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Using Machine Learning to Optimize User Engagement and Clinical Response to Digital Mental Health Interventions

Primary Purpose

Anxiety Disorders and Symptoms, Depressive Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)
Space for depression
Space for resilience
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders and Symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • English-speaking adults
  • Ages 18 or older
  • Have a device that can connect to the internet.

Sites / Locations

  • Center for Anxiety and Related DisordersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)

Space from Depression (SFD)

Space for Resilience (SFR)

Arm Description

Digital, transdiagnostic, emotion-focused CBT intervention that consists of five "core" modules or components that have been shown to target temperamental characteristics (i.e., neuroticism) and resulting emotion dysregulation that are believed to underlie all anxiety, depressive, and emotional disorders. The core components of the program are psychoeducation, mindfulness, cognitive flexibility, behavioral strategies to counter emotion-driven behaviors, interoceptive, and emotion exposures.

Digital CBT program designed to minimize the impact of depressive symptoms. This program emphasizes the use of cognitive behavioral strategies as well as mindfulness through a series of seven structured modules. The core components of the program include psychoeducation around the relationship between thoughts, feelings, and behaviors; cognitive behavioral practices aimed at restructuring negative beliefs; behavioral strategies to improve self-esteem; and mindfulness techniques that focus attention on the present moment.

Digital program based on positive psychology principles and designed to promote resilience and well-being through a series of seven modules. The core components of the program include psychoeducation, values exploration, building relationships, promoting self-esteem and self-efficacy, and building gratitude and optimism.

Outcomes

Primary Outcome Measures

Change from baseline well-being at week 12
World Health Organization-Five (WHO-5) is a 5-item self-report questionnaire of psychological well being. The WHO-5 has demonstrated good validity and utility as an outcome measure in clinical trials including several digital intervention trials. Respondents rate each statement in relation to the past two weeks on a scale ranging from 0= At no time to 5= All the time (Ware, 1995).

Secondary Outcome Measures

Change from baseline anxiety at week 12
Generalized Anxiety Disorder-7 (GAD-7) is a reliable and valid self-report measure of symptoms of generalized anxiety that is widely used in clinical research. This measures consists of 7 questions in a likert scale format, and respondents rate each question on a scale ranging 0=Not at all or 3= Nearly every day, indicating how often they experience anxiety-related problems (Spitzer, Kroenke, Williams, Lowe, 2006).
Change in baseline depression at week 12
Patient Health Questionnaire 9 (PHQ-9) is a reliable and valid self-report measure of depression symptoms that is widely used in clinical research. Consisting of 9 questions, respondents rate each question on a scale ranging 0= Not at all or 3= Nearly every day, indicating how often they experience depression-related problems (Pfizer, 1999).

Full Information

First Posted
September 13, 2022
Last Updated
April 13, 2023
Sponsor
Boston University Charles River Campus
Collaborators
National Institute of Mental Health (NIMH), Silver Cloud Health, Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT05567640
Brief Title
Using Machine Learning to Optimize User Engagement and Clinical Response to Digital Mental Health Interventions
Official Title
Using Machine Learning to Optimize User Engagement and Clinical Response to Digital Mental Health Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University Charles River Campus
Collaborators
National Institute of Mental Health (NIMH), Silver Cloud Health, Kaiser Permanente

