REACHOUT Mental Health Support Mobile App

University of British Columbia

Status: Active, not recruiting

Conditions: Type1diabetes

Treatments: Behavioral: REACHOUT Virtual Mental Health Support

Study type: Interventional

Funder types: Other

Identifiers

NCT05668507

H22-02196

Details and patient eligibility

About

The purpose of this study is to investigate the effectiveness of participation in a 6-month peer-led mental health support program, delivered via a mobile app (REACHOUT), to adults with type 1 diabetes compared to a wait-list control condition. Participants will connect with a Peer-Supporter (an adult with type 1 diabetes trained in providing mental health support), and have access to the app features including a 24/7 chat room and face-to-face support delivered via virtual happy hours.

Full description

REACHOUT is a mobile app which delivers peer-led mental health support to adults with type 1 diabetes. The mobile app has three support features:

1. One-on-one support delivered by a Peer Supporter

   Peer Supporters are adults with type 1 diabetes who will be trained on providing support to other adults with type 1 diabetes on the app ("the participants"). Participants will be able to go through the peer supporter library, review their profiles, and choose their peer supporter.

2. Group support delivered via a 24/7 chat room

   Peer Supporters and participants on the app will be able to chat 24/7 in the chat room about any topic ranging from feedback on new devices to traveling with diabetes. The chat room is monitored by healthcare professionals including a registered nurse and registered psychologist.

3. Face to face support delivered via virtual happy hours

Virtual happy hours are educational presentations/discussions led by either a Peer Supporter or healthcare professional on topics related to diabetes.

Participants will be randomly assigned to the intervention group or the wait-list control group. The intervention group will be given access to the mobile app right away and the wait-list control group will be given access to the mobile app after six months.

The intervention is 6 months long. All participants and Peer Supporters will go through an assessment at the start and end of the program. The assessment includes a blood draw to measure hemoglobin A1c, and questionnaires measuring diabetes distress, perceived social support, depressive symptoms, resilience, quality of life, and costs related to diabetes. There will also be questionnaires throughout the program including at 1-month and 3-months. Participants and Peer Supporters who own a Dexcom G6 continuous glucose monitor (CGM) will be asked if they would like to share their CGM data.

Enrollment: 225 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• have type 1 diabetes (T1D)
• be 19 years or older
• reside in one of the targeted health authorities in British Columbia (Fraser Health, Island Health, Northern Health, and Interior Health Authorities)
• be English proficient
• have an average diabetes distress (DD) Subscale Score ≥ 2
• have access to the internet and/or a smartphone.

Exclusion criteria

• Participants with a pre-existing mental health condition, multiple co-morbidities, substance use challenges, and or any other condition that may prevent meaningful participation may not participate in this study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

225 participants in 2 patient groups

REACHOUT

Experimental group

Description:

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.

Treatment:

Behavioral: REACHOUT Virtual Mental Health Support

Wait-list

No Intervention group

Description:

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.