Factorial Trial Designed to Identify Active Elements of a Self-administered Digital Single-session Intervention Targeting Depressive Symptoms.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Northwestern University
- Enrollment
- 887
- Locations
- 1
- Primary Endpoint
- Patient Health Questionnaire-8
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief 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:
- 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.
- 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.
- calculate the main and interaction effects of the candidate components on measures of hopelessness, autonomy, relatedness, and competence.
- 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.
Investigators
Jessica Schleider
Associate Professor, Northwestern University
Northwestern University
Eligibility Criteria
Inclusion Criteria
- •Located in the United States
- •Baseline Patient Health Questionnaire-8 (PHQ-8) score \>= 10
- •Able to read and write English
- •Able to access to the internet via a computer, tablet or smartphone for the next eight weeks
Exclusion Criteria
- •Participants who have participated in another related study on depression from our laboratory via the same participant recruitment platform in the past two months
- •Participants who have submitted gibberish in open response questions
Outcomes
Primary Outcomes
Patient Health Questionnaire-8
Time Frame: Baseline to 8-week post-intervention
Patient Health Questionnaire-8 is a well-validated and self-administered measure to assess depression symptom severity in the general population. Participants are asked to rate how often they are bothered by 8 items (e.g., Poor appetite or overeating) on a scale of 0 (Not at all) to 3 (Nearly every day). Total score can range from 0 to 24, with higher scores indicating higher symptom severity.
Secondary Outcomes
- Balanced measure of Psychological Needs scale(Baseline to immediate post-intervention; Baseline to 2-week post-intervention; Baseline to 8-week post-intervention)
- Beck Hopelessness Scale-4(Baseline to immediate post-intervention; Baseline to 2-week post-intervention; Baseline to 8-week post-intervention)
- Patient Health Questionnaire-8(Baseline to 2-week post-intervention)