Digital Mental Health Service for Non-Treatment Seeking Young Adults

Depression Clinical Trial

Official title:

Digital Mental Health Service for Non-Treatment Seeking Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04948268
• Other study ID #: R34MH124960
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Northwestern University
• Contact: Jonah Meyerhoff, PhD
• Phone: 312-503-1232
• Email: jonah.meyerhoff[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a feasibility trial of a personalized 8-week text messaging intervention aimed at young adults (ages 18-25) with depression and anxiety who are not interested in -- or experience barriers to -- receiving traditional face-to-face psychological treatments.

The trial will consist of a pilot test of (1) an 8-week adaptive (personalized) messaging intervention relative to (2) a non-personalized digital mental health intervention, or (3) an active control which will send weekly psychoeducation information by way of Uniform Resource Locators (URLs). The adaptive intervention will uses machine learning to tailor Short Message Service (SMS) messages to an individual's needs and preferences, and URL links to provide access to psychoeducational content to contextualize messages, when the length of that content exceeds the limitations of messages.

The primary goals of the project are to conduct a feasibility trial using a sequential multiple assignment randomized treatment (SMART) design, which will evaluate (a) the effectiveness of an adaptive, personalized messaging intervention in reducing engagement relative to a non-personalized version; and (b) whether human coaching results in greater symptom reduction and engagement, relative an unguided implementation.

Description:

The primary purpose of this trial is to test the feasibility of conducting a randomized controlled trial of digital mental health intervention (DMHI) for non-treatment seeking young adults with symptoms of depression or anxiety, comparing an 8-week adaptive (personalized) messaging intervention, an 8-week non-personalized digital mental health intervention, or an active control which will deliver psychoeducational content via clickable URLs. The adaptive intervention will be powered by reinforcement learning to deliver tailored SMS messages based on user profiles and the ways in which a user interacts with the intervention system, along with links to longer psychoeducational content. The non-personalized intervention arm will not personalize the messages, but will still be an active treatment. This study will examine the adaptive intervention's ability to engage users and effectiveness in decreasing psychological distress relative to a non-personalized intervention. Participants who become disengaged (5 continuous days of not clicking on content URL links, responding to messages, or message ratings) from the adaptive or static intervention arms at any point in the first two weeks of treatment will be randomized to receive low-intensity human coaching or continue without coaching for the remainder of the intervention period.

Recruitment will take place via Mental Health America's (MHA) website. MHA is a large mental health advocacy organization that hosts online screeners and has large number of visitors the majority of whom meet clinical cutoffs for depressive or anxiety disorder symptoms. This study will enroll individuals who have completed a depression or anxiety disorder screener on MHA's website, and meet clinical cut-offs on the Patient Health Questionnaire - 9 (PHQ-9) or Generalized Anxiety Disorder - 7 (GAD-7).

Initial randomization will be generated in permuted blocks of 5 using a computer program. To prevent allocation bias, randomization will be conducted by the biostatistician, who will not inform the study team of the treatment arms until the baseline assessment has been completed and the patient has been enrolled. Second randomization of disengaged participants will occur as disengagement is detected during the first two weeks. Half (50%) of disengaged individuals will be randomized to receive additional human coaching throughout the remainder of the study while remaining in either the adaptive or non-personalized treatment arms. The disengaged participants not randomized to receive additional human coaching will continue to receive either the non-personalized or adaptive automated treatment the participants were randomized to initially.

Coaching will consist of providing users with support and accountability via positive reinforcement, goal and expectation setting, and monitoring. Coaching outreach will focus on adherence to the treatment but will not provide treatment advice. Coaches will provide a brief (15-minute phone call or equivalent depending on the medium) engagement session over the phone, SMS, or email, depending user preference. Thereafter, coaches will check in with participants via messaging, phone call, or email, twice per week and respond to patient texts.

Participants will be assessed using self-report measures at baseline, weeks 4, 8, 12, and 16 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

1. Ages 18 to 25 *The age to provide consent in Nebraska is 19. Individuals recruited from the state of Nebraska must be 19 or older.

2. A positive screen on an MHA screen for depression (Patient Health Questionnaire - 9 [PHQ-9]) or anxiety (Generalized Anxiety Disorder - 7 [GAD-7]);

3. Resident of the United States.

4. Owns a smartphone

Exclusion Criteria:

1. Current treatment with psychotherapy or psychiatric medication management;

2. Seeking or plans to seek traditional mental health treatment (psychotherapy or psychiatric medication management) in next 8 weeks;

3. Serious mental illness for which intervention would be contraindicated (e.g., psychotic disorder, manic episode, etc.)

4. Severe suicidality (i.e., experiencing suicidal ideation with a plan and intent to act);

5. English insufficient to engage in design activities.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Suicidal Ideation

Intervention

Behavioral:
• Adaptive messaging intervention
Psychological content and messages delivered regularly over an 8-week period via interactive SMS messages. Content and messages will be tailored using machine learning.
• Non-personalized messaging intervention
Psychological content and messages delivered regularly over an 8-week period via interactive SMS messages. Psychological content will center on a single psychological strategy each week. There will not be any tailoring of messaging and content based on group or individual level data.
• Coaching
Human coaching to support intervention use and engagement via telephone calls, text or email
• Psychoeducational links
SMS messages with URLs containing brief psychoeducational information.

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
Other	Objective engagement markers	Number of message & content ratings, and content URL clicks.	16 weeks
Other	Cognitive Behavioral Response to Stress Scale	9-item self-report measure of behavioral and cognitive coping related skills. Higher scores indicate greater adaptive cognitive and behavioral skills use.; Two domains: Use and usefulness. For each domain, minimum score: 0; maximum score: 54	16 weeks
Other	Depression Symptom Inventory - Suicidality Subscale	4-item self-report questionnaire assessing the frequency and intensity of suicidal thoughts over previous two weeks.; Higher scores signal greater frequency and severity of suicidal thoughts. Minimum score: 0; maximum score: 12	16 weeks
Primary	Kessler Psychological Distress Scale	10-item self-report measure of transdiagnostic distress, used as outcome measure across diagnostic categories. Higher scores mean greater distress. Minimum score: 10; maximum score: 50	16 weeks
Primary	Engagement length	Last message/content rating or click on content URL link received from participant.	Up to 16 weeks
Secondary	Patient Health Questionnaire-9	10-item self-report measure assessing depression symptom severity. Higher scores mean greater symptom severity. Minimum score: 0; maximum score: 27	16 weeks
Secondary	Generalized Anxiety Disorder-7	8-item self-report measure assessing generalized anxiety disorder symptom severity Higher scores mean greater symptom severity. Minimum score: 0; maximum score: 21	16 weeks