Adaptive Messaging to Support Depression Self-Management

NCT06458192 | Completed

• 1 other identifier: STU00214828
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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, the investigators 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). The investigators 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. The investigators 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, the investigators 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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Generalized Anxiety Disorder (GAD-7)

  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)

  Assessments will be completed at baseline, week 4, week 8, week 20 (3 month follow-up) and week 32 (6 month follow-up).

Study Arms (3)

Adaptive Messaging Intervention

EXPERIMENTAL

The intervention involves 8 weeks of daily text messaging. Messages will arrive throughout the day via SMS to prompt learning and applying cognitive and behavioral self-management strategies, representing a variety of self-management strategies and message tones. The intervention will apply reinforcement learning to select daily messaging styles to maximize user engagement.

Behavioral: Adaptive Messaging Intervention

Non-Adaptive Messaging Intervention

EXPERIMENTAL

The intervention involves 8 weeks of daily text messaging. Messages will arrive throughout the day via SMS to prompt learning and applying cognitive and behavioral self-management strategies, representing a variety of self-management strategies and message tones. Daily messaging styles will be randomly selected.

Behavioral: Non-Adaptive Messaging Intervention

Psychoeducation-only control

ACTIVE COMPARATOR

The 8-week intervention involves receiving several text messages per week that include weblinks to access psychoeducation information about cognitive and behavioral self-management strategies.

Behavioral: Psychoeducation-Only Control

Interventions

Adaptive Messaging Intervention BEHAVIORAL

The intervention delivers 8 weeks of daily text messaging. Messages will arrive throughout the day via SMS to prompt learning and applying cognitive and behavioral self-management strategies, representing a variety of self-management strategies and message tones. The intervention will apply reinforcement learning to select daily messaging styles to maximize user engagement.

Also known as: Small Steps SMS

Adaptive Messaging Intervention

Non-Adaptive Messaging Intervention BEHAVIORAL

The intervention involves 8 weeks of daily text messaging. Messages will arrive throughout the day via SMS to prompt learning and applying cognitive and behavioral self-management strategies, representing a variety of self-management strategies and message tones. Daily messaging styles will be randomly selected.

Also known as: Small Steps SMS

Non-Adaptive Messaging Intervention

Psychoeducation-Only Control BEHAVIORAL

An active control which will deliver psychoeducational content via clickable URLs over 8 weeks.

Psychoeducation-only control

Eligibility Criteria

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

You may qualify if:

• + years of age
• At least moderate depressive symptom severity (a score of 10 or higher on the PHQ-8)
• Has a smartphone
• Is able to speak and read English
• US citizen or resident

You may not qualify if:

• Reports diagnosis with a severe mental health problem (e.g., psychotic, bipolar) for which participation in this trial is inappropriate
• High suicide risk (has ideation, plan, and intent)
• Is currently receiving psychotherapy or intends to commence it in the next 8 weeks
• Psychiatric medication dose change in the past 4 weeks, or has plans to change the dose of a psychiatric medication

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60622, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 9, 2024
• First Posted: June 13, 2024
• Study Start: January 13, 2025
• Primary Completion: December 11, 2025
• Study Completion: December 11, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)