Designing an Implementation Strategy for Delivering Routine Mental Health Screening and Treatment

• ClinicalTrials.gov Identifier: NCT04587661
• Recruitment Status: Recruiting
• First Posted: October 14, 2020
• Last Update Posted: November 9, 2022
• Sponsor: University of Pittsburgh
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Charles Jonassaint, University of Pittsburgh

Tracking Information

• First Submitted Date: October 7, 2020
• First Posted Date: October 14, 2020
• Last Update Posted Date: November 9, 2022
• Actual Study Start Date: August 12, 2020
• Estimated Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 7, 2020)

• Total time spent on the app [ Time Frame: 4 weeks ]
  A measure of participant engagement.
• Frequency of app use [ Time Frame: 4 weeks ]
  A measure of participant engagement.
• Number of lessons completed [ Time Frame: 4 weeks ]
  A measure of participant engagement.
• Number of interactions (text/phone) with health coaches [ Time Frame: 4 weeks ]
  A measure of participant engagement.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 31, 2021)

• Change in baseline PROMIS Pain Interference Scale at 4 weeks [ Time Frame: Baseline vs 4 weeks ]
  The PROMIS® (Patient-Reported Outcomes Measurement Information System) Pain Interference Scale is a validated questionnaire asking a patient how much day-to-day function is altered by pain. Minimum score is 8. Maximum score is 40. The higher the total score, the more severe the symptoms.
• Change in baseline Patient Health Questionnaire (PHQ-9) at 4 weeks [ Time Frame: Baseline vs 4 weeks ]
  A 9-item measure of depressive symptoms. Minimum score is 0. Maximum score is 27. The higher the total score, the more severe the symptoms.
• Change in baseline Generalized Anxiety Disorder Scale (GAD-7) at 4 weeks [ Time Frame: Baseline vs 4 weeks ]
  a 7-item measure of anxiety. Minimum score is 0. Maximum score is 21. The higher the total score, the more severe the symptoms.

Original Secondary Outcome Measures (submitted: October 7, 2020)

• Change in baseline PROMIS Pain Interference Scale at 4 weeks [ Time Frame: Baseline vs 4 weeks ]
  The PROMIS Pain Interference Scale is a validated questionnaire asking a patient how much day-to-day function is altered by pain. Minimum score is 8. Maximum score is 40. The higher the total score, the more severe the symptoms.
• Change in baseline Patient Health Questionnaire (PHQ-9) at 4 weeks [ Time Frame: Baseline vs 4 weeks ]
  A 9-item measure of depressive symptoms. Minimum score is 0. Maximum score is 27. The higher the total score, the more severe the symptoms.
• Change in baseline Generalized Anxiety Disorder Scale (GAD-7) at 4 weeks [ Time Frame: Baseline vs 4 weeks ]
  a 7-item measure of anxiety. Minimum score is 0. Maximum score is 21. The higher the total score, the more severe the symptoms.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Designing an Implementation Strategy for Delivering Routine Mental Health Screening and Treatment
• Official Title: Designing an Implementation Strategy for Delivering Routine Mental Health Screening and Treatment for Adolescents and Adults With Sickle Cell Disease

Brief Summary

African Americans living with chronic health conditions are more likely to experience depression and other mental health disorders than their healthy counterparts, and are more likely to experience severe depression than whites, but less likely to be diagnosed or receive treatment. One especially vulnerable group is patients with sickle cell disease (SCD), a genetic blood disorder that primarily affects people of African descent, many of whom live in disadvantaged circumstances and are cared for in under-resourced settings. SCD causes severe acute and chronic pain, end-organ damage, and early mortality. Patients transitioning from adolescence to adulthood (ages16-30) are at high risk for mental health disorders and suicide.

