Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:38 PM
Study NCT ID:
NCT07478393
Status:
RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Readiness and Progress in Emotion Regulation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079562', 'term': 'Rumination Syndrome'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-12', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Weekly Assessment of Change in Disability/Impairment', 'timeFrame': 'Baseline, 1st Treatment Session, Follow-Up (4 weeks)', 'description': 'The Sheehan Disability Scale (SDS) is a 4-item scale which assesses impairment in work, social life/leisure activity, family life/home responsibilities, and overall functioning. Higher scores on this measure indicate greater impairment.'}, {'measure': 'Weekly Assessment of Change in Life Satisfaction', 'timeFrame': 'Baseline, 1st Treatment Session, Follow-Up (4 weeks)', 'description': "The Brief Multidimensional Students' Life Satisfaction Scale (BMSLSS) is a 5-item scale assessing a participant's satisfaction within a number of domains regarding their social and occupational functioning. Higher scores on this measure indicate greater life satisfaction."}, {'measure': 'Weekly Assessment of Change in Behavioral Dysregulation', 'timeFrame': 'Baseline, 1st Treatment Session, Follow-Up (4 weeks)', 'description': 'The Behavior Dysregulation Scale (BDRS) is a 9-item self-report measure of behavioral emotion dysregulation.'}], 'primaryOutcomes': [{'measure': 'Weekly Assessment of Change in Attentional Control', 'timeFrame': 'Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)', 'description': 'The Attentional Control Scale (ACS) is a 21-item measure used to measure difficulties with concentration associated with problems regulating emotions. The focusing and shifting subscales of the ACS align with the two attention emotion regulation (ER) skills taught in ERT.'}, {'measure': 'Weekly Assessment of Change in Decentering', 'timeFrame': 'Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)', 'description': "The decentering subscale of the Experiences Questionnaire (EQ-D) is an 11-item subscale assessing one's ability to distance themselves from their emotional experience, which is one metacognitive ER skill taught during ERT. Higher scores on this subscale indicate better ability to distancing oneself from one's emotional experience."}, {'measure': 'Weekly Assessment of Change in Reappraisal', 'timeFrame': 'Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)', 'description': 'The reappraisal subscale of the Emotion Regulation Questionnaire (ERQ) is a 6-item measure of the ability to regulate emotions, using the strategy of reappraisal. Higher scores on this subscale indicate a better ability to regulate emotions using the strategy of reappraisal.'}, {'measure': 'Weekly Assessment of Change in Valued Living/Action', 'timeFrame': 'Baseline, 1st Treatment Session, Follow-Up (4 weeks)', 'description': 'The Valuing Questionnaire (VQ) is a 10-item measure of the degree to which patients live by their values in daily life. It uses a 7-point Likert scale (0-6) to assess progress and obstructions to valued living. Higher scores on this measure indicate more valued living.'}, {'measure': 'Weekly Assessment of Change in Clarity of Approach-Avoidance Motivation', 'timeFrame': 'Baseline, 1st Treatment Session, Follow-Up (4 weeks)', 'description': 'The Mental Representation of Approach Avoidance Questionnaire (MRAAQ) is a 42-item self-report assessment designed to capture the mental representation of approach-avoidance motivation.'}, {'measure': 'Weekly Assessment of Change in Rumination', 'timeFrame': 'Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)', 'description': 'The Rumination-Reflection Questionnaire (RRQ) is a 12-item measure that assesses past-focused rumination with specificity regarding the types of rumination that people may experience. Higher scores on this measure indicate greater rumination.'}, {'measure': 'Weekly Assessment of Change in Worry', 'timeFrame': 'Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)', 'description': 'The Penn State Worry Questionnaire - Past Week (PSWQ-PW) is an adapted version of the original PSWQ, contains 15 items (rated on a 0-6 scale), and assesses the extent to which worry has been excessive, uncontrollable, and pervasive in the past week. Higher scores on this measure indicate greater worry in the past week.'}, {'measure': 'Weekly Assessment of Change in Self-Criticism', 'timeFrame': 'Weekly from Baseline (2 weeks) through Treatment (12-22 weeks) and Follow-Up (4 weeks)', 'description': 'The self-judgment subscale of the Self-Compassion Scale (SCS) contains 5-items and assesses the tendency to self-criticize. Higher scores on this measure indicate greater self-criticism.'}], 'secondaryOutcomes': [{'measure': 'Weekly Assessment of Change in Depression Severity', 'timeFrame': 'Baseline, 1st Treatment Session, Follow-Up (4 weeks)', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Emotional Distress - Depression - Short Form 8a will be administered to assess for depression severity. Higher scores on this measure indicate greater depression severity.'