What side effects are associated with this type of intervention?

Psychosocial treatments for depression, such as cognitive-behavioral therapy (CBT) and other behavioral interventions, generally have minimal physical side effects. However, they can sometimes lead to emotional discomfort as patients confront difficult thoughts and feelings. Common pharmacological treatments for depression, such as selective serotonin reuptake inhibitors (SSRIs) and other antidepressants, can have side effects including nausea, weight gain, sexual dysfunction, insomnia, dry mouth, and increased anxiety. It is important to discuss potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

FDA-approved treatments for depression primarily include pharmacotherapy with medications such as SSRIs (e.g., fluoxetine, sertraline), SNRIs (e.g., venlafaxine, duloxetine), and tricyclic antidepressants (e.g., imipramine). These medications have demonstrated efficacy in reducing depressive symptoms. Psychotherapies like cognitive-behavioral therapy (CBT) and interpersonal psychotherapy (IPT) are also commonly used, especially for treatment-resistant cases. The iDOVE2 trial's approach, involving a brief emergency department session and automated text messages, represents a novel intervention not yet reflected in traditional FDA approvals.

What other types of research exist?

Promising alternatives to iDOVE2 for treating depression in 2024 include: 1) Mobile phone-based interventions, such as smartphone apps that provide real-time monitoring and notifications to reduce depressive symptoms. 2) Internet-based cognitive behavioral therapy (CBT) programs, which have been shown to be effective in multiple studies. 3) Telemedicine platforms offering remote therapy sessions, which can increase access to mental health care. 4) Ecological momentary assessment (EMA) techniques using smartphones to provide real-time feedback and support. 5) Group behavior therapy programs conducted online, which can offer peer support and structured therapy sessions.

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Text Messaging Program for Depression (iDOVE2 Trial)

N/A

Recruiting

Led By Megan L Ranney, MD MPH

Research Sponsored by Rhode Island Hospital

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 12 months before enrollment and 12 months after enrollment

Awards & highlights

Summary

This trial tests a program that starts with a session in the emergency room and continues with automated text messages to help high-risk teens prevent depression and violence. The program targets teens who often use emergency services and may lack other mental health resources. It provides ongoing support through text messages, with additional live counseling if no improvement is seen.

Who is the study for?

This trial is for English-speaking adolescents who have experienced physical violence in the past year and are showing mild-to-moderate depressive symptoms. They must be getting routine care in an emergency department, have a parent or guardian present to consent, and own a cell phone that can send texts.

What is being tested?

'iDOVE2' is being tested to prevent peer violence and depression among at-risk youth. It includes an initial brief session in the emergency department followed by ongoing automated text messages designed to support mental health over time.

What are the potential side effects?

Since 'iDOVE2' involves non-medical interventions like educational sessions and text messaging, traditional side effects associated with medications are not expected. However, there may be emotional or psychological impacts from discussing sensitive topics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months before enrollment and 12 months after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months before enrollment and 12 months after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months before enrollment and 12 months after enrollment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Center for Epidemiologic Studies Depression Scale Revised (CESD-R)

Conflict Tactics Scale-2, physical subset (CTS-2)

Secondary study objectives

Change in ED Visits for Assault-Related Injury

Conflict in Adolescent Dating Relationships Inventory, physical subset (CADRI)

Illinois Bully Scale (IBS)

+1 more

Other study objectives

Bosworth Violence Self-Efficacy Scale

Emotional Regulation Questionnaire for Children and Adolescents (ERQ-CA)

Self-Efficacy Questionnaire for Children (SEQ-C)

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: No Brief ED Intervention (BI), + TextExperimental Treatment1 Intervention

Participants receive the Text Message Intervention component only (8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills). Participants receive a brochure containing online and community resources for violence and depression prevention instead of the Brief ED Intervention component.

Group II: + Brief ED Intervention (BI), no TextExperimental Treatment1 Intervention

Participants receive the Brief ED Intervention component only (which is a 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant).

Group III: + Brief ED Intervention (BI), + TextExperimental Treatment2 Interventions

Participants receive both the Brief ED Intervention component (a 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant) and the Text Message Intervention component (8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills).

Group IV: No Brief ED Intervention (BI), no TextActive Control1 Intervention

Participants receive neither the Brief ED Intervention component, nor the Text Message Intervention component. Participants receive a brochure containing online and community resources for violence and depression prevention, instead of the Brief ED Intervention component.

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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 include cognitive-behavioral therapy (CBT), exercise, pharmacotherapy, and technology-supported interventions like those in the iDOVE2 trial. CBT works by addressing distorted cognitions and improving emotional and social functioning, which helps patients develop healthier thought patterns and behaviors. Exercise is believed to improve mood through the release of endorphins and other neurochemical changes. Pharmacotherapy, involving antidepressants, aims to correct chemical imbalances in the brain. Technology-supported interventions, such as automated text-message programs, provide continuous support and reminders, helping patients adhere to treatment plans and feel less isolated. These mechanisms are crucial as they offer diverse ways to manage depression, catering to individual needs and improving overall treatment adherence and outcomes.

Interventions to prevent suicidal behavior and ideation for patients with cancer: A systematic review.Toward the Design of Evidence-Based Mental Health Information Systems for People With Depression: A Systematic Literature Review and Meta-Analysis.Evidence-based, non-pharmacological treatment guideline for depression in Korea.

Find a Location

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor

262 Previous Clinical Trials

68,139 Total Patients Enrolled

9 Trials studying Depression

1,598 Patients Enrolled for Depression

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

2,014 Previous Clinical Trials

2,696,034 Total Patients Enrolled

32 Trials studying Depression

14,688 Patients Enrolled for Depression

Megan L Ranney, MD MPHPrincipal InvestigatorYale School of Public Health

1 Previous Clinical Trials

77 Total Patients Enrolled

~41 spots leftby Feb 2025

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