Clinical trial NCT04948268: Digital Mental Health Service for Non-Treatment Seeking Young Adults
Official title: Digital Mental Health Service for Non-Treatment Seeking Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Suicidal Ideation
Keywords: Text messaging
Depression
Anxiety
Telemedicine
Digital Mental Health
mobile health (mHealth)
Mobile phone
Technology assisted
Smartphone
Cell phone
Coach
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This study uses a sequential multiple assignment randomized trial (SMART) design. The first level of randomization is to one of the three treatment conditions: self-guided non-personalized intervention, self-guided adaptive intervention, or active control. The second level of randomization occurs during the first two weeks of intervention. Participants who meet criteria for disengagement from either the non-personalized or adaptive intervention are then randomized to receive coaching or continue as self-guided. This will provide the investigators with preliminary information on the need for and value of coaching. Participants will receive the assigned intervention from baseline to week 8, followed by an 8 week follow-up period
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Kessler Psychological Distress Scale
timeFrame: 16 weeks
measure: Engagement length
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: 16 weeks
measure: Generalized Anxiety Disorder-7
timeFrame: 16 weeks
Other outcomes:
measure: Objective engagement markers
timeFrame: 16 weeks
measure: Cognitive Behavioral Response to Stress Scale
timeFrame: 16 weeks
measure: Depression Symptom Inventory - Suicidality Subscale
timeFrame: 16 weeks
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: David C Mohr, PhD
role: PRINCIPAL_INVESTIGATOR
References: