Anxiety Disorders, Depression
Conditions
Keywords
Mobile app, Engagement, Depression, Anxiety, Micro-randomized trial
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSilverCloud
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.
Sponsors
Brigham and Women's Hospital
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
2x2 factorial trial with micro-randomization in automated motivational messaging arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to disengagement | 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 |
| Intervention Engagement Within 3 Hours Following a Decision Point - Proximal (Short-Term) | 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
| Measure | Time frame | Description |
|---|---|---|
| Minutes of Intervention Use - Distal (Long-Term) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJessica M Lipschitz, PhD
Brigham and Women's Hospital
Outcome results
None listed