Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:26 AM
Study NCT ID:
NCT07464158
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
WRITE: Written Imaginal Thinking Exercise Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Social Phobia Inventory (SPIN)', 'timeFrame': 'Baseline through study completion, an average of 3 weeks.', 'description': 'Social anxiety symptom severity, range: 0-68 total, higher scores indicate higher social anxiety symptom severity.'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire (PHQ-8)', 'timeFrame': 'Baseline through study completion, an average of 3 weeks.', 'description': 'Depression symptom severity, range: 0-24 total, higher scores indicate higher depression symptom severity.'}, {'measure': 'Overall Anxiety Severity and Impairment Scale (OASIS)', 'timeFrame': 'Baseline through study completion, an average of 3 weeks.', 'description': 'General anxiety symptom severity, range: 0-20 total, higher scores indicate higher general anxiety symptom severity.'}, {'measure': 'Social Approach Motivation', 'timeFrame': 'Baseline through study completion, an average of 3 weeks.', 'description': 'Self-reported rating of motivation for social approach over the next week. Rating ranges from 0 (not motivated at all) to 100 (extremely motivated).'}, {'measure': 'Positive and Negative Affect Schedule (PANAS-10)', 'timeFrame': 'Baseline through study completion, an average of 3 weeks.', 'description': 'Positive and negative affect, range: 5-25 each (total score), higher scores indicate higher positive and negative affect.'}, {'measure': 'Cognitive Emotion Regulation Questionnaire (CERQ): Catastrophizing and Positive Reappraisal subscales', 'timeFrame': 'Baseline through study completion, an average of 3 weeks.', 'description': 'Use of catastrophizing and positive reappraisal cognitive emotion regulation strategies, range: 1-5 each (average score), higher score reflects higher degree of use of strategy.'}, {'measure': 'Threat-related prediction ratings', 'timeFrame': 'Baseline through study completion, an average of 3 weeks.', 'description': 'Self-reported ratings of 1) likelihood of feared situation avoidance, 2) likelihood of feared outcome occurrence, 3) predicted intensity of feared outcome occurrence, 4) likelihood of best possible outcome occurrence, and 5) predicted intensity of best possible outcome occurrence. All ratings range from 0 (0% likely/not bad at all/not good at all) to 100 (100% likely/as bad as I can possibly imagine/as good as I can possibly imagine).'}, {'measure': 'State emotion ratings', 'timeFrame': 'Baseline through study completion, an average of 3 weeks.', 'description': 'Self-reported state ratings of 1) positive affect, and 2) anxiety. All ratings range from 0 (not positive/anxious at all) to 100 (extremely positive/anxious).'}, {'measure': 'Writing exercise experience ratings - writing qualities', 'timeFrame': 'After each writing exercise, an average of 2 weeks.', 'description': 'Self-reported ratings of vividness/detail and effort of the writing. All ratings range from 0 (not at all) to 100 (extremely), higher scores reflect greater vividness/detail and effort.'}, {'measure': 'Writing exercise experience ratings - perceived learning', 'timeFrame': 'After each writing exercise, an average of 2 weeks.', 'description': 'Self-reported ratings of perceived learning and perspective shift from the writing exercises. All ratings range from 0 (strongly disagree) to 4 (strongly agree). Higher scores reflect greater perceived learning and perspective shift.'}, {'measure': 'Behavioral approach/avoidance', 'timeFrame': 'At the final study session, approximately 3 weeks after Baseline.', 'description': 'Single self-reported rating of willingness to engage in a feared situation. Binary yes/no response, where yes indicates willingness to approach and no indicates avoidance.'}, {'measure': 'Program feedback ratings - overall', 'timeFrame': 'At the final study session, approximately 3 weeks after Baseline.', 'description': 'Ratings assessing overall program feedback (range: 0-28, higher scores reflect more positive overall program feedback).'}, {'measure': 'Program feedback ratings - perceived benefit', 'timeFrame': 'At the final study session, approximately 3 weeks after Baseline.', 'description': 'Rating assessing perceived benefit of the writing exercises (range: 0-4, higher scores reflect higher perceived benefit).'}, {'measure': 'Program feedback ratings - likelihood of future use', 'timeFrame': 'At the final study session, approximately 3 weeks after Baseline.', 'description': 'Rating assessing likelihood of future use of writing exercises (range: 0-100, higher scores reflect higher likelihood of future use).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety', 'Stress', 'Social Anxiety']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate and compare the effects of three different versions of a future imaginal writing exercise (worst-case scenario, neutral future scenario, best-case scenario) for individuals with elevated social anxiety symptoms. Participants (N=270) will be recruited through the online platform, Prolific, and will be randomly assigned to one of three writing exercise conditions. Participants will complete three study sessions across approximately three weeks. Study session 1 (T1) will consist of baseline assessments and pre-writing ratings, a future imaginal writing exercise, and then post-writing ratings. Study session 2 (T2) will occur approximately one week later and will consist of mid-study assessments and pre-writing ratings, a second, repeated future imaginal writing exercise, and then post-writing ratings. Finally, study session 3 (T3) will occur approximately one week later (approximately two weeks after T1) and will consist of follow-up assessments and repeated post-writing ratings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English fluency\n* Previous high-quality Prolific submission experience\n* Elevated social anxiety symptoms\n\nExclusion Criteria:\n\n* Hospitalization for psychiatric reasons within the past year\n* Previous suicide attempt or self-harm\n* Previous treatment for severe head injury or past repeated serious head injury\n* Current psychosis symptoms\n* Elevated trauma symptoms'}, 'identificationModule': {'nctId': 'NCT07464158', 'acronym': 'WRITE', 'briefTitle': 'WRITE: Written Imaginal Thinking Exercise Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Boulder'}, 'officialTitle': 'Written Imaginal Thinking Exercise (WRITE) Study', 'orgStudyIdInfo': {'id': '25-0771'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Worst-Case Scenario', 'interventionNames': ['Behavioral: Worst-Case Scenario Written Exposure Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Neutral Future Scenario', 'interventionNames': ['Behavioral: Neutral Future Scenario Written Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Best-Case Scenario', 'interventionNames': ['Behavioral: Best-Case Scenario Written Exposure Exercise']}], 'interventions': [{'name': 'Worst-Case Scenario Written Exposure Exercise', 'type': 'BEHAVIORAL', 'description': 'Written exposure exercise about an imagined future worst-case scenario.', 'armGroupLabels': ['Worst-Case Scenario']}, {'name': 'Neutral Future Scenario Written Exercise', 'type': 'BEHAVIORAL', 'description': 'Written exercise about an imagined neutral future scenario.', 'armGroupLabels': ['Neutral Future Scenario']}, {'name': 'Best-Case Scenario Written Exposure Exercise', 'type': 'BEHAVIORAL', 'description': 'Written exposure exercise about an imagined future best-case scenario.', 'armGroupLabels': ['Best-Case Scenario']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Boulder', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral Associate', 'investigatorFullName': 'Nora Barnes-Horowitz', 'investigatorAffiliation': 'University of Colorado, Boulder'}}}}