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
Digital mental health interventions are a cost-effective and efficient approach to expanding the accessibility and impact of psychological treatments; however, little guidance exists for selecting the most effective program for a given individual. In the proposed study, decision rules will develop for selecting the digital program that is most likely to be the optimal intervention for each user. These treatment recommendations can be implemented in the context of large healthcare delivery systems to improve the delivery of digital mental health interventions at scale. The overarching aim of the current study is to better understand for whom and how leading digital interventions work in a large healthcare setting. The study builds on the existing literature and follows expert recommendations by using machine learning (ML) methods to develop precision treatment rules (PTRs) for three leading digital interventions for emotional disorders (e.g., anxiety, depression, and related mental health disorders). Specifically, ML methods will be used to develop PTRs to optimize clinical outcomes and associated intervention engagement. This study will leverage a unique partnership between Boston University (BU), SilverCloud Health (SC)--a leading provider of digital mental health care--and Kaiser Permanente (KP)--one of America's leading health care providers. A clinical trial (RCT) will be conducted to evaluate the relative effectiveness of three distinct empirically supported digital mental health interventions (from SC's existing library of programs) in a sample recruited from KP primary care and other clinical settings. Data from this trial will be used to develop theoretically and empirically informed, reliable selection algorithms for managing treatment delivery decisions. Algorithms will be validated in a separate "holdout" dataset by examining whether allocation to predicted optimal treatment is associated with superior outcomes compared to allocation to a non-optimal treatment. The role of user engagement will be determined, and other mechanisms in treatment outcome.
Detailed Description
Kaiser Permanente (KP) members referred to SilverCloud Health (SC) through established operating procedures will be eligible to participate. After referral, potential participants will be informed of the study through the SC digital health platform. Interested participants will be provided information about the study through a digital version of an approved consent form. After signing consent, participants will complete baseline assessment questionnaires through Qualtrics, an online data collection platform. After completing the baseline assessment, eligible participants will be randomly assigned to one of three existing digital mental health interventions hosted by SC: (1) Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), (2) Space from Depression (SFD), and (3) Space for Resilience (SFR). A SC program supporter will also be established at that time. This differs from standard operating procedures at SC in that participants are generally able to select their preferred program from SC's offerings. There is nothing that would preclude participants from seeking a different SC treatment following study participation. Potential participants will have up to two weeks to enroll in the study, complete the baseline assessment, and begin a treatment program. If the participant does not initiate treatment within two weeks, they will be withdrawn from the study though they may continue with clinical services at SC. Following randomization, study staff at BU will send participants Qualtrics questionnaires via email throughout the treatment phase of the study, at 4-, 8-, and 12-weeks after treatment is initiated. The participant completes these questionnaires online. Regular asynchronous written support will be provided by SC supporters, consistent with their standard procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders and Symptoms, Depressive Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)
Arm Type
Experimental
Arm Description
Digital, transdiagnostic, emotion-focused CBT intervention that consists of five "core" modules or components that have been shown to target temperamental characteristics (i.e., neuroticism) and resulting emotion dysregulation that are believed to underlie all anxiety, depressive, and emotional disorders. The core components of the program are psychoeducation, mindfulness, cognitive flexibility, behavioral strategies to counter emotion-driven behaviors, interoceptive, and emotion exposures.
Arm Title
Space from Depression (SFD)
Arm Type
Active Comparator
Arm Description
Digital CBT program designed to minimize the impact of depressive symptoms. This program emphasizes the use of cognitive behavioral strategies as well as mindfulness through a series of seven structured modules. The core components of the program include psychoeducation around the relationship between thoughts, feelings, and behaviors; cognitive behavioral practices aimed at restructuring negative beliefs; behavioral strategies to improve self-esteem; and mindfulness techniques that focus attention on the present moment.
Arm Title
Space for Resilience (SFR)
Arm Type
Active Comparator
Arm Description
Digital program based on positive psychology principles and designed to promote resilience and well-being through a series of seven modules. The core components of the program include psychoeducation, values exploration, building relationships, promoting self-esteem and self-efficacy, and building gratitude and optimism.
Intervention Type
Behavioral
Intervention Name(s)
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)
Intervention Description
This is a cognitive behavioral treatment (CBT) for emotional disorders. This transdiagnostic intervention consists of eight modules and can be effectively applied to various disorders and problems.
Intervention Type
Behavioral
Intervention Name(s)
Space for depression
Intervention Description
Digital CBT program designed to minimize the impact of depression symptoms. Emphasizes CBT strategies and mindfulness through a series of seven structured modules.
Intervention Type
Behavioral
Intervention Name(s)
Space for resilience
Intervention Description
This program is built from positive psychology principles and is designed to promote resilience and well-being through seven modules.
Primary Outcome Measure Information:
Title
Change from baseline well-being at week 12
Description
World Health Organization-Five (WHO-5) is a 5-item self-report questionnaire of psychological well being. The WHO-5 has demonstrated good validity and utility as an outcome measure in clinical trials including several digital intervention trials. Respondents rate each statement in relation to the past two weeks on a scale ranging from 0= At no time to 5= All the time (Ware, 1995).
Time Frame
Baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline
Secondary Outcome Measure Information:
Title
Change from baseline anxiety at week 12
Description
Generalized Anxiety Disorder-7 (GAD-7) is a reliable and valid self-report measure of symptoms of generalized anxiety that is widely used in clinical research. This measures consists of 7 questions in a likert scale format, and respondents rate each question on a scale ranging 0=Not at all or 3= Nearly every day, indicating how often they experience anxiety-related problems (Spitzer, Kroenke, Williams, Lowe, 2006).
Time Frame
Baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline
Title
Change in baseline depression at week 12
Description
Patient Health Questionnaire 9 (PHQ-9) is a reliable and valid self-report measure of depression symptoms that is widely used in clinical research. Consisting of 9 questions, respondents rate each question on a scale ranging 0= Not at all or 3= Nearly every day, indicating how often they experience depression-related problems (Pfizer, 1999).
Time Frame
Baseline, 4-weeks following baseline, 8-weeks following baseline, and 12-weeks following baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English-speaking adults Ages 18 or older Have a device that can connect to the internet.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Todd Farchione, Ph.D.
Phone
(617) 353-9610
Email
tfarchio@bu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Rosellini, Ph.D.
Phone
(617) 353-9610
Email
ajrosell@bu.edu
Facility Information:
Facility Name
Center for Anxiety and Related Disorders
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Farchione, Ph.D.
Phone
617-353-9610
Email
tfarchio@bu.edu

12. IPD Sharing Statement

Learn more about this trial

Using Machine Learning to Optimize User Engagement and Clinical Response to Digital Mental Health Interventions

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