What side effects are associated with this type of intervention?

Common treatments for depression include pharmacological options like SSRIs and SNRIs, which can cause side effects such as nausea, weight gain, sexual dysfunction, insomnia, and increased anxiety. Psychotherapeutic interventions like CBT and MBCT generally have fewer physical side effects but may lead to temporary emotional discomfort. Digital single-session interventions focusing on behavioral modification are likely to have minimal side effects, primarily involving temporary emotional discomfort or frustration.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for depression, including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and citalopram, and serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine. These medications are often used in combination with cognitive behavioral therapy (CBT) to enhance treatment efficacy. While digital or single-session behavioral interventions like the one studied in the Single-Session Digital Intervention trial are promising, they have not yet been specifically mentioned in the context of FDA approvals for depression treatment.

What other types of research exist?

Promising alternatives to Single-Session Digital Intervention for depression patients include: 1) Blended therapy combining Cognitive Behavioral Analysis System of Psychotherapy (CBASP) with app-based interventions like CBASPath, which has shown feasibility and potential for high adherence and patient self-management. 2) Internet-based guided self-help CBT, which has demonstrated efficacy in reducing symptoms of depression through structured online modules and therapist support. 3) Smartphone applications for self-monitoring and behavioral interventions, which have been effective in managing various mental health conditions, including depression.

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Digital Single Session Intervention for Youth Mental Health

N/A

Recruiting

Led By Katherine Venturo-Conerly, A.B.

Research Sponsored by Harvard University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an online program for kids aged 9-17 who are waiting for mental health treatment. The program teaches them to change negative behaviors by practicing positive ones, helping them feel better while they wait for therapy.

Who is the study for?

This trial is for English-speaking youths aged 9-17 in the Boston area who are on a waitlist for mental health care. They must have access to a digital device, be able to read English well enough to complete digital programs, and have consent from at least one guardian.

What is being tested?

The study tests 'Practicing the Opposite' (PTO), a single-session digital intervention aimed at improving youth mental health against usual waitlist procedures. It's designed for those awaiting psychotherapy.

What are the potential side effects?

Since this is a psychological educational intervention, traditional physical side effects are not applicable. However, participants may experience emotional discomfort or distress as they engage with the material.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up.

This trial's timeline: 3 weeks for screening, Varies for treatment, and trajectory of change in scores compared across intervention and control groups from baseline, through post-intervention, 2-week, and 1-month follow-up. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Behavior and Feelings Survey (Youth and Parent Versions)

Generalized Anxiety Disorder 7-item scale (GAD-7)

Patient Health Questionnaire 8-item scale (PHQ-8)

+1 more

Secondary study objectives

Clinic Record Data

Ecological Momentary Assessment (EMA) Survey

Perceived Control Scale for Children

+2 more

Other study objectives

Demographic Questionnaire

Feedback Questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Usual waitlist control groupExperimental Treatment1 Intervention

Usual waitlist procedures involve watchful waiting for a therapist to become available, sometimes complemented by periodic check-ins from the family with clinic administrators. After being removed from the waitlist and contacted to begin treatment, participants in both study conditions will receive treatment as usual in the clinic.

Group II: Practicing the Opposite (PTO) interventionExperimental Treatment1 Intervention

This 30-45 minutes Qualtrics-based, digital program uses stories, interactive activities, and engaging graphics to teach youths one core principle: by practicing the positive opposite of unhelpful behaviors (e.g., engaging with rather than avoiding feared stimuli), one can, over time, change their mood, thoughts, and actions. The intervention is comprised of four main sections: 1) An introduction to PTO; (2) Testimonials from young people who have been helped by PTO; (3) Learning how to Practice the Opposite through online activities. (4) Planning how to continue to Practice the Opposite in the participant's life. Of note, after being removed from the waitlist at the clinic and contacted to begin treatment, participants will still receive treatment as usual from the clinic.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression, such as cognitive-behavioral therapy (CBT), mindfulness-based cognitive therapy (MBCT), and pharmacotherapy, work through different mechanisms. CBT focuses on identifying and changing negative thought patterns and behaviors, helping patients develop healthier coping strategies. MBCT combines mindfulness practices with cognitive therapy to help patients become more aware of their thoughts and feelings, reducing the risk of relapse. Pharmacotherapy, typically involving antidepressants, works by altering brain chemistry to improve mood and emotional regulation. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options and manage their expectations regarding the outcomes and potential side effects.

Brief psychotherapy: current status.Delineating mechanisms of change in child and adolescent therapy: methodological issues and research recommendations.