Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT06130020
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-17
First Post:
2023-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Targets of Expressive Writing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 159}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2023-11-06', 'studyFirstSubmitQcDate': '2023-11-06', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sleep Quality', 'timeFrame': 'Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)', 'description': 'Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0-21, with higher scores indicating poorer sleep quality.'}, {'measure': 'Depression, Anxiety, and Stress', 'timeFrame': 'Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)', 'description': 'Depression, Anxiety, and Stress-21 (DASS-21). Scores for each of the three subscales range from 0-42, with higher scores indicating greater severity.'}, {'measure': 'Alexithymia (TAS)', 'timeFrame': 'Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)', 'description': 'Toronto Alexithymia Scale-20 (TAS-20). Scores range from 20-100, with higher scores indicating greater alexithymia.'}, {'measure': 'Alexithymia (PAQ)', 'timeFrame': 'Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)', 'description': 'Perth Alexithymia Questionnaire (PAQ). Total scores range from 24-168, with higher scores indicating greater alexithymia.'}, {'measure': 'Emotion Regulation', 'timeFrame': 'Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)', 'description': 'Emotion Regulation Questionnaire (ERQ). Scores for the reappraisal and suppression subscales range from 6-42 and 4-28 respectively. Higher scores indicate greater use of the strategy.'}, {'measure': 'Interpersonal Regulation', 'timeFrame': 'Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)', 'description': 'Interpersonal Regulation Questionnaire (IRQ). Total scores range from 16-112, with higher scores indicating greater tendency to use/efficacy of interpersonal emotion regulation.'}, {'measure': 'Social Desirability', 'timeFrame': 'Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)', 'description': 'Marlow-Crowne Social Desirability Scale (MC-SDS). Scores range from 0-33, with higher scores indicating greater social desirability.'}, {'measure': 'Social Connectedness', 'timeFrame': 'Initial visit (day 1), final visit (day 15), 1-month follow-up (1 month after day 14)', 'description': 'Social Connectedness Scale (SCS). Scores range from 8-48, with higher scores indicating greater connectedness to others.'}, {'measure': 'Daily Sleep', 'timeFrame': 'Daily from day 1 to day 14', 'description': 'Consensus Sleep Diary (CSD). Items are used to derive estimates of sleep indices, such as time in bed and total sleep time.'}, {'measure': 'Sleepiness', 'timeFrame': 'Daily from day 1 to day 14', 'description': 'Karolinska Sleepiness Scale (KSS). Scores on this single-item scale range from 1-10, with higher scores indicating greater sleepiness.'}], 'primaryOutcomes': [{'measure': 'Anxiety', 'timeFrame': 'Initial visit (day 1), mid-point (day 7) final visit (day 15), 1-month follow-up (1 month after day 14)', 'description': 'Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0-21, with higher scores indicating more severe anxiety.'}, {'measure': 'Depression', 'timeFrame': 'Initial visit (day 1), mid-point (day 7), final visit (day 15), 1-month follow-up (1 month after day 14)', 'description': 'Patient Health Questionnaire-8 (PHQ-8). Scores range from 0-24, with higher scores indicating more severe depression.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['expressive writing', 'journaling', 'mental health'], 'conditions': ['Healthy', 'Anxiety', 'Depression']}, 'referencesModule': {'references': [{'pmid': '3745650', 'type': 'BACKGROUND', 'citation': 'Pennebaker JW, Beall SK. Confronting a traumatic event: toward an understanding of inhibition and disease. J Abnorm Psychol. 1986 Aug;95(3):274-81. doi: 10.1037//0021-843x.95.3.274. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "Expressive writing involves writing about one's deepest thoughts and feelings surrounding an emotional event. The current literature on the efficacy of expressive writing is mixed and warrants further investigation into how, when, and for whom expressive writing is an effective intervention. The goal of this study is to compare the efficacy of expressive writing interventions in young adults when people imagine that they're writing to themselves vs. a loved one. Participants will carry out an expressive writing exercise for 14 consecutive days. Participants are randomized into 3 groups: Self, Other, and Control. The Self group is instructed to write as if they were talking to themselves. The Other group is instructed to direct their writing to someone they feel close to. The Control group is asked to write down a factual description of their routine that day, and direct this writing to themselves. We will recruit participants until we have usable data from 53 participants per group (i.e., 159 in total)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* US-based\n* Fluent English\n* Combined GAD-7 and PHQ-8 score of ≥ 5\n\nExclusion Criteria:\n\n* "Completion" of a writing session requires participants to spend at least 15 minutes on the writing page. We will monitor completion of the daily writing exercise, and will contact participants who miss or spend less than 15 minutes on the exercise. Participants who fail to complete 3 consecutive daily writing sessions will be deemed non-compliant, removed from the study, and paid a prorated amount for the tasks they have completed in the study.'}, 'identificationModule': {'nctId': 'NCT06130020', 'briefTitle': 'Comparing Targets of Expressive Writing', 'organization': {'class': 'OTHER', 'fullName': 'Trustees of Princeton University'}, 'officialTitle': 'Comparing Targets of Expressive Writing', 'orgStudyIdInfo': {'id': 'Princeton15734'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self', 'description': 'The Self group is instructed to carry out the expressive writing exercise as if they were writing to themselves.', 'interventionNames': ['Behavioral: Expressive Writing: Self']}, {'type': 'EXPERIMENTAL', 'label': 'Other', 'description': 'The Other group is instructed to carry out the expressive writing exercise as if they were writing to someone they feel close to.', 'interventionNames': ['Behavioral: Expressive Writing: Other']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'The Control group is asked to write down a factual description of their routine that day, as if they were writing to themselves.', 'interventionNames': ['Behavioral: Factual Writing']}], 'interventions': [{'name': 'Expressive Writing: Self', 'type': 'BEHAVIORAL', 'description': 'This intervention consists of a daily expressive writing exercise carried out for 14 consecutive days, for 15 minutes each day. Expressive writing involves asking participants to write about their deepest thoughts and feelings surrounding an emotional event. Participants in this condition will write as if they are writing to themselves.', 'armGroupLabels': ['Self']}, {'name': 'Expressive Writing: Other', 'type': 'BEHAVIORAL', 'description': "This intervention consists of a daily expressive writing exercise carried out for 14 consecutive days, for 15 minutes each day. Expressive writing involves asking participants to write about their deepest thoughts and feelings surrounding an emotional event. Participants in this condition will write as if they are writing/talking to someone they're close to.", 'armGroupLabels': ['Other']}, {'name': 'Factual Writing', 'type': 'BEHAVIORAL', 'description': 'This intervention consists of a daily factual writing exercise carried out for 14 consecutive days, for 15 minutes each day. Participants are asked to give a factual description of their day. This is a standard control for Expressive writing studies. Participants in this condition will be asked to direct their writing to themselves.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Peretsman Scully Hall', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}], 'overallOfficials': [{'name': 'Erik Nook, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Princeton University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Beginning after publication of results with no end date.', 'ipdSharing': 'YES', 'description': 'Upon study completion, a subset of the de-identified data will be transferred to OSF, which will provide public access to this data. Writing content will not be transferred to OSF, though we will make thoroughly de-identified data available to researchers who have completed appropriate ethics training, agree to confidentiality restrictions, and whose research goals are in line with the purpose of this study.', 'accessCriteria': 'A subset of the de-identified data will be publicly available on the OSF.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trustees of Princeton University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Erik Nook', 'investigatorAffiliation': 'Trustees of Princeton University'}}}}