Using mobile technology, the investigators can provide high-quality, evidence-based behavioral mental health treatment that reaches patients in different settings. Digital cognitive behavioral therapy (CBT) is effective for treating depression and anxiety and can be brought to scale at low cost. Despite the promise of digital CBT, there are barriers to its widespread use, particularly in low-resource settings serving minorities. Qualitative data show that cultural factors-lack of relatability, representation, and perceived stigma regarding mental health treatment-limit engagement with digital CBT programs. Population-and setting-specific adaptations to interventions can lead to their successful implementation and wider use. The investigators will work with a digital CBT program to decrease stigma and make it more relatable and relevant to young adults with SCD, by devising changes to advertising and promotion, and tailoring communication with an integrated health coach, Aim 1: Use implementation science (ImS) and human-centered design methods to define the barriers to delivering routine mental health screening and digital CBT to adolescents and young adults with SCD. Aim 2: Rapidly iterate, test, and evaluate adaptations to the implementation strategy for a coach-enhanced digital mental health service. Aim 3: Demonstrate that a population-specific implementation strategy improves engagement with a digital CBT-based mental health service.

The investigators will capitalize on our mobile technology tools, interdisciplinary expertise, and community-based partnerships to investigate the implementation of digital CBT into low-resource clinics and community-based organizations serving adolescents and adults with sickle cell disease.

Detailed Description

African Americans living with chronic medical conditions are at high risk for depression and other mental health disorders yet are less likely to be diagnosed or receive treatment than their white counterparts. Left untreated, depression can increase disease severity and risk for mortality. One especially vulnerable group is patients with sickle cell disease (SCD), a genetic blood disorder that primarily affects people of African descent and disproportionately impacts those living in disadvantaged circumstances. Sickle cell causes severe acute and chronic pain, end-organ damage, and early mortality. In SCD, the transition from adolescence to adulthood is a tumultuous period, characterized by social vulnerability, increased medical complications, and high health care utilization. Young adults in this age group, 16-30, are at high risk for mental health disorders and suicide.

Using mobile technology, the investigators can provide high-quality, evidence-based behavioral mental health treatment that reaches patients in under-resourced settings. Digital cognitive behavioral therapy (CBT), also known as computerized CBT, is effective for treating depression and anxiety, and can be easily brought to scale at low cost. Several meta-analyses have found digital CBT effective for treating depression and anxiety in white adults. The investigators' group has shown in a large-scale trial that it is effective for treating these symptoms among African American patients at 22 primary care clinics. In two adult sickle cell clinics, the investigators have shown that routine mental health screening and digital CBT delivered as part of usual care can improve depressive symptoms and daily pain among adults with SCD. The investigators' group has also used this method to treat pain in pediatric SCD patients.

Gap in evidence: Despite the promise of digital CBT, there are barriers to widespread use of this technology, particularly in low-resource settings serving minorities. Studies using digital CBT often suffer from high attrition and poor adherence. In real-world settings, uptake is poor even when the service is offered free of charge. These limitations affect patients living with SCD. The investigators will modify how a digital CBT program for mental health is delivered to these patient sat the patient, provider, and organizational levels, by adding references and content representing SCD, chronic pain, and stressors unique to African Americans. The investigators believe this approach will radically improve the implementation of mental health screening and treatment in low-resource settings such as clinics and community organizations serving adolescents and adults with SCD, and similar communities.

Strategy and goals: Population-and setting-specific adaptations to interventions can lead to their successful implementation and wider use, yet no studies show how much adaptation is needed to effectively implement digital CBT in different settings. Qualitative data from The investigators' group and others show that cultural factors-lack of relatability, representation, and perceived stigma regarding mental health treatment-limit engagement with digital CBT programs. The investigators' proposal will devise changes to advertising, promotion, and health coach communications, that will decrease stigma and make digital CBT more relatable and relevant to young adults with SCD. The investigators hypothesize that low-cost adaptations to a digital CBT program will have better engagement than digital CBT with standard implementation strategy.

