Text Messaging Program for Depression

(iDOVE2 Trial)

Not currently recruiting at 1 trial location

Overseen By Megan L Ranney, MD, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Disqualifiers: Suicidality, Psychosis, Sexual assault, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a text messaging program and a brief emergency room session in reducing depression and preventing violence among high-risk teens. Participants may receive a combination of a 20-minute motivational session in the emergency department, known as the Brief ED Intervention, and an 8-week tailored text message program designed to enhance emotional skills. Suitable candidates have experienced physical violence in the past year and exhibit mild to moderate depressive symptoms. As an unphased trial, this study provides a unique opportunity to contribute to innovative approaches for improving mental health and safety among teens.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that motivational interviewing (MI) helps people change their behavior. It is generally safe and well-tolerated. Other research supports brief cognitive behavioral therapy (CBT) as effective for mental health issues, including depression.

For text message interventions, studies have mixed results. Some people find them helpful for mental health, but their effect on depression isn't always clear. However, these text services are generally safe and do not usually cause harm.

Both the Brief ED Intervention and the Text Message Intervention are considered low-risk. They focus on education and support without using medication, reducing the chance of side effects. Overall, participants generally tolerate these interventions well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Text Messaging Program for Depression because it leverages technology to provide mental health support in a novel way. Unlike typical treatments for depression such as medication and traditional therapy, this program combines a quick, in-person session based on Motivational Interviewing and Cognitive Behavioral Therapy with a personalized, eight-week text messaging curriculum. This approach uniquely reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills through two-way communication, making mental health support more accessible and continuous. Additionally, the use of text messaging allows for real-time interaction and support, which can be particularly appealing to younger or tech-savvy populations.

What evidence suggests that this trial's treatments could be effective for depression?

Research has shown that brief cognitive-behavioral therapy (CBT) can effectively reduce symptoms of depression. Studies have found that just a few sessions of brief CBT can lead to lasting improvements, even up to a year later. In this trial, some participants will receive the Brief ED Intervention, which incorporates brief CBT techniques. The text message component, another treatment arm in this trial, has shown mixed results for depression but can help people stay committed to their therapy and feel more connected. Some studies have found text messages as effective as emails in reducing depression symptoms. Overall, both brief CBT and text messaging offer potential benefits, especially when used together, as tested in one of the trial arms. ^{3 6 7 8 9}

Who Is on the Research Team?

Megan Ranney, MD, MPH

Principal Investigator

Yale School of Public Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Reporting past-year physical violence (using a modified version of The Revised Conflict Tactics Scales (CTS-2) score ≥1), as identified on a brief screen administered in the ED

Possession of a cell phone with text-messaging capability

English-speaking

Exclusion Criteria

I am currently in the custody of police or child protective services.

I am unable to understand and agree to the study on my own.

You have reported feeling suicidal, experiencing hallucinations or delusions, being a victim of sexual assault, or being a victim of child abuse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants complete a baseline assessment and are randomized into one of four intervention groups

1 day

1 visit (in-person)

Intervention

Participants receive a 20-minute Brief ED Intervention and/or an 8-week automated text-message intervention

8 weeks

1 visit (in-person) for ED session, ongoing text messages

Follow-up

Participants are monitored for changes in depressive symptoms and peer violence at 2, 4, and 8 months post-enrollment

8 months

3 visits (virtual or in-person) at 2, 4, and 8 months

What Are the Treatments Tested in This Trial?

Interventions

• Brief ED Intervention (BI)
• Text

Trial Overview

'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.

How Is the Trial Designed?

Group I: No Brief ED Intervention (BI), + Text Experimental Treatment 1 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 Text Experimental Treatment 1 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), + Text Experimental Treatment 2 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 Text Active Control 1 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.

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

In a study of 54 participants with depression and alcohol use disorder, those receiving supportive text messages showed significantly lower depression scores after three months compared to the control group, indicating improved mood.

While the text message group also tended to have longer periods of abstinence from alcohol, the difference was not statistically significant, suggesting that supportive messaging may help but further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive text messaging for depression and comorbid alcohol use disorder: single-blind randomised trial. Agyapong, VI., Ahern, S., McLoughlin, DM., et al.[2022]

The StAR2D intervention, designed to improve diabetes treatment adherence through SMS text messages, was developed using a systematic four-phase approach that included evidence gathering, message design, stakeholder consultation, and pre-testing in Malawi and South Africa.

The intervention was informed by behavior change theories and tailored to the local context, emphasizing the importance of thorough development processes for effective public health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention development of a brief messaging intervention for a randomised controlled trial to improve diabetes treatment adherence in sub-Saharan Africa. Leon, N., Namadingo, H., Bobrow, K., et al.[2021]

A study involving 73 patients with Major Depressive Disorder found that receiving supportive text messages twice daily for 3 months significantly improved depression scores compared to a control group, with a notable effect size of 0.67.

The intervention also led to better self-rated quality of life scores, indicating that supportive text messaging could be an effective and accessible psychological intervention for depression, particularly in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled pilot trial of supportive text messages for patients with depression. Agyapong, VIO., Juhás, M., Ohinmaa, A., et al.[2018]

A study involving 855 adolescents (ages 13-17) tested a multimedia mobile phone cognitive behavioral therapy program (MEMO CBT) against a control program, but found no significant difference in depression scores after 12 months, indicating that the intervention did not effectively reduce depression symptoms.

Despite high follow-up rates (93% for MEMO CBT and 91% for control), the results suggest that universal prevention strategies for adolescent depression, like MEMO CBT, still face challenges in achieving efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MEMO: an mHealth intervention to prevent the onset of depression in adolescents: a double-blind, randomised, placebo-controlled trial. Whittaker, R., Stasiak, K., McDowell, H., et al.[2019]

The study involved 755 depressed patients and demonstrated that an automated SMS system for weekly depression monitoring was feasible and well-accepted, with a high response rate of 94.5% among participants who consented.

The SMS depression rating scale showed a moderate to high correlation with the established PHQ-9 scale and was more responsive to treatment changes, indicating its potential as a valid and sensitive tool for tracking depression in clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability and validity of SMS text messaging for measuring change in depression during a randomised controlled trial. Richmond, SJ., Keding, A., Hover, M., et al.[2018]

A pilot study of a text-messaging intervention for youths discharged from the hospital after suicidal thoughts showed it was feasible and well-received, helping to reduce suicidal thoughts and behaviors.

The positive results of this intervention led to the Maryland Department of Health expanding the program to offer similar support to all Maryland residents, highlighting its potential effectiveness in suicide prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Text-Messaging Intervention for Suicidal Youths After Emergency Department Discharge. Ryan, TC., Chambers, S., Gravey, M., et al.[2022]

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