Testing Scalable, Single-Session Interventions for Adolescent Depression in the Context of COVID-19

Stony Brook University

Status: Completed

Conditions: Depression

Treatments: Behavioral: Behavioral Activation SSI; Behavioral: Growth Mindset SSI; Behavioral: Supportive Therapy SSI

Study type: Interventional

Funder types: Other

Identifiers

NCT04634903

1505797-3

Details and patient eligibility

About

Most mental health problems emerge by age 14, often leading to chronic impairments and adverse impacts for individuals, families, and societies. Any action-focused path to reducing the need-to-access gap will require moving beyond the dominant settings, formats, and systems that have constrained intervention delivery to date. In a fully-online trial, youths ages 13-16 will be randomized to 1 of 3 self-administered single-session interventions (SSIs): a behavioral activation SSI, targeting behavioral MD symptoms; an SSI teaching growth mindset, targeting cognitive MD symptoms; or a control SSI. The investigators will test each SSI's relative benefits, versus the control, on depressive symptoms and proximal outcomes such as hopelessness. Results will reveal whether SSIs that were designed to address behavioral versus cognitive symptoms differentially benefit adolescents with elevated depressive symptoms.

Enrollment: 2,452 patients

Sex: All

Ages: 13 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• are fluent in English
• have consistent internet and computer/laptop/smartphone access
• report elevated depressive symptoms (a score of >2 on the Patient Health Questionnaire-2 item version [PHQ-2])

Exclusion criteria

• fail to meet the above-listed inclusion criteria
• exit the study prior to condition randomization
• respond with either copy/pasted responses from text earlier in the intervention to any of free response questions
• obvious lack of English fluency in open response questions
• responding with random text in open response questions
• duplicate responses from the same individual in baseline or follow-up surveys

We will also exclude for primary analyses (but may run sensitivity analyses including them) any participants who provide responses of fewer than 3 words to writing prompts that ask for at least 2 sentences or more.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,452 participants in 3 patient groups

Supportive Therapy SSI (ST-SSI)

Active Comparator group

Description:

The web-based supportive therapy (ST-SSI) intervention, called the Sharing Feelings Intervention, is designed to mimic supportive therapy (ST). The goals of the ST intervention are to encourage participants to identify and express feelings to close others; the intervention does not teach or emphasize specific skills or beliefs. In previous clinical trials, ST has resulted in significantly fewer reductions in youth internalizing problems compared to cognitive-behavioral and growth mindset interventions. The ST-SSI is designed to control for nonspecific aspects of intervention, including engagement in a computer program. It includes the same number of reading and writing activities as the other SSIs.

Treatment:

Behavioral: Supportive Therapy SSI

Behavioral Activation SSI (BA-SSI)

Experimental group

Description:

The BA-SSI include 5 elements: (1) An introduction to the program's rationale: that engaging in value-based activities can combat sad mood and low self-esteem; (2) Psychoeducation about depression, including how behavior shapes feelings and thoughts; (3) A life values assessment, where youth identify key areas from which they draw enjoyment and meaning; (4) Creation of an activity hierarchy, where youth identify and personalize (in guided exercises) 3 activities to target for change; and (5) An exercise in which youths write about benefits that might result from engaging in each activity; an obstacle that might keep them from doing the activities; and a strategy for overcoming identified obstacles.

Treatment:

Behavioral: Behavioral Activation SSI

Growth Mindset SSI (GM-SSI)

Experimental group

Description:

Program includes: An introduction to the brain and a lesson on neuroplasticity; Testimonials from older youths who describe their views that traits are malleable Further stories by older youths, describing times when they used "growth mindsets" to persevere during social/emotional setbacks; Study summaries noting how/why personality can change; And an exercise in which youths write notes to younger students, using scientific information to explain people's capacity for change.

Treatment:

Behavioral: Growth Mindset SSI