Jessica Morrow Lipschitz
Boston, Massachusetts, 02115-5804, United States
NCT Number: NCT05555875
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115-5804, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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.
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.
Brigham and Women's Hospital
Other
A Clinical Trial Aimed at Evaluating Factors Contributing to Patient Engagement With Digital Mental Health Interventions
Acronym: jq830
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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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