}, {'measure': 'Weekly Assessment of Change in Anxiety Severity', 'timeFrame': 'Baseline, 1st Treatment Session, Follow-Up (4 weeks)', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank - Emotional Distress - Anxiety - Short Form 8a will be administered to assess for anxiety severity. Higher scores on this measure indicate greater anxiety severity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Worry', 'Rumination', 'Self-Criticism', 'Emotion Regulation Therapy', 'Emotion Regulation', 'Treatment Mechanisms'], 'conditions': ['Rumination', 'Worry', 'Self-Criticism', 'Anxiety', 'Depression', 'Distress, Emotional']}, 'descriptionModule': {'briefSummary': 'This study is an open trial designed to examine individual changes that occur before, during, and after 6 modules of Emotion Regulation Therapy (ERT) delivered via telehealth for individuals in New York State who are experiencing elevated worry, rumination, or self-criticism.', 'detailedDescription': 'The main questions this study aims to answer are to:\n\n1. Examine temporal patterns of ERT-specific treatment mechanisms (attention regulation, metacognitive regulation, motivation regulation, and valued living), relationships between these mechanisms and negative self-referential processing (NSRP; i.e., rumination, worry, and self-criticism) severity over time, and changes in these mechanisms in response to specific intervention strategies/modules.\n2. Investigate the effect of concordance and/or discordance between therapists and clients regarding skill acquisition, treatment goals, and case conceptualizations on treatment mechanisms as well as measures of treatment outcome and satisfaction.\n3. Demonstrate the preliminary efficacy of a 6-module, time-variable version of ERT in reducing symptoms of psychological distress (e.g., anxiety, depression, worry, rumination, self-criticism), changing ERT-specific treatment mechanisms (e.g., attention regulation), and improving quality of life and overall functioning.\n\nParticipants will:\n\n1. Fill out an online pre-screening questionnaire and complete a structured clinical interview via Zoom Healthcare\n2. Be enrolled as a patient at the Dean Hope Center for Educational and Psychological Services (DHCEPS), located at Teachers College\n3. Attend between 12-22 once-weekly telehealth ERT sessions\n4. Complete between 18-28 weekly questionnaires online via Qualtrics (two before starting treatment, 12-22 during each week of treatment, and 4 after ending treatment).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18 and 65\n* Fluent in English (and therefore able to provide consent)\n* Currently living in New York State\n* Access to at least one device with internet and video-conferencing capabilities\n* High self-reported worry, rumination, and/or self-criticism\n* Meet Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for at least one, current psychological disorder\n\nExclusion Criteria:\n\n* Active suicidal ideation or intent\n* Substance dependence disorder, schizophrenia, bipolar-I disorder, or a primary DSM-5 diagnosis of borderline or narcissistic personality disorder\n* Currently in therapy or receiving any type of psychosocial treatment\n* Individuals taking psychotropic mediation that has not been stabilized for a period of at least 3 months\n* Current students at Teachers College, Columbia University'}, 'identificationModule': {'nctId': 'NCT07478393', 'briefTitle': 'Readiness and Progress in Emotion Regulation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Teachers College, Columbia University'}, 'officialTitle': 'Readiness and Progress in Emotion Regulation Therapy', 'orgStudyIdInfo': {'id': '25-453'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'All participants will receive a 6-module, time-variable version of Emotion Regulation Therapy delivered weekly via synchronous telehealth using videoconferencing software and an asynchronous Internet-based online platform to supplement the content covered in each session.', 'interventionNames': ['Behavioral: Emotion Regulation Therapy via Telehealth']}], 'interventions': [{'name': 'Emotion Regulation Therapy via Telehealth', 'type': 'BEHAVIORAL', 'otherNames': ['Emotion Regulation Therapy (ERT)'], 'description': "The initial stage of treatment focuses on psychoeducation about anxiety/depression, the impact that these cognitions/behaviors/emotions have on recent situations, and self-monitoring of worry/anxiety/depression. The sessions focus on the development of skills that help understand and regulate one's emotional experience (i.e., recognizing emotions when they are happening, identifying the meaning of a given emotion experience, soothing oneself in the context of negative emotional experiences). Following the development of these skills, sessions focus on the application of somatic awareness and emotion regulation skills while imagining emotionally evocative themes. The remaining session focuses on terminating therapy, relapse prevention, and future goals. An Internet-based online platform will be used to promote engagement with and increase accessibility to between-session skills practice and treatment-related activities (e.g., self-monitoring, session summaries, worksheets).", 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10027', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Douglas S Mennin, PhD', 'role': 'CONTACT', 'email': 'mennin@tc.columbia.edu', 'phone': '212-678-6609'}], 'facility': 'Teachers College, Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Douglas S Mennin', 'role': 'CONTACT', 'email': 'mennin@tc.columbia.edu', 'phone': '212.678.6609'}, {'name': 'Moises Hernandez', 'role': 'CONTACT', 'email': 'emotionregulationtherapy@gmail.com', 'phone': '212.678.6609'}], 'overallOfficials': [{'name': 'Douglas S Mennin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Clinical Psychology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teachers College, Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical Psychology, Director of Clinical Training', 'investigatorFullName': 'Douglas Mennin', 'investigatorAffiliation': 'Teachers College, Columbia University'}}}}