NCT06322849

Active Elements of Digital Single-session Interventions

Factorial Trial Designed to Identify Active Elements of a Self-administered Digital Single-session Intervention Targeting Depressive Symptoms.
Northwestern University·ClinicalTrials.gov·behavioralRecruitment Completed
View on ClinicalTrials.gov
Study focus
Disease/Condition
Depression
Drug/Device/Intervention
Psychoeducation
Study type
Interventional
Intervention type
behavioral
Sponsor & location
Primary sponsor
Northwestern University
Location
Chicago, United States of America
Timeline & enrollment
Phase
N/A
Start date
May 02, 2024
End date
Jun 01, 2024
Enrollment
887 participants
Primary outcome

Patient Health Questionnaire-8

Summary

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.

ICD-10 classifications
Depressive episodeOther depressive episodesRecurrent depressive disorderRecurrent depressive disorder, unspecifiedPost-schizophrenic depression
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06322849
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06322849 through Pure Global AI's free database. This phase not specified trial is sponsored by Northwestern University and is currently Recruitment Completed. The study focuses on Depression. Target enrollment is 887 participants.

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