Text Messaging Program for Depression

(iDOVE2 Trial)

Recruiting at 1 trial location

Overseen By Dimitri Luzincourt, MA

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

800 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Brief ED Intervention (BI), Text for depression?

Research shows that text messaging programs can help reduce depressive symptoms and are feasible and acceptable for patients. Similar interventions have been effective in supporting patients with depression and other conditions like alcohol use disorder, and in reducing suicidal thoughts among youths. ^{1 2 3 4 5}

Is the text messaging program for depression safe for humans?

The research suggests that using text messaging for depression is generally safe, as it is a private and scalable way to screen and monitor depression without significant safety concerns reported in the studies. ^{2 6 7 8 9}

How is the Text Messaging Program for Depression treatment different from other treatments for depression?

The Text Messaging Program for Depression is unique because it uses mobile phone text messages to provide support and monitor depression, making it accessible and affordable, especially for low-income individuals who face barriers like transportation and childcare. This approach is different from traditional in-person therapy or medication, as it leverages technology to reach patients in a scalable and private manner. ^{2 4 6 10 11}

Research Team

Megan Ranney, MD, MPH

Principal Investigator

Yale School of Public Health

Eligibility Criteria

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

Possession of a cell phone with text-messaging capability

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A technology-augmented intervention to prevent peer violence and depressive symptoms among at-risk emergency department adolescents: Protocol for a randomized control trial. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Supportive text messaging for depression and comorbid alcohol use disorder: single-blind randomised trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A Brief Text-Messaging Intervention for Suicidal Youths After Emergency Department Discharge. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Randomized controlled pilot trial of supportive text messages for patients with depression. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

A text message alcohol intervention for young adult emergency department patients: a randomized clinical trial. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Screening Depression and Related Conditions via Text Messaging Versus Interview Assessment: Protocol for a Randomized Study. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Engaging users in the design of an mHealth, text message-based intervention to increase physical activity at a safety-net health care system. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Using High-Risk Adolescents' Voices to Develop a Comprehensible Cognitive Behavioral Therapy-Based Text-Message Program. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability and validity of SMS text messaging for measuring change in depression during a randomised controlled trial. [2018]

10. England pubmed.ncbi.nlm.nih.gov

MEMO: an mHealth intervention to prevent the onset of depression in adolescents: a double-blind, randomised, placebo-controlled trial. [2019]

11. England 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. [2021]