Designing an Implementation Strategy for Delivering Routine Mental Health Screening and Treatment
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|ClinicalTrials.gov Identifier: NCT04587661|
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : November 9, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Depression Anxiety||Behavioral: off-the-shelf digital CBT Behavioral: adapted digital CBT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Designing an Implementation Strategy for Delivering Routine Mental Health Screening and Treatment for Adolescents and Adults With Sickle Cell Disease|
|Actual Study Start Date :||August 12, 2020|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2022|
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
Behavioral: off-the-shelf digital CBT
Cognitive behavioral therapy for depression and anxiety
Experimental: adapted digital CBT
has content or references to SCD, chronic pain, and the unique challenges facing minority groups
Behavioral: adapted digital CBT
Cognitive behavioral therapy for depression and anxiety for individuals from a minority group with SCD
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04587661
|Contact: Emily Nardo, MA||412-438-3116||EVN11@pitt.edu|
|Contact: Cheryl Leow, RN||CSL28@pitt.edu|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Cheryl Leow, MA 703-867-1220 CSL28@pitt.edu|
|Principal Investigator:||Charles R Jonassaint, PhD||University of Pittsburgh|