Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 12:12 AM
Study NCT ID:
NCT07391020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-05
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Text Message Safety Behavior Fading for Pathological Worry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001326', 'term': 'Autogenic Training'}], 'ancestors': [{'id': 'D006990', 'term': 'Hypnosis'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'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': 'Participants are randomized to one of two conditions'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-29', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-01-29', 'lastUpdatePostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Penn State Worry Questionnaire (PSWQ; Meyer et al., 1990)', 'timeFrame': 'Day 0, Day 28, Day 56', 'description': 'Self-report scale that measures levels of worry. Scores range from 16 to 80 with higher scores indicating higher levels of worry.'}, {'measure': 'Worry Behaviors Inventory (Mahoney et al., 2016)', 'timeFrame': 'Day 0, Day 28, Day 56', 'description': 'Self-report scale that measures frequency of worry-related safety behavior use. Scores range from 0 to 44 with higher scores indicating more frequent worry-related safety behavior use.'}, {'measure': 'Generalized Anxiety Disorder Scale-7 (GAD-7; Spitzer et al., 2006)', 'timeFrame': 'Day 0, Day 28, Day 56', 'description': 'Self-report scale that measures generalized anxiety symptom severity. Scores range from 0 to 21, with higher scores indicating higher levels of generalized anxiety.'}, {'measure': 'Credibility and Expectancy Questionnaire (Devilly & Borkovec, 2000).', 'timeFrame': 'Day 0', 'description': 'Self-report scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies. Three items are rated on a 1-9 scale and one item is rated on a 0-100 scale with higher scores meaning greater expectancy and credibility.'}, {'measure': 'Theoretical Framework of Acceptability Questionnaire (TFA; Sekhon et al., 2022)', 'timeFrame': 'Day 28', 'description': 'Self-report scale for measuring treatment acceptability. Each item is rated on a 1-5 scale measuring agreement with each statement. For four items, higher scores reflect higher levels of acceptability. For the remaining four items, higher scores reflect lower levels of acceptability. Scores for each subscale range from 4-20.'}], 'secondaryOutcomes': [{'measure': 'Center for Epidemiologic Studies Depression Scale-10 (CESD; Andreson, 1994)', 'timeFrame': 'Day 0, Day 28, Day 56', 'description': 'Self-report measure of depression symptom severity. Each item is rated on a 0 to 3 scale. Total scores range from 0 to 30 with higher scores indicating greater depression severity.'}, {'measure': 'NIH Toolbox Fear - Somatic Arousal Scale (Pilkonis et al., 2013)', 'timeFrame': 'Day 0, Day 28, Day 56', 'description': 'Self-report scale measuring levels of anxious somatic arousal. Scores range from 6 to 30, with higher scores indicating higher levels of anxious arousal.'}, {'measure': 'Intolerance of Uncertainty Scale - 12 item version (IUS-12; Carleton et al., 2007)', 'timeFrame': 'Day 0, Day 28, Day 56', 'description': 'Self-report scale that measures intolerance of uncertainty. Scores range from 12 to 60 with higher scores indicating higher levels of intolerance of uncertainty.'}, {'measure': 'Short Scale Anxiety-Sensitivity Index (SSASI; Zvolensky et al., 2018)', 'timeFrame': 'Day 0, Day 28, Day 56', 'description': 'Self-report scale that measures anxiety sensitivity. Scores range from 0 to 20, with higher scores indicating higher levels of anxiety sensitivity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['safety behaviors', 'worry'], 'conditions': ['Generalized Anxiety Disorder (GAD)', 'Worrying', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'The current study aims to explore the efficacy of a text message-based Safety Behavior Fading Intervention compared to a PMR control condition.', 'detailedDescription': 'Safety behavior fading intervention procedures will follow methodology previously used in the Cougle Lab. The safety behavior fading intervention is designed to target a decrease or elimination of worry-related safety behaviors.\n\nIndividuals randomly assigned to the safety behavior fading condition will receive instructions to decrease or eliminate their endorsed worry behaviors. In addition, they will receive daily reminders via text message to decrease these behaviors, along with a worry behavior monitoring checklist in which the participant indicates the extent to which they decreased and/or eliminated each safety behavior over the previous day. Participants will also be able to track their progress using daily progress charts that show how their daily total safety behavior use changes throughout treatment. Text messaging will be managed by EZTexting - a service that manages mass texting protocols. The daily reminder will include the following language: "Hi! This is a friendly reminder to avoid using your checklist behaviors. Please tap the link below to access today\'s checklist: \\[link to checklist\\]." Individuals randomly assigned to the PMR condition will receive a total of 4 videos over the course of a month (1 video per week, 15 minutes each) wherein participants will be invited to systematically tense and release different muscle groups in the body in order to build awareness of tension and relaxation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Elevated worry as defined by a score of 60 or higher on the PSWQ.\n\nExclusion Criteria:\n\n* Score of 59 or lower on the PSWQ\n* If applicable, unstable psychiatric medication usage any time over the past 4 weeks\n* Failing attention checks in baseline data collection\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT07391020', 'briefTitle': 'Text Message Safety Behavior Fading for Pathological Worry', 'organization': {'class': 'OTHER', 'fullName': 'Florida State University'}, 'officialTitle': 'Safety Behavior Fading Intervention for Pathological Worry', 'orgStudyIdInfo': {'id': 'STUDY00005991'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Safety Behavior Fading', 'description': 'Individuals randomly assigned to the safety behavior fading condition will receive instructions to decrease or eliminate their endorsed worry behaviors. In addition, they will receive daily reminders via text message to decrease these behaviors, along with a worry behavior monitoring checklist in which the participant indicates the extent to which they decreased and/or eliminated each safety behavior over the previous day. Participants will also be able to track their progress using daily progress charts that show how their daily total safety behavior use changes throughout treatment.', 'interventionNames': ['Behavioral: Safety Behavior Fading for Pathological Worry']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Progressive Muscle Relaxation (PMR)', 'description': 'Individuals randomly assigned to the PMR condition will receive a total of 4 videos over the course of a month (1 video per week, 15 minutes each) wherein participants will be invited to systematically tense and release different muscle groups in the body in order to build awareness of tension and relaxation.', 'interventionNames': ['Behavioral: Progressive Muscle Relaxation (PMR)']}], 'interventions': [{'name': 'Safety Behavior Fading for Pathological Worry', 'type': 'BEHAVIORAL', 'description': 'Participants are asked to reduce or eliminate safety behaviors via text message reminders, daily checklist, and daily progress chart to monitor progress.', 'armGroupLabels': ['Safety Behavior Fading']}, {'name': 'Progressive Muscle Relaxation (PMR)', 'type': 'BEHAVIORAL', 'description': 'Participants are asked watch weekly videos lasting 15 minutes each that walk them through a progressive muscle relaxation exercise.', 'armGroupLabels': ['Progressive Muscle Relaxation (PMR)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32304', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'contacts': [{'name': 'Matthew Sala, B.S.', 'role': 'CONTACT', 'email': 'sala@psy.fsu.edu', 'phone': '850-645-8729'}, {'name': 'Jesse Cougle, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Florida State University', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}], 'centralContacts': [{'name': 'Matthew Sala, B.S.', 'role': 'CONTACT', 'email': 'sala@psy.fsu.edu', 'phone': '850-645-8729'}], 'overallOfficials': [{'name': 'Jesse Cougle, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Florida State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Florida State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jesse Cougle', 'investigatorAffiliation': 'Florida State University'}}}}