What prior FDA approvals exist?

The REACHOUT Peer-Led Mental Health Support Program focuses on peer support and virtual interaction to improve mental health in adults with Type 1 Diabetes. While the provided context does not detail specific FDA approvals for treatments combining peer support and virtual interaction, it is known that traditional FDA-approved treatments for Type 1 Diabetes primarily include insulin therapy and continuous glucose monitoring systems. These treatments aim to manage blood glucose levels effectively. The REACHOUT program represents an innovative approach by integrating mental health support with diabetes management, addressing the psychological aspects of living with Type 1 Diabetes.

What other types of research exist?

Promising alternatives to the REACHOUT Peer-Led Mental Health Support Program for Type 1 Diabetes patients include: 1) Internet-based cognitive-behavioral therapy (CBT) programs, which have shown efficacy in improving mental health outcomes. 2) Mobile apps offering structured CBT and mindfulness exercises, such as those designed for smoking cessation but adaptable for mental health support. 3) Telehealth services providing remote access to mental health professionals for personalized therapy sessions. 4) Social network-based interventions, like those using platforms such as Facebook or Twitter, to create supportive communities and deliver mental health resources.

← Back to Search

Behavioral Intervention

REACHOUT Mental Health Support App for Type 1 Diabetes

N/A

Waitlist Available

Led By Tricia S Tang, PhD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

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

Must have

Have type 1 diabetes (T1D)

Be 19 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 3, 6 month(s)

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates the effectiveness of the REACHOUT app, which offers mental health support to adults with type 1 diabetes through peer interactions and virtual meetings. The app includes personalized peer support, a 24/7 chat room, and virtual educational sessions. It aims to provide emotional and practical help to those managing type 1 diabetes.

Who is the study for?

This trial is for adults over 19 with type 1 diabetes who live in certain areas of British Columbia, speak English, and experience some distress related to their diabetes. They must have internet or smartphone access. Those with pre-existing mental health conditions or substance use issues cannot participate.

What is being tested?

The study tests a mobile app called REACHOUT that offers peer-led mental health support to adults with type 1 diabetes. Participants will use the app's features like chat rooms and virtual happy hours for six months, compared to a wait-list group.

What are the potential side effects?

Since this trial involves a support program rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort or privacy concerns while using the app.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have type 1 diabetes.

Select...

I am 19 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 3, 6 month(s)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 3, 6 month(s)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 3, 6 month(s) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Diabetes Distress

Secondary study objectives

Change in % Time in Range

Change in Depressive Symptom Severity

Change in Diabetes-Specific Quality of Life

+6 more

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

Active Control

Group I: REACHOUTExperimental Treatment1 Intervention

The REACHOUT intervention arm will receive access to the REACHOUT mobile app through which they will be able to review profiles of Peer Supporters and connect with one of their choosing. They will also have access to the other app features including a 24/7 chat room and face-to-face support via virtual happy hours. Participants will complete questionnaires (baseline, 1 month, 3 months, 6 months) and a blood draw (baseline and 6 months). Monetary compensation will be provided for their time and effort.

Group II: Wait-listActive Control1 Intervention

The wait-list control group will receive access to the mobile app/support program after six (6) months. They will complete questionnaires and a blood draw at baseline and 6 months. Monetary compensation will be provided for their time and effort.

0 / 2Eligibility criteria met

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

The primary treatment for Type 1 Diabetes is insulin therapy, which involves administering insulin to regulate blood glucose levels, as patients with Type 1 Diabetes cannot produce insulin on their own. This is crucial for preventing complications such as ketoacidosis and long-term damage to organs. Additionally, mental health support, such as the REACHOUT Peer-Led Mental Health Support Program, plays a significant role. This program uses peer support and virtual interactions to help patients manage diabetes-related distress, improve adherence to treatment, and enhance overall quality of life. Combining medical and psychological support addresses both the physical and emotional challenges of living with Type 1 Diabetes.

Efficacy of eHealth Interventions for Adults with Diabetes: A Systematic Review and Meta-Analysis.ACTonDiabetes-a guided psychological internet intervention based on Acceptance and Commitment Therapy (ACT) for adults living with type 1 or 2 diabetes: results of a randomised controlled feasibility trial.Web-Based Interventions for Depression in Individuals with Diabetes: Review and Discussion.