Adaptive Messaging for Depression

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

Disqualifiers: Severe mental health, High suicide risk, Psychotherapy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you cannot join if you've changed your psychiatric medication dose in the past 4 weeks or plan to change it during the trial.

What data supports the effectiveness of the Adaptive Messaging Intervention for depression?

Research shows that using text messaging as a support to traditional therapy can help people with depression by reminding them to do activities that improve their mood and by tracking their progress. In one study, patients who received supportive text messages reported positive experiences and responded well to the messages, suggesting that this approach can be a helpful and cost-effective way to support mental health care. ^{1 2 3 4 5}

Is Adaptive Messaging for Depression safe for humans?

Research on text messaging interventions for depression shows they are generally safe, with no reports of harmful effects like misreading data or privacy issues. Participants in studies have reported positive experiences with these interventions. ^{1 4 6 7 8}

How is the Adaptive Messaging Intervention treatment for depression different from other treatments?

The Adaptive Messaging Intervention for depression is unique because it uses personalized text messages to help maintain treatment outcomes by encouraging adaptive emotional regulation, unlike traditional treatments that may not offer ongoing, personalized support. ^{1 3 9 10 11}

Research Team

Eligibility Criteria

This trial is for individuals experiencing elevated symptoms of depression. Participants will be recruited digitally and must be willing to engage with text messaging interventions over an 8-week period, followed by a 6-month post-treatment follow-up.

Inclusion Criteria

US citizen or resident

Has a smartphone

Is able to speak and read English

Exclusion Criteria

I am currently in psychotherapy or plan to start within 8 weeks.

High suicide risk (has ideation, plan, and intent)

Reports diagnosis with a severe mental health problem (e.g., psychotic, bipolar) for which participation in this trial is inappropriate

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 8 weeks of daily text messaging interventions, either adaptive or non-adaptive, or a psychoeducation-only intervention

8 weeks

Daily text messages

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3-month and 6-month intervals

6 months

Assessments at 3-month and 6-month intervals

Treatment Details

Interventions

• Adaptive Messaging Intervention (Behavioural Intervention)
• Non-Adaptive Messaging Intervention (Behavioural Intervention)
• Psychoeducation-Only Control (Behavioural Intervention)

Trial Overview The study tests three approaches: adaptive text messaging that evolves based on user engagement, non-adaptive random messaging, and a control group receiving psychoeducation links. The goal is to see which method best supports depression self-management.

Participant Groups

Group I: Non-Adaptive Messaging Intervention Experimental Treatment 1 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.

Group II: Adaptive Messaging Intervention Experimental Treatment 1 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. The intervention will apply reinforcement learning to select daily messaging styles to maximize user engagement.

Group III: Psychoeducation-only control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

Findings from Research

This study aims to evaluate the effectiveness of different reminder methods (text messages, reminder calls, or both) in increasing the use of service referrals among 300 participants from community outreach programs.

The research will help determine how mobile phone-based interventions can enhance community engagement and service utilization, potentially guiding future reminder protocols for similar programs across the country.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Research Protocol to Test the Effectiveness of Text Messaging and Reminder Calls to Increase Service Use Referrals in a Community Engagement Program. Varma, DS., Hart, M., McIntyre, DS., et al.[2020]

A study involving 226 individuals with Major Depressive Disorder showed that a text-message-based maintenance intervention (TMMI-D) using standardized messages significantly reduced the increase in depressive symptoms compared to a waitlist control group.

Interestingly, the individualized message version of TMMI-D did not show the same effectiveness, suggesting that standardized messages focusing on adaptive emotion regulation may be more beneficial for sustaining treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a text-message-based maintenance intervention for Major Depressive Disorder after inpatient cognitive behavioral therapy. Schlicker, S., Ebert, DD., Middendorf, T., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Text Messaging as an Adjunct to CBT in Low-Income Populations: A Usability and Feasibility Pilot Study. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

A comparison between phone-based psychotherapy with and without text messaging support in between sessions for crisis patients. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Systematic review of the information and communication technology features of web- and mobile-based psychoeducational interventions for depression. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Randomized controlled pilot trial of supportive text messages for patients with depression. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Immediate and long-term effectiveness of adding an Internet intervention for depression to routine outpatient psychotherapy: Subgroup analysis of the EVIDENT trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Delivering interventions for depression by using the internet: randomised controlled trial. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

A Research Protocol to Test the Effectiveness of Text Messaging and Reminder Calls to Increase Service Use Referrals in a Community Engagement Program. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial evaluating a manualized TeleCoaching protocol for improving adherence to a web-based intervention for the treatment of depression. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of a text-message-based maintenance intervention for Major Depressive Disorder after inpatient cognitive behavioral therapy. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

How individuals change during internet-based interventions for depression: A randomized controlled trial comparing standardized and individualized feedback. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Blending group-based psychoeducation with a smartphone intervention for the reduction of depressive symptoms: results of a randomized controlled pilot study. [2021]