Aim 1: Use implementation science (ImS) and human-centered design methods to define the barriers to delivering routine mental health screening and digital CBT to adolescents and young adults with SCD. By leveraging ImS theory, models, and frameworks, The investigators will systematically collect and analyze qualitative data to define and understand the problem, stakeholder needs, and cultural barriers to routine mental health screening and treatment in SCD clinics and the community. Specifically, the investigators will use the Behavior Change Wheel as a validated method for identifying the appropriate behavior change and implementation strategies.

Aim 2: Rapidly iterate, test, and evaluate adaptations to the implementation strategy for a coach-enhanced digital mental health service. Based on findings from Aim 1, the investigators will systematically develop, test, and evaluate changes to how the CBT program is advertised/promoted, and introduced to patients and providers. The investigators will tailor the messages and multimedia content that health coaches send to patients.

Aim 3: Demonstrate that a population-specific implementation strategy improves engagement with a digital CBT-based mental health service. The investigators will recruit 40 adolescents and young adults with SCD (ages 16-30) and comorbid depression and randomize them to either the off-the-shelf digital CBT program and standard implementation strategy that has no content or references to SCD, chronic pain, or the unique challenges facing minority groups, to adapted digital CBT with a SCD-specific implementation approach.

Addressing mental health in SCD is a major step to delivering quality care and improving outcomes for this, and other hard-to-reach, minority populations. This study will generate the necessary data and infrastructure to conduct a large scale, R01-funded, multi-site pragmatic trial to determine how digital CBT can be used as an effective, low-cost, and scalable mental health treatment for adolescents and young adults with SCD.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Sickle Cell Disease
• Depression
• Anxiety

Intervention

• Behavioral: off-the-shelf digital CBT
  Cognitive behavioral therapy for depression and anxiety
• Behavioral: adapted digital CBT
  Cognitive behavioral therapy for depression and anxiety for individuals from a minority group with SCD

Study Arms

• Active Comparator: off-the-shelf digital CBT
  standard implementation strategy that has no content or references to SCD, chronic pain, or the unique challenges facing minority groups
  Intervention: Behavioral: off-the-shelf digital CBT
• Experimental: adapted digital CBT
  has content or references to SCD, chronic pain, and the unique challenges facing minority groups
  Intervention: Behavioral: adapted digital CBT

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 7, 2020): 40
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2022
• Estimated Primary Completion Date: November 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• have a diagnosis of SCD (any genotype)
• report significant depression or anxiety symptoms (i.e., Patient Health Questionnaire [PHQ-9] or Generalized Anxiety Disorder Scale [GAD-7] > 10)

Exclusion Criteria:

• Unable to read English or understand the consent process
• Cognitively impaired adults as determined by their treating physician
• Any condition that in the opinion of the investigator would not allow the patient to continue on the study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 30 Years (Child, Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Emily Nardo, MA; 412-438-3116; EVN11@pitt.edu

Contact: Cheryl Leow, RN; CSL28@pitt.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04587661
• Other Study ID Numbers: STUDY20070307; R34MH125152-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes

Plan Description

Results from research conducted under this project will be shared in several ways. Manuscripts will be submitted for publication in high-quality peer-reviewed journals, following the NIH Public Access Policy guidelines. Findings will be presented at relevant national conferences, public lectures, scientific institutions, and meetings.

The study datasets will be archived and made available to qualified individuals after a period of exclusive use by the research teams and after publication of the primary manuscripts, following NIH guidelines. The investigators will invite other investigators to submit ancillary studies using the data from the pilot trial and will work with those investigators to foster additional research studies and manuscripts.

• Supporting Materials: Study Protocol
• Time Frame: The data will be available within 12 months of the completion of the trial. There will be no end date for its availability.
• Access Criteria: Investigators with approved Institutional Review Board (IRB) protocol can access the data.

• Current Responsible Party: Charles Jonassaint, University of Pittsburgh
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Pittsburgh
• Original Study Sponsor: Same as current
• Collaborators: National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Charles R Jonassaint, PhD; University of Pittsburgh

• PRS Account: University of Pittsburgh
• Verification Date: November 2022