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Sickle Cell DiseaseNCT04587661

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

A study testing off-the-shelf digital CBT and adapted digital CBT in people with Sickle Cell Disease and Depression, run by University of Pittsburgh at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 35 years
Conditions the study is for
Sickle Cell Disease, Depression, Anxiety
What is being tested?
off-the-shelf digital CBT and adapted digital CBT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
12 Aug 2020to 4 Jan 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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] > 4)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
off-the-shelf digital CBT, adapted digital CBT
Medical subject headings
Anemia, Sickle Cell, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • off-the-shelf digital CBTBehavioural

    Cognitive behavioral therapy for depression and anxiety

  • adapted digital CBTBehavioural

    Cognitive behavioral therapy for depression and anxiety for individuals from a minority group with SCD

Study groups in NCT04587661
Study groupRoleWhat they receive
off-the-shelf digital CBTActive comparatorstandard implementation strategy that has no content or references to SCD, chronic pain, or the unique challenges facing minority groups
Receives: Behavioral: off-the-shelf digital CBT
adapted digital CBTExperimentalhas content or references to SCD, chronic pain, and the unique challenges facing minority groups
Receives: Behavioral: adapted digital CBT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of App Use

    A measure of participant engagement.

    {Number of times the app has been open per week}

    Measured: 4 weeks

  2. Number of Lessons Completed

    A measure of participant engagement.

    {Total number of lesson completed over the 4 week period}

    Measured: 4 weeks

  3. 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}

    Measured: 4 weeks

Secondary outcomes (3)
  1. 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)

    Measured: Baseline vs 4 weeks

  2. 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)

    Measured: Baseline vs 4 weeks

  3. 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)

    Measured: Baseline vs 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start12 Aug 2020
  3. Primary completion7 Dec 2022
  4. Study completion4 Jan 2023

Why it stopped: We were unable to obtain the intended sample size.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04587661
Sponsor's protocol ID
STUDY20070307
Other IDs
R34MH125152-01
Status last verified
Apr 2024
First submitted
7 Oct 2020
Last updated
30 Apr 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37023443

Questions about this trial

What is this clinical trial studying?

A study testing off-the-shelf digital CBT and adapted digital CBT in people with Sickle Cell Disease and Depression, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of App Use (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04587661, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.

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