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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH125152-01 | U.S. NIH Grant/Contract | View source |
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We were unable to obtain the intended sample size.
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| off-the-shelf digital CBT | Active Comparator | standard implementation strategy that has no content or references to SCD, chronic pain, or the unique challenges facing minority groups |
|
| adapted digital CBT | Experimental | has content or references to SCD, chronic pain, and the unique challenges facing minority groups |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| off-the-shelf digital CBT | Behavioral | Cognitive behavioral therapy for depression and anxiety |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of App Use | A measure of participant engagement. {Number of times the app has been open per week} | 4 weeks |
| Number of Lessons Completed | A measure of participant engagement. {Total number of lesson completed over the 4 week period} | 4 weeks |
| Number of Interactions (Text/Phone) With Health Coaches | A measure of participant engagement. {Average number of texts messages sent to their health coach over the treatment period} | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Baseline Pain Scale at 4 Weeks | The Pain scale asks participants to rank their average pain over the previous 7 days. The minimum score is 0. Maximum score is 10. The higher the score, the more severe the pain. (Value at Baseline -Value at 4 weeks = total change of average pain from baseline) | Baseline vs 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles R Jonassaint, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37023443 | Derived | Nikolajski C, O'Brien J, Nardo E, Szigethy E, Jonassaint C. Tailoring a Digital Mental Health Program for Patients With Sickle Cell Disease: Qualitative Study. JMIR Ment Health. 2023 Apr 6;10:e44216. doi: 10.2196/44216. |
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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.
The data will be available within 12 months of the completion of the trial. There will be no end date for its availability.
Investigators with approved Institutional Review Board (IRB) protocol can access the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 off-the-shelf digital CBT: Cognitive behavioral therapy for depression and anxiety |
| FG001 | Adapted Digital CBT | has content or references to SCD, chronic pain, and the unique challenges facing minority groups adapted digital CBT: Cognitive behavioral therapy for depression and anxiety for individuals from a minority group with SCD |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 off-the-shelf digital CBT: Cognitive behavioral therapy for depression and anxiety |
| BG001 | Adapted Digital CBT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of App Use | A measure of participant engagement. {Number of times the app has been open per week} | Posted | Mean | Standard Deviation | App opening per week | 4 weeks |
|
Data was collected for the duration of the study (4 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 off-the-shelf digital CBT: Cognitive behavioral therapy for depression and anxiety |
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The sample size was lower than originally expected for this study so we were unable to test for covariates; Difficulties with recruitment required that the eligibility criteria was widened part way through recruitment to increase the available population pool;
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles Jonassaint | University of Pittsburgh | +14125869850 | cjonassaint@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 26, 2022 | May 1, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| adapted digital CBT | Behavioral | Cognitive behavioral therapy for depression and anxiety for individuals from a minority group with SCD |
|
| Change in Baseline Patient Health Questionnaire (PHQ-9) at 4 Weeks |
A 9-item measure of depressive symptoms. The minimum score is 0. The maximum score is 27. The higher the total score, the more severe the depressive symptoms. (Value at Baseline- Value at 4 weeks - = total change of depressive symptoms from baseline) |
| Baseline vs 4 weeks |
| Change in Baseline Generalized Anxiety Disorder Scale (GAD-7) at 4 Weeks | A 7-item measure of anxiety. The minimum score is 0. The maximum score is 21. The higher the total score, the more severe the symptoms of anxiety. ( Value at Baseline - Value at 4 weeks ) = total change of average anxiety symptoms from baseline) | Baseline vs 4 weeks |
has content or references to SCD, chronic pain, and the unique challenges facing minority groups adapted digital CBT: Cognitive behavioral therapy for depression and anxiety for individuals from a minority group with SCD |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| PHQ score | This scale measures depressive symptoms with nine statements indicating how participants felt over the last 2 weeks. The scale asks for each statement "how many days have you been bothered by any of the following problems?" and provides a likert scale response ranging from 0-3 [0(not at all)-1(several days)-2( More than half the time)- 3 (All the time)]. | Mean | Standard Deviation | units on a scale |
|
| Pain | Mean | Standard Deviation | units on a scale |
|
| SCD Efficacy | Mean | Standard Deviation | units on a scale |
|
| GAD score | Mean | Standard Deviation | units |
|
|
|
| Primary | Number of Lessons Completed | A measure of participant engagement. {Total number of lesson completed over the 4 week period} | Posted | Mean | Standard Deviation | Lesson completed | 4 weeks |
|
|
|
| Primary | Number of Interactions (Text/Phone) With Health Coaches | A measure of participant engagement. {Average number of texts messages sent to their health coach over the treatment period} | Posted | Mean | Standard Deviation | Average text sent per week | 4 weeks |
|
|
|
| Secondary | Change in Baseline Pain Scale at 4 Weeks | The Pain scale asks participants to rank their average pain over the previous 7 days. The minimum score is 0. Maximum score is 10. The higher the score, the more severe the pain. (Value at Baseline -Value at 4 weeks = total change of average pain from baseline) | Posted | Mean | Standard Deviation | score on a scale | Baseline vs 4 weeks |
|
|
|
| Secondary | Change in Baseline Patient Health Questionnaire (PHQ-9) at 4 Weeks | A 9-item measure of depressive symptoms. The minimum score is 0. The maximum score is 27. The higher the total score, the more severe the depressive symptoms. (Value at Baseline- Value at 4 weeks - = total change of depressive symptoms from baseline) | Posted | Mean | Standard Deviation | units on a scale | Baseline vs 4 weeks |
|
|
|
| Secondary | Change in Baseline Generalized Anxiety Disorder Scale (GAD-7) at 4 Weeks | A 7-item measure of anxiety. The minimum score is 0. The maximum score is 21. The higher the total score, the more severe the symptoms of anxiety. ( Value at Baseline - Value at 4 weeks ) = total change of average anxiety symptoms from baseline) | Posted | Mean | Standard Deviation | score on a scale | Baseline vs 4 weeks |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Adapted Digital CBT | has content or references to SCD, chronic pain, and the unique challenges facing minority groups adapted digital CBT: Cognitive behavioral therapy for depression and anxiety for individuals from a minority group with SCD | 0 | 10 | 0 | 10 | 0 | 10 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |