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

NCT04587661 | Terminated Results

• 2 other identifiers: STUDY20070307R34MH125152-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Depression; Anxiety

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Change in Baseline Pain Scale at 4 Weeks

  Baseline vs 4 weeks

• Change in Baseline Patient Health Questionnaire (PHQ-9) at 4 Weeks

  Baseline vs 4 weeks

• Change in Baseline Generalized Anxiety Disorder Scale (GAD-7) at 4 Weeks

  Baseline vs 4 weeks

Study Arms (2)

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

Behavioral: off-the-shelf digital CBT

adapted digital CBT

EXPERIMENTAL

has content or references to SCD, chronic pain, and the unique challenges facing minority groups

Behavioral: adapted digital CBT

Interventions

off-the-shelf digital CBT BEHAVIORAL

Cognitive behavioral therapy for depression and anxiety

off-the-shelf digital CBT

adapted digital CBT BEHAVIORAL

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

adapted digital CBT

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 37023443 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavioral Symptoms; Behavior; Mental Disorders

Limitations and Caveats

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;

Results Point of Contact

• Title: Dr. Charles Jonassaint
• Organization: University of Pittsburgh

cjonassaint@pitt.edu

+14125869850

Study Officials

• Charles R Jonassaint, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: August 12, 2020
• Primary Completion: December 7, 2022
• Study Completion: January 4, 2023
• Last Updated: April 30, 2024
• Results First Posted: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)