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Digital Mental Health Service for Non-Treatment Seeking Young Adults

Primary Purpose

Depression, Anxiety, Suicidal Ideation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adaptive messaging intervention
Non-personalized messaging intervention
Coaching
Psychoeducational links
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Text messaging, Depression, Anxiety, Telemedicine, Digital Mental Health, mobile health (mHealth), Mobile phone, Technology assisted, Smartphone, Cell phone, Coach

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Exclusion Criteria:

  1. History of treatment with psychotherapy or psychiatric medication management;
  2. Seeking traditional mental health treatment;
  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.

Sites / Locations

  • Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Adaptive digital mental health intervention without coaching

Non-personalized digital Mental Health intervention without coaching

Adaptive digital mental health intervention with coaching

Non-personalized digital Mental Health intervention with coaching

Active control

Arm Description

The adaptive intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content will be delivered via a URL in an SMS message. Machine learning will be used to tailor messages and timing to meet participant preferences.

The non-personalized intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content will not be tailored based on participants profile or usage.

The adaptive intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content will be delivered via a URL in an SMS message. Machine learning will be used to tailor messages and timing to meet participant preferences. Coaching will be provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).

The non-personalized intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content will not be tailored based on participants profile or usage. Coaching will be provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).

The active control condition will provide brief text messages that include a URL link to psychoeducational content, but will not include the interactive messaging component described in experimental arms.

Outcomes

Primary Outcome Measures

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
Engagement length
Last message/content rating or click on content URL link received from participant.

Secondary Outcome Measures

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
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

Full Information

First Posted
June 16, 2021
Last Updated
October 24, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04948268
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Suicidal Ideation
Keywords
Text messaging, Depression, Anxiety, Telemedicine, Digital Mental Health, mobile health (mHealth), Mobile phone, Technology assisted, Smartphone, Cell phone, Coach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adaptive digital mental health intervention without coaching
Arm Type
Experimental
Arm Description
The adaptive intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content will be delivered via a URL in an SMS message. Machine learning will be used to tailor messages and timing to meet participant preferences.
Arm Title
Non-personalized digital Mental Health intervention without coaching
Arm Type
Experimental
Arm Description
The non-personalized intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content will not be tailored based on participants profile or usage.
Arm Title
Adaptive digital mental health intervention with coaching
Arm Type
Experimental
Arm Description
The adaptive intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Psychoeducational content will be delivered via a URL in an SMS message. Machine learning will be used to tailor messages and timing to meet participant preferences. Coaching will be provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).
Arm Title
Non-personalized digital Mental Health intervention with coaching
Arm Type
Experimental
Arm Description
The non-personalized intervention will consist of SMS messages, symptom tracking, and psychological content that centers on evidence-based psychological strategies. Messages and content will not be tailored based on participants profile or usage. Coaching will be provided to support engagement and intervention use via medium of participants choice (texts, calls, or emails).
Arm Title
Active control
Arm Type
Active Comparator
Arm Description
The active control condition will provide brief text messages that include a URL link to psychoeducational content, but will not include the interactive messaging component described in experimental arms.
Intervention Type
Behavioral
Intervention Name(s)
Adaptive messaging intervention
Intervention Description
Psychological content and messages delivered regularly over an 8-week period via interactive SMS messages. Content and messages will be tailored using machine learning.
Intervention Type
Behavioral
Intervention Name(s)
Non-personalized messaging intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Coaching
Intervention Description
Human coaching to support intervention use and engagement via telephone calls, text or email
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational links
Intervention Description
SMS messages with URLs containing brief psychoeducational information.
Primary Outcome Measure Information:
Title
Kessler Psychological Distress Scale
Description
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
Time Frame
16 weeks
Title
Engagement length
Description
Last message/content rating or click on content URL link received from participant.
Time Frame
Up to 16 weeks
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire-9
Description
10-item self-report measure assessing depression symptom severity. Higher scores mean greater symptom severity. Minimum score: 0; maximum score: 27
Time Frame
16 weeks
Title
Generalized Anxiety Disorder-7
Description
8-item self-report measure assessing generalized anxiety disorder symptom severity Higher scores mean greater symptom severity. Minimum score: 0; maximum score: 21
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Objective engagement markers
Description
Number of message & content ratings, and content URL clicks.
Time Frame
16 weeks
Title
Cognitive Behavioral Response to Stress Scale
Description
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
Time Frame
16 weeks
Title
Depression Symptom Inventory - Suicidality Subscale
Description
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
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. A positive screen on an MHA screen for depression (Patient Health Questionnaire - 9 [PHQ-9]) or anxiety (Generalized Anxiety Disorder - 7 [GAD-7]); Resident of the United States. Owns a smartphone Exclusion Criteria: Current treatment with psychotherapy or psychiatric medication management; Seeking or plans to seek traditional mental health treatment (psychotherapy or psychiatric medication management) in next 8 weeks; Serious mental illness for which intervention would be contraindicated (e.g., psychotic disorder, manic episode, etc.) Severe suicidality (i.e., experiencing suicidal ideation with a plan and intent to act); English insufficient to engage in design activities.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonah Meyerhoff, PhD
Phone
312-503-1232
Email
jonah.meyerhoff@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
David C. Mohr, PhD
Phone
312-503-1403
Email
d-mohr@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C Mohr, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonah Meyerhoff, PhD
Phone
312-503-1232
Email
jonah.meyerhoff@northwestern.edu
First Name & Middle Initial & Last Name & Degree
David C Mohr, PhD
Phone
312-503-1403
Email
d-mohr@northwestern.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be shared through and managed by the National Institute of Mental Health (NIMH) Data Archive (NDA). De-identified human subjects data, harmonized to a common standard, are available to qualified researchers.
IPD Sharing Time Frame
Data will be available after publication of the primary outcome papers.
IPD Sharing Access Criteria
The NIMH Data Archive is managed by the NIMH. Access criteria are determined by the NIMH.
IPD Sharing URL
https://nda.nih.gov/

Learn more about this trial

Digital Mental Health Service for Non-Treatment Seeking Young Adults

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