Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-27 @ 10:47 PM
Study NCT ID:
NCT06273995
Status:
RECRUITING
Last Update Posted:
2025-07-20
First Post:
2024-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telehealth Behavioral Activation for Teens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single group, open-label behavioral activation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-18', 'studyFirstSubmitDate': '2024-02-13', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Health Questionnaire 9-modified for adolescents (PHQ-A)', 'timeFrame': 'During treatment (every session (week) 1-10)', 'description': 'Depression; 4-point Likert scale (0= Not at all; 3= Nearly every day), Score range 0-27 (higher scores indicate greater depression severity)'}, {'measure': 'Behavioral Activation for Depression-Short Form (BAD-SF)', 'timeFrame': 'During treatment (every session (week) 1-10)', 'description': 'Behavioral Activation; 6-point Likert scale (0= Not al all; 6= Completely), Score range 0-54 (higher scores indicate higher activation)'}, {'measure': 'Dimensional Anhedonia Rating Scale (DARS)', 'timeFrame': 'Baseline (before treatment), post-treatment (session/week 11)', 'description': 'Anhedonia; 5-point Likert scale (0= Not at all; 4= Very much), Score range 0- 68 (higher scores indicate less anhedonia)'}], 'secondaryOutcomes': [{'measure': 'Strengths and Difficulties Questionnaire (SDQ)', 'timeFrame': 'Baseline (before treatment), post-treatment (session/week 11)', 'description': 'Behavioral screening; 3-point Likert scale (0= Not at all; 2= Certainly True), Score range 0-40 (higher scores indicate more difficulties)'}, {'measure': 'Duke Social Support Index (DSSI)', 'timeFrame': 'Baseline (before treatment), post-treatment (session/week 11)', 'description': 'Social Support; Multiple Likert scales ((1 = None; 3= More than 2 people)(1= Hardly ever; 3= Most of the time)), Score range 10 -20 (higher scores indicate a higher level of social support)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['behavioral activation', 'depression', 'adolescents'], 'conditions': ['Depression', 'Suicide and Self-harm', 'Depression in Adolescence', 'Depression Mild', 'Depression Moderate', 'Depression Severe']}, 'referencesModule': {'references': [{'pmid': '37088508', 'type': 'BACKGROUND', 'citation': 'Anvari MS, Hampton T, Tong MP, Kahn G, Triemstra JD, Magidson JF, Felton JW. Behavioral Activation Disseminated by Non-Mental Health Professionals, Paraprofessionals, and Peers: A Systematic Review. Behav Ther. 2023 May;54(3):524-538. doi: 10.1016/j.beth.2022.12.007. Epub 2022 Dec 23.'}, {'pmid': '32758528', 'type': 'BACKGROUND', 'citation': 'Copeland WE, Alaie I, Jonsson U, Shanahan L. Associations of Childhood and Adolescent Depression With Adult Psychiatric and Functional Outcomes. J Am Acad Child Adolesc Psychiatry. 2021 May;60(5):604-611. doi: 10.1016/j.jaac.2020.07.895. Epub 2020 Aug 3.'}, {'pmid': '33054915', 'type': 'BACKGROUND', 'citation': 'Curtin SC. State Suicide Rates Among Adolescents and Young Adults Aged 10-24: United States, 2000-2018. Natl Vital Stat Rep. 2020 Sep;69(11):1-10.'}, {'pmid': '34663534', 'type': 'BACKGROUND', 'citation': 'Daly M. Prevalence of Depression Among Adolescents in the U.S. From 2009 to 2019: Analysis of Trends by Sex, Race/Ethnicity, and Income. J Adolesc Health. 2022 Mar;70(3):496-499. doi: 10.1016/j.jadohealth.2021.08.026. Epub 2021 Oct 16.'}, {'pmid': '35312475', 'type': 'BACKGROUND', 'citation': 'Garnett MF, Curtin SC, Stone DM. Suicide Mortality in the United States, 2000-2020. NCHS Data Brief. 2022 Mar;(433):1-8.'}, {'pmid': '20677369', 'type': 'BACKGROUND', 'citation': 'Kanter JW, Manos RC, Bowe WM, Baruch DE, Busch AM, Rusch LC. What is behavioral activation? A review of the empirical literature. Clin Psychol Rev. 2010 Aug;30(6):608-20. doi: 10.1016/j.cpr.2010.04.001.'}, {'pmid': '35285883', 'type': 'BACKGROUND', 'citation': "Lebrun-Harris LA, Ghandour RM, Kogan MD, Warren MD. Five-Year Trends in US Children's Health and Well-being, 2016-2020. JAMA Pediatr. 2022 Jul 1;176(7):e220056. doi: 10.1001/jamapediatrics.2022.0056. Epub 2022 Jul 5."}, {'pmid': '25602170', 'type': 'BACKGROUND', 'citation': 'McCauley E, Gudmundsen G, Schloredt K, Martell C, Rhew I, Hubley S, Dimidjian S. The Adolescent Behavioral Activation Program: Adapting Behavioral Activation as a Treatment for Depression in Adolescence. J Clin Child Adolesc Psychol. 2016;45(3):291-304. doi: 10.1080/15374416.2014.979933. Epub 2015 Jan 20.'}, {'type': 'BACKGROUND', 'citation': 'Reinert, M, Fritze, D. & Nguyen, T. (2021). "The State of Mental Health in America 2022"'}, {'type': 'BACKGROUND', 'citation': 'Ritschel, L. A., Ramirez, C. L., Cooley, J. L., & Craighead, W. E. (2016). Behavioral activation for major depression in adolescents: Results from a pilot study. Clinical Psychology: Science and Practice, 23, 39-57. https://doi.org/10.1111/cpsp.12140'}, {'pmid': '33051037', 'type': 'BACKGROUND', 'citation': 'Trombello JM, South C, Sanchez A, Kahalnik F, Kennard BD, Trivedi MH. Two Trajectories of Depressive Symptom Reduction Throughout Behavioral Activation Teletherapy Among Underserved, Ethnically Diverse, Primary Care Patients: A VitalSign6 Report. Behav Ther. 2020 Nov;51(6):958-971. doi: 10.1016/j.beth.2020.01.002. Epub 2020 Jan 11.'}, {'pmid': '32628293', 'type': 'BACKGROUND', 'citation': 'Uphoff E, Ekers D, Robertson L, Dawson S, Sanger E, South E, Samaan Z, Richards D, Meader N, Churchill R. Behavioural activation therapy for depression in adults. Cochrane Database Syst Rev. 2020 Jul 6;7(7):CD013305. doi: 10.1002/14651858.CD013305.pub2.'