Testing a Digital Health Intervention App for Depression and Anxiety

NCT05373329 | Completed

• 1 other identifier: 1691460
• Study Type: interventional
• Target: 4,607
• Locations: 1 country
• Sites: 1

Brief Summary

Although mobile applications ("apps") for mental health are popular and widely available, little is known about how well they actually help people with common mental health symptoms of depression, anxiety, and stress. We are partnering with a commercially available app to test how well this app helps people's mental health over 8 weeks. Participants will be randomly assigned (like flipping a coin) to two groups: (a) using the app, (b) no app until after 8 weeks. We will ask participants to complete online surveys about their mood and well-being so we can better understand the effects of these different treatments.

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (2)

• Depression scores on the Patient Health Questionnaire-9 (PHQ-9) at end of treatment

  Participants self-reported depression symptoms. Scores range from 0 to 27 where higher scores indicate poorer outcomes (more severe depression).

  8 weeks

• Anxiety scores from the General Anxiety Disorder-7 (GAD-7) at the end of treatment

  Participants self-reported anxiety symptoms. Scores range from 0 to 21 where higher scores indicate poorer outcomes (i.e., more severe anxiety).

  8 weeks

Secondary Outcomes (1)

• Health-related quality of life scores from The Patient Reported Outcomes Measurement Information System (PROMIS) Global Health measure at the end of treatment

  8 weeks

Study Arms (2)

self-guided app use

EXPERIMENTAL

Participants receive the self-guided app intervention immediately. All participants will have a total of 8 weeks participating in the study, and will complete assessments every 2 weeks during that 8-week period.

Device: Sanvello (app)

waitlist control

NO INTERVENTION

Participants receive the self-guided intervention after an 8-week waiting period (waitlist control group). All participants will have a total of 8 weeks participating in the study, and will complete assessments every 2 weeks during that 8-week period.

Interventions

Sanvello (app) DEVICE

Sanvello is a commercially available mobile app designed to teach users strategies to manage their stress, anxiety, and depression. Users can choose which tools they want to use. The strategies are digital implementations of existing practices in psychology such as thought records, mindfulness meditation \& relaxation exercises, and behavioral activation.

Also known as: self-guided app; Sanvello Premium

self-guided app use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a compatible smartphone (Android or Apple)
• Age 18 or older
• Ability to read and write English \[Justification: (1) limited availability of Sanvello coaches fluent in languages other than English; and (2) use of English language assessments.\]
• Located in the US
• Clinically significant symptoms of depression and/or anxiety, as evidenced by:
• Scores of ≥10 on the PHQ-9 depression assessment (Kroenke et al., 2009); and/or
• Scores of ≥8 on the GAD-7 anxiety assessment (Spitzer et al., 2006)

You may not qualify if:

• Active suicidal ideation
• History of suicide attempt(s)
• Current symptoms of:
• Psychosis
• Active substance abuse
• History of provider diagnosis of:
• Bipolar disorder ("manic-depression")
• Dementia
• Intellectual disability
• Currently in or scheduled to initiate individual psychotherapy to avoid treatment interference.
• Prior use of Sanvello
• Psychotropic medication permitted if dose was stable over the past 2 weeks

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead
• Sanvello: collaborator

Study Sites (1)

University of Nevada Las Vegas

Las Vegas, Nevada, 89154, United States

Location

Related Publications (1)

• Renn BN, Walker TJ, Edds B, Roots M, Raue PJ. Naturalistic use of a digital mental health intervention for depression and anxiety: A randomized clinical trial. J Affect Disord. 2025 Jan 1;368:429-438. doi: 10.1016/j.jad.2024.09.104. Epub 2024 Sep 17.

  PMID: 39299591 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Brenna Renn, PhD

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Brenna Renn, Principal Investigator

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: May 13, 2022
• Study Start: June 14, 2021
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)