Adaptive Messaging to Support Depression Self-Management
NCT Number: NCT06458192
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression
Interventions: BEHAVIORAL: Adaptive Messaging Intervention|BEHAVIORAL: Non-Adaptive Messaging Intervention|BEHAVIORAL: Psychoeducation-Only Control
Sponsor: Northwestern University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2026-02
Locations: Northwestern University, Chicago, Illinois, 60611, United States

Summary:
This is a pilot randomized controlled trial of an adaptive 8-week text messaging intervention for depression self-management. Among 100 individuals with elevated depression symptoms, we will compare the effects of 8 weeks of the adaptive text messaging intervention (n=40) to 8 weeks of a non-adaptive text messaging intervention (n=40), and 8 weeks of a psychoeducation-only intervention (n=20). We will include a 6-month post-treatment follow-up to verify that treatment gains are maintained.

Both messaging arms will receive 8 weeks of daily text messaging. Messages will prompt learning and applying cognitive and behavioral self-management strategies. Whereas the non-adaptive messaging system will randomly select daily messaging styles (representing a variety of self-management strategies and message tones), the adaptive messaging system will apply reinforcement learning to select daily messaging styles to maximize user engagement. Text messages will also be used to solicit feedback such as message ratings to inform the reinforcement learning algorithm (if applicable). The psychoeducation control group will receive a few brief text messages per week providing weblinks to access psychoeducation information.

We will recruit participants through digital methods (e.g., advertising on social media platforms like Facebook and Instagram).

Administration of study measures will occur at baseline, weeks 4 and 8, and 3-month and 6-month follow-up. The primary outcomes is depression symptom severity (PHQ-9). Secondary outcomes are: anxiety severity (GAD-7) and suicidality (DSI-SS). Using an Intention to Treat paradigm, we will test our hypothesis that:

H1: Relative to the psychoeducation-only control, messaging interventions will reduce depression (H1a) and anxiety and suicidal ideation (H1b).

H2: Relative to non-adaptive messaging, adaptive messaging will reduce depression (H1a) and anxiety and suicidality (H2b).

H3: Adaptive messaging will reduce depression relative to non-adaptive messaging by producing greater objective and subjective engagement.

Primary Outcome Measures: Patient Health Questionnaire (PHQ-9), PHQ-9 is a 9-item questionnaire which produces a single score between 0 and 27, with higher scores indicating greater depression symptom severity., Assessments will be completed at baseline, week 4, week 8, week 20 (3 month follow-up) and week 32 (6 month follow-up).
Secondary Outcome Measures: Generalized Anxiety Disorder (GAD-7), GAD-7 is a 7-item questionnaire screening for symptoms of generalized anxiety disorder., Assessments will be completed at baseline, week 4, week 8, week 20 (3 month follow-up) and week 32 (6 month follow-up).|Depressive Symptom Index-Suicidality Subscale (DSI-SS), DSI-SS is a brief (4-item) screening tool for suicidal symptoms., Assessments will be completed at baseline, week 4, week 8, week 20 (3 month follow-up) and week 32 (6 month follow-up).