem compared to the waitlist control group. The transdiagnostic intervention is anticipated to demonstrate superiority in addressing the diverse emotional challenges across different psychological disorders.\n\nAdditional Laboratory Study:\n\nA subgroup of participants will be invited for a follow-up laboratory assessment of physiological indicators of emotion regulation abilities four weeks after their initial baseline measurement. We hypothesize that the intervention will lead to notable improvements in implicit emotion regulation capacity measured during a resting period and the presentation of negative emotional images. Furthermore, we anticipate observable improvements in explicit emotion regulatory skills, specifically in the downregulation of negative emotions and the upregulation of positive emotions, as assessed through a picture-viewing paradigm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sufficient German language skills (C1)\n* Permanent internet access during the study period\n* ≥ 18 years of age\n\nExclusion Criteria:\n\n* Acute suicidality\n* Current severe substance use disorder\n* Current severe depressive episode\n* Lifetime bipolar disorder\n* Lifetime psychotic disorders\n* Body Mass Index (BMI) below 18.5'}, 'identificationModule': {'nctId': 'NCT06183333', 'briefTitle': 'Efficacy of a Web-Based Emotion Regulation Training in a Transdiagnostic Sample', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Efficacy of a Web-Based Emotion Regulation Training in a Transdiagnostic Sample: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ER-Training'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Web-based emotion regulation intervention', 'interventionNames': ['Behavioral: Heidelberg Emotion Regulation Training']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control group', 'description': 'Eight-week waiting period'}], 'interventions': [{'name': 'Heidelberg Emotion Regulation Training', 'type': 'BEHAVIORAL', 'description': "The four-week intervention program is specifically designed to enhance the participants' emotion regulation. It focuses on developing their skills in accurately recognizing various emotions and effectively applying diverse emotion regulation strategies. To achieve this, the program includes video-based psychoeducation sessions. Alongside these sessions, the program incorporates daily short exercises, each lasting approximately five minutes. These exercises are crafted to help participants practically integrate the concepts and strategies learned from the psychoeducation sessions into their everyday lives. All components of the intervention are accessible through an online platform, ensuring ease of access and flexibility for participants.", 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69117', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Heidelberg University', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Steffen Hartmann', 'role': 'CONTACT', 'email': 'steffen.hartmann@psychologie.uni-heidelberg.de', 'phone': '+496221 / 54 7295'}, {'name': 'Luise Pruessner', 'role': 'CONTACT', 'email': 'luise.pruessner@psychologie.uni-heidelberg.de', 'phone': '+49 6221 / 54 7282'}], 'overallOfficials': [{'name': 'Steffen Hartmann', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychology, Heidelberg University'}, {'name': 'Luise Pruessner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Psychology, Heidelberg University'}, {'name': 'Sven Barnow, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Psychology, Heidelberg University'}, {'name': 'Daniel V. Holt, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Psychology, Heidelberg University'}]}, 'ipdSharingStatementModule': {'url': 'http://osf.io', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be made available after the publication of the study results.', 'ipdSharing': 'YES', 'description': 'De-identified dataset', 'accessCriteria': 'Open access, available upon request to ensure appropriate use.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Luise Pruessner', 'investigatorAffiliation': 'Heidelberg University'}}}}