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Project 2: Optimizing Engagement and Outcomes in STAND Digital Therapy (P2)

Primary Purpose

Depression, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Demographic Matching
Supervision Intensity
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring personalized care, cognitive behavioral therapy, depression, anxiety

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Currently enrolled in the East Los Angeles College Either uninsured or covered by California Medicaid Own or have private access to internet to complete the assessments and online prevention and therapy programs Self-identify as Latinx. Exclusion Criteria: Unable to fully comprehend the consent form, respond adequately to screening questions, or maintain focus or to sit still during assessment Diagnosed with disorders requiring more specialized care (e.g., psychotic disorder, severe eating disorder, severe substance use disorder, severe neurological disorder), or marked cognitive impairment Currently treated by psychiatrist or psychologist during timeframe that the treatment is offered through STAND and is unwilling to fully transfer care to STAND

Sites / Locations

  • East Los Angeles CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

No Intervention

Arm Label

Aim 1

Aim 2

Aim 3

Arm Description

To examine the impact of demographic matching and supervision intensity on treatment engagement, treatment satisfaction, symptoms, and functioning for students receiving digital therapy. Hypothesis for Main Effect 1: Participants who are matched with Latinx peer coaches will show greater treatment engagement, satisfaction, and improvements in symptom and functioning relative to participants who are not. Hypothesis for Main Effect 2: Participants assigned to peer coaches in standard supervision will show greater treatment engagement, satisfaction, and improvements in symptom and functioning relative to those assigned to coaches in reduced supervision. Hypothesis for Interaction Effect: Students assigned to coaches who are demographically matched and receiving standard supervision will show greater treatment engagement, satisfaction, and improvements in symptom and functioning relative to those in all other conditions.

To examine explanatory/intervening variables impacting treatment engagement, treatment satisfaction, symptoms and functioning for students receiving digital therapy. Hypothesis 2: Evidence of mediation will be observed for the following five explanatory/intervening variables: 1) quality of the relationship between the participant and peer coach, 2) the participants' perception of cultural similarity with their coach, 3) the participants' treatment expectancy and treatment credibility, 4) the participants' perception of their peer coach's cultural competence, and 5) the peer coaches' fidelity to the treatment model.

To examine the cost-effectiveness of providing standard supervision. Hypothesis 3: Cost-effectiveness analyses will demonstrate that the increased costs incurred by standard supervision relative to reduced supervision will be justified by participants assigned to peer coaches receiving standard supervision experiencing greater improvements in symptoms than those assigned to peer coaches receiving reduced supervision.

Outcomes

Primary Outcome Measures

Engagement
Indexed by 1) proportion of digital therapy lessons completed and 2) proportion of coaching sessions attended.

Secondary Outcome Measures

Treatment satisfaction
Healthy Minds Survey: Treatment satisfaction. (1 item, scored on a 1 to 6 scale). Higher scores reflect greater treatment satisfaction with the digital therapy program.
Symptom severity for mental health
Computerized Adaptive Test - Mental Health (CAT-MH). Symptoms of depression and anxiety are assessed using item response theory (IRT), where a subset of items are selected from a pool of approximately 1000 questions based on participant impairment level. Higher scores reflect greater symptom severity.
Baseline social, occupational, and home functioning
Work and Social Adjustment Scale: functioning at work/school, home, social, and leisure activities (5 items, scored on a 0 to 8 scale). Higher scores reflect better adjustment.

Full Information

First Posted
May 23, 2023
Last Updated
June 9, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05908565
Brief Title
Project 2: Optimizing Engagement and Outcomes in STAND Digital Therapy
Acronym
P2
Official Title
Project 2: Optimizing Engagement and Outcomes in STAND Digital Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

