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OpenTrials
Completed

NCT Number: NCT05555875

Toward Understanding Drivers of Patient Engagement With Digital Mental Health Interventions - Part II

This study is a clinical trial that evaluates what drives patient engagement and tests the impact of two strategies-automated motivational push messaging and coach support-to improve engagement with an evidence-based mobile app intervention for depression and/or anxiety.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessica Morrow Lipschitz

Boston, Massachusetts, 02115-5804, United States

About this study

This 8-week, clinical trial involves primary care patients with clinically significant depression and/or anxiety recruited via provider referral. Participants will received access to a digital mental health intervention with known efficacy and be randomized to an engagement strategy condition--a previously-validated Coach Support protocol (CS), a newly-developed automated motivational messaging protocol (AMM), both or neither. To further understand how messages in the AMM arms function, message delivery will be micro-randomized: each day participants will be randomized to receive a message or not, such that they receive an average of 4.2 messages/week. Micro-randomization allows causal inference about the near-term impact of message delivery (i.e., are AMMs a cue to action) and the relationship between message impact and context (e.g., day in study). Measured outcome data will include level of engagement (operationalized as time to disengagement and minutes of use) and weekly self-reports of clinical outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mass General Brigham primary care patient
  • Age 18+
  • Clinically significant symptoms of depression (Patient Health Questionnaire-9 (PHQ-9) greater than or equal to 10) and/or anxiety (Generalized Anxiety Disorder-7 (GAD-7) greater than or equal to 8)
  • Owns a smartphone capable of running the study applications
  • Fluent in English.

Exclusion criteria

  • Diagnosis of bipolar I or bipolar II disorder per patient report or the patient's medical record
  • Diagnosis of any psychotic disorder per patient report or the patient's medical record
  • Current substance use disorder per patient report or the patient's medical record
  • Acute and/or unstable medical problem that may interfere with participation (e.g., scheduled for surgery in the next two months).

Treatment and study plan

SilverCloud

Behavioral

Digital mental health intervention for individuals struggling with depression and/or anxiety. The intervention reflects components of evidence-based psychological treatments such as cognitive-behavioral therapy.

Primary outcomes

  1. Time to disengagement

    Time frame: 8-week intervention period

    disengagement from the digital mental health intervention is defined as the first week of <1 minute of use after which there are no subsequent weeks with at least 1 minute of use

  2. Intervention Engagement Within 3 Hours Following a Decision Point - Proximal (Short-Term)

    Time frame: For 3 hours after each decision point, over the 8-week intervention period

    Intervention use logs will be collected continuously and automatically throughout the intervention period on the system backend. Proximal Intervention engagement will be operationalized as whether or not the intervention was used within 3 hours of a decision point (i.e., the point at which participants in the automated motivational messaging arms were randomized to receive or not receive an automated motivational message). This outcome only applies to participants randomized to receive automated motivational messaging.

Secondary outcomes

  1. Minutes of Intervention Use - Distal (Long-Term)

    Time frame: 8-week intervention period

    Intervention use logs will be collected continuously and automatically throughout the intervention period on the system backend. Intervention engagement will be operationalized as minutes of active use over the intervention period.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

A Clinical Trial Aimed at Evaluating Factors Contributing to Patient Engagement With Digital Mental Health Interventions

Acronym: jq830

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 27, 2022
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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