Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-29 @ 9:26 AM
Study NCT ID:
NCT06570603
Status:
RECRUITING
Last Update Posted:
2025-07-10
First Post:
2024-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeting Components of Distress Tolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2024-05-07', 'studyFirstSubmitQcDate': '2024-08-21', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Engagement behaviors', 'timeFrame': 'Assessed 5x/day via ecological momentary assessment', 'description': 'Emotion regulation strategies reflective of engagement; these are new items developed for this study and are not from an established scale. All items will be rated from 0 (not at all) to 6 (extremely). There will be 7 items assessing labeling ("I\'m using emotion words to describe how I feel right now"), processing ("I\'m reflecting on or writing about my feelings"), sharing ("I\'m sharing how I feel with another person"), physical feeling ("I\'m intentionally feeling my feelings in my body"), curiously considering ("I\'m curiously considering how my feelings came about"), defusion ("I\'m observing my feelings without getting \'stuck\' in them"), and importance ("I\'m trying to think about how this current situation maps on to what matters.")'}, {'measure': 'Disengagement behaviors', 'timeFrame': 'Assessed 5x/day via ecological momentary assessment', 'description': 'Emotion regulation strategies reflective of disengagement, some of which were modified from a momentary experiential avoidance measure (Hershenberg et al., 2017). All items will be rated from 0 (not at all) to 6 (extremely).Items will assess distraction ("Trying to distract myself from my feelings\'), thought suppression ("Trying to push unwanted thoughts out of my mind."), discounting ("I\'m telling myself I shouldn\'t be feeling the way I\'m feeling"), expressive suppression ("I\'m trying to control my feelings by not expressing them"), procrastination ("I\'m intentionally putting of an unpleasant task until later"), denial ("I\'m trying to \'turn off\' the feelings that I don\'t want to feel"), and reduce importance ("Trying to think about the current situation as unimportant to me.")'}, {'measure': 'GAD-7', 'timeFrame': 'Baseline, weekly for three weeks and then after one month followup', 'description': 'Symptoms of anxiety'}, {'measure': 'PHQ-9', 'timeFrame': 'Baseline, weekly for three weeks and then after one month followup', 'description': 'symptoms of depression'}, {'measure': 'AUDIT', 'timeFrame': 'Baseline, weekly for three weeks and then after one month followup', 'description': 'Alcohol misuse'}, {'measure': 'Binge Eating Disorder Scale', 'timeFrame': 'Baseline, weekly for three weeks and then after one month followup', 'description': 'binge eating symptoms'}, {'measure': 'DSM Cross-Cutting Symptom Measure', 'timeFrame': 'Baseline, weekly for three weeks and then after one month followup', 'description': 'symptoms of psychopathology'}], 'secondaryOutcomes': [{'measure': 'Satisfaction with Life Scale (SWLS)', 'timeFrame': 'Baseline, weekly for three weeks and then after one month followup', 'description': 'life satisfaction'}, {'measure': 'Self-Compassion Scale - Short', 'timeFrame': 'Baseline, weekly for three weeks and then after one month followup', 'description': 'self-criticism and self-compassion'}, {'measure': 'State Loss of Interest and Pleasure Scale', 'timeFrame': 'Baseline, weekly for three weeks and then after one month followup', 'description': 'anhedonia'}, {'measure': 'Rumination and Reflection Questionnaire', 'timeFrame': 'Baseline, weekly for three weeks and then after one month followup', 'description': 'rumination and self-reflective tendencies'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Distress, Emotional']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn which aspects of distress intolerance (i.e., difficulties withstanding upsetting emotional states) are the most important for improving effective emotion regulation and associated mental health symptoms.\n\nThe main questions it aims to answer are:\n\nHow are willingness to feel upset and self-efficacy for withstanding distress associated with different emotion regulation strategies used in daily life?\n\nDoes targeting willingness to feel upset and/or self-efficacy for withstanding distress help people use more effective emotion regulation strategies in daily life when they feel upset?