Active Elements of Digital Single-session Interventions

Northwestern University

Status: Completed

Conditions: Depression

Treatments: Behavioral: Action planning; Behavioral: Breathing exercise; Behavioral: Testimonials and Saying is believing exercises; Behavioral: Psychoeducation

Study type: Interventional

Funder types: Other

Identifiers

NCT06322849

STU00220591

Details and patient eligibility

About

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.

Enrollment: 887 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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887 participants in 8 patient groups

Arm 1

Experimental group

Description:

Experimental: Breathing exercise + active elements 1, 2, 3 In this arm, all three factors are set to active (i.e. yes): * Psychoeducation * Testimonials and Saying is believing exercises * Action planning

Treatment:

Behavioral: Psychoeducation

Behavioral: Testimonials and Saying is believing exercises

Behavioral: Breathing exercise

Behavioral: Action planning

Arm 2

Experimental group

Description:

Experimental: Breathing exercise + active elements 1, 2 In this arm, two factors are set to active (i.e. yes): * Psychoeducation * Testimonials and Saying is believing exercises

Treatment:

Behavioral: Psychoeducation

Behavioral: Testimonials and Saying is believing exercises

Behavioral: Breathing exercise

Arm 3

Experimental group

Description:

Experimental: Breathing exercise + active elements 1, 3 In this arm, two factors are set to active (i.e. yes): * Psychoeducation * Action planning

Treatment:

Behavioral: Psychoeducation

Behavioral: Breathing exercise

Behavioral: Action planning

Arm 4

Experimental group

Description:

Experimental: Breathing exercise + active elements 2, 3 In this arm, two factors are set to active (i.e. yes): * Testimonials and Saying is believing exercises * Action planning

Treatment:

Behavioral: Testimonials and Saying is believing exercises

Behavioral: Breathing exercise

Arm 5

Experimental group

Description:

Experimental: Breathing exercise + active element 1 In this arm, one factor is set to active (i.e. yes): • Psychoeducation

Treatment:

Behavioral: Psychoeducation

Behavioral: Breathing exercise

Arm 6

Experimental group

Description:

Experimental: Breathing exercise + active element 2 In this arm, one factor is set to active (i.e. yes): • Testimonials and Saying is believing exercises

Treatment:

Behavioral: Testimonials and Saying is believing exercises

Behavioral: Breathing exercise

Arm 7

Experimental group

Description:

Experimental: Breathing exercise + active element 3 In this arm, one factor is set to active (i.e. yes): • Action planning

Treatment:

Behavioral: Breathing exercise

Behavioral: Action planning

Arm 8

Experimental group

Description:

Experimental: Breathing exercise only In this arm, none of the three factors are set to active (i.e. yes)

Treatment:

Behavioral: Breathing exercise