Active Elements of Digital Single-session Interventions
NCT06322849 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 887
Last updated 2024-09-19
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
Interventions
- 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.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Jessica L Schleider · Northwestern University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-02
- Primary Completion
- 2024-07-18
- Completion
- 2024-07-18
Countries
- United States
Study Locations
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