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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 887 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Psychoeducation	Psychoeducation is a potential active element of Project ABC. In psychoeducation, participants learn about the cognitive model of behavior and how they can take action to change their moods.
BEHAVIORAL	Testimonials and Saying is believing exercises	Testimonials and Saying is believing exercises is a potential active element of Project ABC. In this element, participants learn about how others have taken action to improve their mood and complete one exercise where they give advice to a virtual peer who is stuck in a negative spiral.
BEHAVIORAL	Action planning	Action planning is a potential active element of Project ABC. In this element, participants plan in detail an action they can take to get out of the negative mood spiral.
BEHAVIORAL	Breathing exercise	Participants will be presented with a one-minute breathing exercise.

Timeline

• Start date: 2024-05-02
• Primary completion: 2024-07-18
• Completion: 2024-07-18
• First posted: 2024-03-21
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States