\n\nAre improvements in emotion regulation strategies in daily life associated with fewer symptoms of mental health problems over time?\n\nParticipants will:\n\nAnswer questions about their moods, willingness to feel upset, self-efficacy for withstanding distress and emotion regulation strategies for three weeks using a cell phone app\n\nUndergo a willingness, self-efficacy, combined or psychoeducational control intervention in the lab\n\nBe prompted to use the intervention skill via the cell phone app during the second week, after the intervention\n\nComplete weekly reports of mental health symptoms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fluent in English\n* Uses Android or iPhone smartphone\n* Depression Anxiety and Stress Scale (DASS-21) scores of 42 and higher\n* Distress Intolerance Index (DII) scores of 3 or higher\n\nExclusion Criteria:\n\n* Work or School that does not allow consistent access to phone (or is unsafe)\n* No internet access for completing follow-up surveys'}, 'identificationModule': {'nctId': 'NCT06570603', 'briefTitle': 'Targeting Components of Distress Tolerance', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas, Fayetteville'}, 'officialTitle': 'Targeting Components of Distress Tolerance', 'orgStudyIdInfo': {'id': '1R15MH136626-01', 'link': 'https://reporter.nih.gov/quickSearch/1R15MH136626-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Psychoeducational Control', 'description': 'Participants will receive psychoeducation only', 'interventionNames': ['Behavioral: Psychoeducation']}, {'type': 'EXPERIMENTAL', 'label': 'Self-Efficacy (Only)', 'description': 'Single session intervention focusing on increasing self-efficacy to manage distress. Will include brief psychoeducation about emotion, then a focus on agency and self-criticism, using stressors the participant provided from the previous week, with an aim to teach self-compassion skills that will improve self-efficacy.', 'interventionNames': ['Behavioral: Self-Efficacy', 'Behavioral: Psychoeducation']}, {'type': 'EXPERIMENTAL', 'label': 'Willingness (Only)', 'description': 'Single session intervention focused on increasing willingness to allow distress. Will include brief psychoeducation about emotion, then a discussion of values and how allowing and experiencing emotions nourishes values, experiencing discomfort enhances growth. Will use stressors from the prior week as examples.', 'interventionNames': ['Behavioral: Willingness', 'Behavioral: Psychoeducation']}, {'type': 'EXPERIMENTAL', 'label': 'Combined Willingness and Self-Efficacy', 'description': 'Single session intervention focused on increasing both willingness and self-efficacy. Will include brief psychoeducation about emotion, then a combination of using values and self-compassion to increase both allowing and self-efficacy.', 'interventionNames': ['Behavioral: Self-Efficacy', 'Behavioral: Willingness', 'Behavioral: Psychoeducation']}], 'interventions': [{'name': 'Self-Efficacy', 'type': 'BEHAVIORAL', 'description': 'Brief skills based psychotherapy session to increase perceived self-efficacy for withstanding distress, giving participants increased beliefs that they \\*can\\* do it.', 'armGroupLabels': ['Combined Willingness and Self-Efficacy', 'Self-Efficacy (Only)']}, {'name': 'Willingness', 'type': 'BEHAVIORAL', 'description': 'Brief skills based psychotherapy session to increase perceived willingness to engage with distress for withstanding distress, giving participants increased motivation to try.', 'armGroupLabels': ['Combined Willingness and Self-Efficacy', 'Willingness (Only)']}, {'name': 'Psychoeducation', 'type': 'BEHAVIORAL', 'description': 'Psychoeducation about the components and functions of emotion.', 'armGroupLabels': ['Combined Willingness and Self-Efficacy', 'Psychoeducational Control', 'Self-Efficacy (Only)', 'Willingness (Only)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72701', 'city': 'Fayetteville', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Arkansas - Fayetteville', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}], 'centralContacts': [{'name': 'Jennifer C Veilleux, PhD', 'role': 'CONTACT', 'email': 'jcveille@uark.edu', 'phone': '479-575-5329'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas, Fayetteville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jennifer C Veilleux', 'investigatorAffiliation': 'University of Arkansas, Fayetteville'}}}}