Adaptive Messaging to Support Depression Self-Management

Depression Clinical Trial

Official title:

Adaptive Messaging to Support Depression Self-Management

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458192
• Other study ID #: STU00214828
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: February 2026

Study information

• Verified date: June 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The primary goal of this prospective randomized controlled trial is to pilot all trial procedures for a larger, fully-powered trail. We will enroll 100 participants out of consideration for feasibility.

Among individuals with elevated depression symptoms, we will compare the effects of 8 weeks of an adaptive text messaging intervention (n=40), 8 weeks of a non-adaptive text messaging intervention (n=40), and a psychoeducation-only control group (n=20). We will include a 6-month post-treatment follow-up to verify that treatment gains are maintained.

The study will enroll individuals who have at least moderate symptoms of depression as indicated by Patient Health Questionnaire-9 (PHQ-9) scores greater than or equal to 10.

We will recruit participants through digital methods (e.g., advertising on social media platforms like Facebook and Instagram). Recruitment advertisements will direct potential participants to a centralized recruitment website that provides additional information about the IRB-approved protocol. Participants will represent likely users of a mobile-based depression intervention. They will also reflect the racial and ethnic diversity of the United States. Interested individuals will confirm eligibility by completing an online screening survey. Participants will self-report their specific recruitment source as part of this survey and will provide contact information. If eligible participants confirm interest, study staff will obtain informed consent.

Computer-generated randomization will be created prior to the start of the study to avoid allocation bias. Random block sizes of 5 and 10 will be allocated in a 2:2:1 ratio to adaptive messaging, non-adaptive messaging, and the psychoeducation-only control group.

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.

Administration of study measures will occur as part of the research protocol via REDCap online 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). We will additionally assess subjective and objective engagement with the intervention (messaging arms only).

We will collect qualitative data with a subset of 10 participants in each messaging arm via user interviews.

Using an Intention to Treat paradigm, we will use longitudinal linear mixed-effects models to 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

(1) 18+ years of age; (2) At least moderate depressive symptom severity (a score of 10 or higher on the PHQ-8); (3) Has a smartphone; (4) Is able to speak and read English; (5) US citizen or resident

Exclusion Criteria:

(1) Reports diagnosis with a severe mental health problem (e.g., psychotic, bipolar) for which participation in this trial is inappropriate; (2) High suicide risk (has ideation, plan, and intent); (3) Is currently receiving psychotherapy or intends to commence it in the next 8 weeks; (4) Psychiatric medication dose change in the past 4 weeks, or has plans to change the dose of a psychiatric medication

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Adaptive Messaging Intervention
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.
• Non-Adaptive Messaging Intervention
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.
• Psychoeducation-Only Control
An active control which will deliver psychoeducational content via clickable URLs over 8 weeks.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).