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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04587661
Recruitment Status : Not yet recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Charles Jonassaint, University of Pittsburgh

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.


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Depression Anxiety Behavioral: off-the-shelf digital CBT Behavioral: adapted digital CBT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Designing an Implementation Strategy for Delivering Routine Mental Health Screening and Treatment for Adolescents and Adults With Sickle Cell Disease
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Total time spent on the app [ Time Frame: 4 weeks ]
    A measure of participant engagement.

  2. Frequency of app use [ Time Frame: 4 weeks ]
    A measure of participant engagement.

  3. Number of lessons completed [ Time Frame: 4 weeks ]
    A measure of participant engagement.

  4. Number of interactions (text/phone) with health coaches [ Time Frame: 4 weeks ]
    A measure of participant engagement.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Sophy J Perdomo, PhD 4126247000 sjp80@pitt.edu
Contact: Jude Jonassaint, RN jonassaintjc@upmc.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ashley Connor    412-802-8498    connora2@upmc.edu   
Contact: Grace Checo       checoga@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Charles R Jonassaint, PhD University of Pittsburgh
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Responsible Party: Charles Jonassaint, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04587661    
Other Study ID Numbers: STUDY20070307
R34MH125152-01 ( U.S. NIH Grant/Contract )
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (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 IRB protocol can access the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn