The effect of an adapted digital mental health intervention for sickle cell disease on engagement: a pilot randomized controlled trial

Abstract Introduction Despite promising outcomes, lack of engagement and poor adherence are barriers to treating mental health using digital CBT, particularly in minority groups. After conducting guided focus groups, a current mental health app was adapted to be more inclusive for minorities living with SCD. Methods Patients between the ages of 16–35 with SCD who reported experiencing anxiety or depression symptoms were eligible for this study. Once enrolled, participants were randomly assigned to receive one of two versions of a mental health app: 1) the current version designed for the general population or 2) the adapted version. Baseline measures for depression, anxiety, pain, and self-efficacy were completed at the start of the study and again at post-intervention (minimum 4 weeks). Results Compared to baseline, mean scores for pain decreased an average of 3.29 (p = 0.03) on a 10-point scale, self-efficacy improved 3.86 points (p = 0.007) and depression symptoms decreased 5.75 points (p = 0.016) for the group that received the adapted app. On average, control participants engaged with the app 5.64 times while the participants in the experimental group engaged 8.50 times (p = 0.40). Regardless of group assignment, a positive relationship (r = 0.47) was shown between app engagement and a change in depression symptoms (p = 0.042). Discussion Target enrollment for this study sought to enroll 40 participants. However, after difficulties locating qualified participants, enrollment criteria were adjusted to expand the population pool. Regardless of these efforts, the sample size for this study was still smaller than anticipated (n = 21). Additionally, irrespective of group approximately 40% of participants did not engage with the app. However, despite a small sample size and poor engagement, this study 1) demonstrated the feasibility of implementing socially relevant changes into a mental health app and 2) indicated that participants in the intervention group displayed better outcomes and showed trends for greater app interaction. Conclusion These promising results should encourage future researchers to continue exploring ideal adaptations for implementing digital CBT in minority populations. Future studies should also consider implementing post-intervention surveys to help identify common factors relating to a lack of engagement. Trial registration This trial (NCT04587661) was registered on August 12th, 2020.