NCT04587661

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

Terminated NA Results posted Last updated 30 April 2024

What this trial tests

NA trial testing off-the-shelf digital CBT in Sickle Cell Disease in 21 participants. Terminated before completion.

Timeline

12 August 2020

Primary endpoint
7 December 2022

4 January 2023

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	21
Start date	12 August 2020
Primary completion	7 December 2022
Estimated completion	4 January 2023
Sites	1 location across United States

Drugs / interventions tested

• off-the-shelf digital CBT
• adapted digital CBT

Conditions studied

• Sickle Cell Disease — all drugs for Sickle Cell Disease →
• Depression — all drugs for Depression →
• Anxiety — all drugs for Anxiety →

Sponsor

University of Pittsburgh

Who can join

Adults 16 to 35, any sex, with Sickle Cell Disease or Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Frequency of App Use Primary · 4 weeks

A measure of participant engagement. {Number of times the app has been open per week}

Group	Value	95% CI
Off-the-shelf Digital CBT	5.64	± 5.37
Adapted Digital CBT	8.50	± 8.98

Number of Lessons Completed Primary · 4 weeks

A measure of participant engagement. {Total number of lesson completed over the 4 week period}

Group	Value	95% CI
Off-the-shelf Digital CBT	1.27	± 1.62
Adapted Digital CBT	7.1	± 13.94

Number of Interactions (Text/Phone) With Health Coaches Primary · 4 weeks

A measure of participant engagement. {Average number of texts messages sent to their health coach over the treatment period}

Group	Value	95% CI
Off-the-shelf Digital CBT	2.09	± 2.98
Adapted Digital CBT	6.1	± 6.87

Change in Baseline Pain Scale at 4 Weeks Secondary · Baseline vs 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)

Group	Value	95% CI
Off-the-shelf Digital CBT	4.2	± 1.93
Adapted Digital CBT	3.86	± 3.08

Change in Baseline Patient Health Questionnaire (PHQ-9) at 4 Weeks Secondary · Baseline vs 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)

Group	Value	95% CI
Off-the-shelf Digital CBT	10.09	± 4.89
Adapted Digital CBT	6.57	± 4.39

Change in Baseline Generalized Anxiety Disorder Scale (GAD-7) at 4 Weeks Secondary · Baseline vs 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)

Group	Value	95% CI
Off-the-shelf Digital CBT	8.91	± 4.81
Adapted Digital CBT	3.14	± 4.49

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Tailoring a Digital Mental Health Program for Patients With Sickle Cell Disease: Qualitative Study.
   Nikolajski C, O'Brien J, Nardo E, Szigethy E, et al · · 2023 · cited 5× · PMID 37023443 · DOI 10.2196/44216