protocolSection identificationModule nctId: NCT06322849, orgStudyIdInfo id: STU00220591, briefTitle: Active Elements of Digital Single-session Interventions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, descriptionModule briefSummary: Depression is a leading cause of disability in young adults. However, access to care is limited due to structural and psychological barriers. Single-session interventions (SSIs) are structured programs designed to maximize the therapeutic output in one interaction between the patient and the provider or a program. Project ABC, a single-session intervention (SSI), has been shown to be effective in reducing depressive symptoms. Project ABC is based on four components-psychoeducation, testimonials, saying is believing exercises, and action planning. However, it is unclear what are the effects of the individual components.The primary aim of this study is to calculate the main effects of the candidate components-psychoeducation, testimonials + saying is believing exercises, and action planning-on Patient Health Questionnaire-8 (PHQ-8) scores at 8-week follow-up.The secondary aims of this study are to:1. calculate the main effects of the candidate components-psychoeducation, testimonials + saying is believing exercises, and action planning-on PHQ-8 scores at immediate post-treatment and 2-week follow-up.2. calculate the interaction effects, if any, among the candidate components on PHQ-8 scores at immediate post-treatment, 2-week, and 8-week follow-up.3. calculate the main and interaction effects of the candidate components on measures of hopelessness, autonomy, relatedness, and competence.4. determine if the effects of the candidate components on PHQ-8 are mediated by measures of autonomy, relatedness, and competence.Additionally, the exploratory aim of this study is to determine if common factors, like credibility of the intervention and expectations to improve, can lead to symptom change., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: Participants will be randomized to one of 8 different conditions (factorial trial), following the Multiphase optimization Strategy (MOST), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants will be aware that they will be assigned to an intervention designed to help them with depressive symptoms. Participants will be aware that there are other arms of the study to which other participants are randomized, but they will not be aware of what these other arms entail. Additionally, the measures will be self-administered, so there is no scope for evaluator bias., whoMasked: PARTICIPANT, enrollmentInfo count: 880, type: ESTIMATED, armsInterventionsModule interventions name: Psychoeducation, interventions name: Testimonials and Saying is believing exercises, interventions name: Action planning, interventions name: Breathing exercise, outcomesModule primaryOutcomes measure: Patient Health Questionnaire-8, secondaryOutcomes measure: Patient Health Questionnaire-8, secondaryOutcomes measure: Beck Hopelessness Scale-4, secondaryOutcomes measure: Balanced measure of Psychological Needs scale, otherOutcomes measure: Credibility/Expectancy questionnaire, otherOutcomes measure: Intervention satisfaction star rating at post-intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False