Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-28 @ 9:56 PM
Study NCT ID:
NCT05551702
Status:
COMPLETED
Last Update Posted:
2025-03-28
First Post:
2022-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating Depression With Text Messaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to either the treatment group or the waitlist control group. The treatment group will receive 8 weeks of the text based intervention (CBT-txt) and complete surveys at baseline, 1 month, 2 months and 3 months. The waitlist control group will only do surveys at baseline, 1 month, 2 months, and 3 months and will then have the option of receiving the intervention after their 3 months of study participation.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2022-09-13', 'studyFirstSubmitQcDate': '2022-09-20', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Beck Depression Inventory II at 2 Months', 'timeFrame': 'Baseline, 1 Month, 2 Month, 3 Month', 'description': 'A 21-item instrument for measuring the severity of depression in adults and adolescents aged 13 years and older. Minimum score =0, Maximum=63. Higher scores indicate more depression.'}, {'measure': 'Change from Baseline Beck Depression Inventory II at 3 Months', 'timeFrame': 'Baseline, 1 Month, 2 Month, 3 Month', 'description': 'A 21-item instrument for measuring the severity of depression in adults and adolescents aged 13 years and older. Minimum score =0, Maximum=63. Higher scores indicate more depression.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Types of Thinking Cognitive Distortion Scale at 2 Months', 'timeFrame': 'Baseline, 1 Month, 2 Months, 3 Months', 'description': 'A 10 item scale using scenarios to help recognize cognitive distortions. Minimum score = 20, Maximum = 140. Higher scores equal more cognitive distortions.'}, {'measure': 'Change from Baseline Types of Thinking Cognitive Distortion Scale at 3 Months', 'timeFrame': 'Baseline, 1 Month, 2 Months, 3 Months', 'description': 'A 10 item scale using scenarios to help recognize cognitive distortions. Minimum score = 20, Maximum = 140. Higher scores equal more cognitive distortions.'}, {'measure': 'Change from Baseline Perseverative Thinking Questionnaire at 2 Months', 'timeFrame': 'Baseline, 1 Month, 2 Months, 3 Months', 'description': 'A 15 item scale rating statements about negative experiences or problems to identify repetitive negative thinking. Minimum score = 0, Max 60. Higher scores equal more perseverative thinking.'}, {'measure': 'Change from Baseline Perseverative Thinking Questionnaire at 3 Months', 'timeFrame': 'Baseline, 1 Month, 2 Months, 3 Months', 'description': 'A 15 item scale rating statements about negative experiences or problems to identify repetitive negative thinking. Minimum score = 0, Max 60. Higher scores equal more perseverative thinking.'}, {'measure': 'Change from Baseline Behavioral Activation for Depression Scale at 2 Months', 'timeFrame': 'Baseline, 1 Month, 2 Months, 3 Months', 'description': 'A 9 items scale to measure how and when participants become activated during behavioral activation treatment. Minimum score = 0, Max = 54. Higher scores equal more behavioral activation.'}, {'measure': 'Change from Baseline Behavioral Activation for Depression Scale at 3 Months', 'timeFrame': 'Baseline, 1 Month, 2 Months, 3 Months', 'description': 'A 9 items scale to measure how and when participants become activated during behavioral activation treatment. Minimum score = 0, Max = 54. Higher scores equal more behavioral activation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive Behavioral Therapy', 'Text-Based Intervention'], 'conditions': ['Moderate Depression']}, 'referencesModule': {'references': [{'pmid': '37432723', 'type': 'DERIVED', 'citation': 'Mason MJ, Coatsworth JD, Zaharakis N, Russell M, Brown A, McKinstry S. Testing Mechanisms of Change for Text Message-Delivered Cognitive Behavioral Therapy: Randomized Clinical Trial for Young Adult Depression. JMIR Mhealth Uhealth. 2023 Jul 11;11:e45186. doi: 10.2196/45186.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the research study is to investigate whether CBT-txt, a counseling program delivered by text messages is effective in stopping or reducing depressive symptoms. CBT-txt is based on a counseling program that has been proven to reduce depression when delivered in-person and on the web, but has not yet been tested or shown to be effective when delivered by text.', 'detailedDescription': 'After being informed about the study and potential risks, participants will complete online screening assessments. Once eligibility is confirmed, participants will be randomized either to the intervention group or to the waitlist-control group. Those who are randomized to the intervention group will receive the 8-week text intervention via smartphone and complete assessments at baseline, 1 month, 2 months, and 3 months. Those who are randomized to the waitlist-control group will only complete the assessments at baseline, 1 month, 2 months, and 3 months. Participants who are initially assigned to the waitlist-control group can choose to receive the text intervention once their 3-month participation is complete.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 25 years old\n* a score of at least 5 on the PHQ-9 (indicating elevated depression symptoms\n\nExclusion Criteria:\n\n* treatment for depression during the past three months\n* endorse suicide ideation on the PHQ-9\\*\n* lack of access to a text-capable phone\n* unable or unwilling to commit to two months of follow-up\n* not fluent in English.'}, 'identificationModule': {'nctId': 'NCT05551702', 'briefTitle': 'Treating Depression With Text Messaging', 'organization': {'class': 'OTHER', 'fullName': 'The University of Tennessee, Knoxville'}, 'officialTitle': 'Treating Depression With Text Delivered Counseling (Depression Study 2.0)', 'orgStudyIdInfo': {'id': 'Dep 2.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'This arm will receive 8 weeks of the text-based intervention (CBT-txt). CBT-txt is a version of Cognitive Behavioral Therapy tailored to be delivered by automated text message. This arm will also complete surveys at baseline, 1 month, 2 months, and 3 months.', 'interventionNames': ['Behavioral: CBT-txt']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist Control', 'description': 'This arm will not receive the text-based intervention during study participation. These participants will only complete surveys at baseline, 1 month, 2 months, and 3 months and will be given the option to receive CBT-txt after they complete study participation.'}], 'interventions': [{'name': 'CBT-txt', 'type': 'BEHAVIORAL', 'description': 'Cognitive Behavioral Therapy delivered via automated text messaging.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37996', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee-Knoxville', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'overallOfficials': [{'name': 'Michael J Mason, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tennessee-Knoxville'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Tennessee, Knoxville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Mason', 'investigatorAffiliation': 'The University of Tennessee, Knoxville'}}}}