}]}, 'descriptionModule': {'briefSummary': "Behavioral activation is one such empirically supported intervention. Derived from cognitive-behavioral therapy, a well-established treatment for depression, behavioral activation uses psychoeducation and skill-building to increase an individual's engagement in valued and enjoyable activities (e.g., socializing with family and friends, exercising, participating in a hobby) in order to improve depressive symptoms. Research has shown that behavioral activation is an effective intervention for depressed youth. Additionally, it has been shown as a promising intervention that can be conducted in a brief, virtual format and can be effectively implemented by both trained clinicians and trained, non-licensed interventionists. This project will provide Behavioral Activation for youth (12-17) experiencing depression or suicidal ideation who are currently enrolled in the Youth Depression Suicide Network study in Texas.", 'detailedDescription': "Rates of youth depression and suicide are rising worldwide and present a critical public health problem. Between 2007 and 2018, rates of fatal suicide among U.S. youth and young adults increased by 57.4%, becoming the second leading cause of all deaths for Americans between the ages of 10 and 34 in 2020. Similarly, between 2009 and 2019, rates of past year major depressive episodes among adolescents in the United States increased from 8.1% to 15.8% (roughly 1 in 6). Despite these high rates of suicide and depression, Texas is rated 51st in access to mental healthcare in the United States. As untreated youth depression tends to persist and has been related to poorer functioning in adulthood, there is a need to increase access to empirically supported treatment for depressed adolescents.\n\nBehavioral activation is one such empirically supported intervention. Derived from cognitive-behavioral therapy, a well-established treatment for depression, behavioral activation uses psychoeducation and skill-building to increase an individual's engagement in valued and enjoyable activities (e.g., socializing with family and friends, exercising, participating in a hobby) in order to improve depressive symptoms. Research has shown that behavioral activation is an effective intervention for depressed youth. Additionally, it has been shown as a promising intervention that can be conducted in a brief, virtual format and can be effectively implemented by both trained clinicians and trained, non-licensed interventionists."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants must be enrolled in the Texas Youth Depression Suicide Research Network (TX-YDSRN) Registry Study;\n2. Be between the ages of 12- 18 or currently enrolled in high school;\n3. Have a caregiver that is willing to participate in the program;\n4. Be able to commit to weekly sessions for eight weeks;\n5. Be currently experiencing depressive symptoms;\n6. Be able to participate in telehealth services within the state of Texas;\n7. Be willing to provide consent/assent (parents/legally authorized representative (LAR)/guardian or young adult participant, aged 18 or older, must be willing to provide consent; youth, aged 12-17, must be willing to provide assent);\n8. Be able to read, write and speak English or Spanish sufficiently to understand the study procedures and provide written informed consent to participate in the study;\n9. Be willing to dedicate appropriate time to complete scheduled study assessment and measures and attend intervention sessions (both parent/LAR/guardian and youth)\n10. Be able to provide a reliable means of contact.\n\nExclusion Criteria:\n\n1. Have an acute medical or psychological condition(s) that that would, in the judgment of the study medical clinician, make participation difficult or unsafe;\n2. Have an acute medical or psychological condition(s) that would result in an inability to accurately complete study requirements (e.g., neurological conditions or significant neurodevelopmental concerns);\n3. Have active psychotic or manic symptoms resulting in altered mental status and inability to provide assent or requiring immediate attention and/or higher level of intervention;\n4. Have a parent/LAR/guardian who is deemed cognitively unable to provide consent (if youth participant, aged 12-17).'}, 'identificationModule': {'nctId': 'NCT06273995', 'briefTitle': 'Telehealth Behavioral Activation for Teens', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Telehealth Behavioral Activation for Teens', 'orgStudyIdInfo': {'id': 'H-54233'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral Activation (BA)', 'description': "Behavioral activation is one such empirically supported intervention. Derived from cognitive-behavioral therapy, a well-established treatment for depression, behavioral activation uses psychoeducation and skill-building to increase an individual's engagement in valued and enjoyable activities (e.g., socializing with family and friends, exercising, participating in a hobby) in order to improve depressive symptoms", 'interventionNames': ['Other: Behavioral Activation']}], 'interventions': [{'name': 'Behavioral Activation', 'type': 'OTHER', 'description': 'All participants will undergo behavioral activation treatment for 8-10 weeks', 'armGroupLabels': ['Behavioral Activation (BA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eric Storch, Ph.D.', 'role': 'CONTACT', 'email': 'eric.storch@bcm.edu', 'phone': '713-798-3080'}], 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Emily Bivins, B.S.', 'role': 'CONTACT', 'email': 'emily.bivins@bcm.edu', 'phone': '713-798-1709'}, {'name': 'Eric Storch, Ph.D.', 'role': 'CONTACT', 'email': 'eric.storch@bcm.edu', 'phone': '(713) 798-3579'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Texas', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eric A Storch', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}