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
The goal is to optimize peer coaching in order to optimize engagement and outcomes in digital therapy. The unmet mental health needs of community college students are staggering and a growing body of research demonstrates that therapy provided digitally with the assistance of trained community members without advanced degrees in mental health is an effective and scalable way to address these needs. Despite being effective for improving symptoms and functioning in those who engage in it, uptake and engagement in digital therapy is generally quite low. Recent research suggests that this is especially true of Latinx individuals, who tend to have unique and significant unmet mental health needs. To address these issues, Project 2 will examine treatment engagement, treatment satisfaction, symptoms and functioning outcomes among Latinx students at East Los Angeles College (ELAC) receiving digital therapy with peer coaching in the STAND program.
Detailed Description
A sample of 240 students who identify as Latinx will be recruited. A 2x2 design will randomize students to 1 of 4 peer coaching conditions (n = 60 per condition): 1) demographic matching + standard supervision, 2) demographic matching + reduced supervision, 3) no demographic matching + standard supervision, and 4) no demographic matching + reduced supervision. Students in the demographic matching condition will be assigned to peer coaches who also identify as Latinx, whereas those in the no demographic matching condition will be assigned to peer coaches who do not identify as Latinx. Supervision will either involve individual session review and personalized feedback or not. Students will participate in this project for 24 weeks and will complete brief weekly assessment batteries and longer assessment batteries at baseline and at weeks 8, 16 and 24. Explanatory/intervening variables that are hypothesized to explain treatment effects will also be explored. In addition to the quantitative data collected from the randomized controlled trial, we will collect and analyze qualitative data from the peer coaches via annual focus groups and will evaluate cost-effectiveness specifically focused on costs related to supervision. These data will inform the iterative refinements made to Tier II in the Signature Project.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
personalized care, cognitive behavioral therapy, depression, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aim 1
Arm Type
Active Comparator
Arm Description
To examine the impact of demographic matching and supervision intensity on treatment engagement, treatment satisfaction, symptoms, and functioning for students receiving digital therapy. Hypothesis for Main Effect 1: Participants who are matched with Latinx peer coaches will show greater treatment engagement, satisfaction, and improvements in symptom and functioning relative to participants who are not. Hypothesis for Main Effect 2: Participants assigned to peer coaches in standard supervision will show greater treatment engagement, satisfaction, and improvements in symptom and functioning relative to those assigned to coaches in reduced supervision. Hypothesis for Interaction Effect: Students assigned to coaches who are demographically matched and receiving standard supervision will show greater treatment engagement, satisfaction, and improvements in symptom and functioning relative to those in all other conditions.
Arm Title
Aim 2
Arm Type
No Intervention
Arm Description
To examine explanatory/intervening variables impacting treatment engagement, treatment satisfaction, symptoms and functioning for students receiving digital therapy. Hypothesis 2: Evidence of mediation will be observed for the following five explanatory/intervening variables: 1) quality of the relationship between the participant and peer coach, 2) the participants' perception of cultural similarity with their coach, 3) the participants' treatment expectancy and treatment credibility, 4) the participants' perception of their peer coach's cultural competence, and 5) the peer coaches' fidelity to the treatment model.
Arm Title
Aim 3
Arm Type
No Intervention
Arm Description
To examine the cost-effectiveness of providing standard supervision. Hypothesis 3: Cost-effectiveness analyses will demonstrate that the increased costs incurred by standard supervision relative to reduced supervision will be justified by participants assigned to peer coaches receiving standard supervision experiencing greater improvements in symptoms than those assigned to peer coaches receiving reduced supervision.
Intervention Type
Behavioral
Intervention Name(s)
Demographic Matching
Intervention Description
At randomization, students will be randomized to a Latinx or non-Latinx coach and will be informed whether or not their coach identifies as Latinx. Although we are not recruiting coaches or matching coaches with participants based on gender, gender identity or lived experience with mental health problems, we will collect these data from coaches in order to do conduct secondary exploratory analyses examining these variables as predictors or moderators of outcome.
Intervention Type
Behavioral
Intervention Name(s)
Supervision Intensity
Intervention Description
Coaches will be assigned to either standard supervision or reduced supervision, with equal distribution across Latinx vs non-Latinx. Coaches assigned to standard supervision will receive weekly supervision by a licensed provider consistent with the procedures outlined in the Data and Safety Monitoring Plan for the Signature Project. Coaches assigned to reduced supervision will attend weekly group supervision, but their session recordings or live sessions will not be reviewed by licensed supervisors or advanced peers and they will not receive personalized feedback about how they are performing in their sessions. Students will not be informed which supervision condition they have been assigned to in order to maintain high treatment expectancies. Of note, this design prohibits the coach and supervisors from being blind to participant condition.
Primary Outcome Measure Information:
Title
Engagement
Description
Indexed by 1) proportion of digital therapy lessons completed and 2) proportion of coaching sessions attended.
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Treatment satisfaction
Description
Healthy Minds Survey: Treatment satisfaction. (1 item, scored on a 1 to 6 scale). Higher scores reflect greater treatment satisfaction with the digital therapy program.
Time Frame
Up to 24 weeks
Title
Symptom severity for mental health
Description
Computerized Adaptive Test - Mental Health (CAT-MH). Symptoms of depression and anxiety are assessed using item response theory (IRT), where a subset of items are selected from a pool of approximately 1000 questions based on participant impairment level. Higher scores reflect greater symptom severity.
Time Frame
Up to 24 weeks
Title
Baseline social, occupational, and home functioning
Description
Work and Social Adjustment Scale: functioning at work/school, home, social, and leisure activities (5 items, scored on a 0 to 8 scale). Higher scores reflect better adjustment.
Time Frame
Baseline, Weeks 8, 16, and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Currently enrolled in the East Los Angeles College Either uninsured or covered by California Medicaid Own or have private access to internet to complete the assessments and online prevention and therapy programs Self-identify as Latinx. Exclusion Criteria: Unable to fully comprehend the consent form, respond adequately to screening questions, or maintain focus or to sit still during assessment Diagnosed with disorders requiring more specialized care (e.g., psychotic disorder, severe eating disorder, severe substance use disorder, severe neurological disorder), or marked cognitive impairment Currently treated by psychiatrist or psychologist during timeframe that the treatment is offered through STAND and is unwilling to fully transfer care to STAND
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew J Sanders, Ph.D.
Phone
310-206-4662
Email
ajsanders@mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tamar Kodish, Ph.D.
Email
tamarkodish@ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Sewart, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kate Taylor, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Los Angeles College
City
Los Angeles
State/Province
California
ZIP/Postal Code
91754
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Areli Vargas
Email
VARGASA3@ELAC.EDU

12. IPD Sharing Statement

Learn more about this trial

Project 2: Optimizing Engagement and Outcomes in STAND Digital Therapy

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