Trial results for a study investigating therapist-guided smartphone-delivered Cognitive Behavioral Therapy (CBT) for Major Depressive Disorder were posted on ClinicalTrials.gov on 2025-05-28. The study, which enrolled 28 participants, reported significant reductions in depression and functional impairment scores.
Background
Major Depressive Disorder (MDD) is a common and serious mood disorder that negatively affects how a person feels, thinks, and acts. Traditional treatments often involve psychotherapy, pharmacotherapy, or a combination of both. However, barriers such as access to care, stigma, and cost can limit treatment uptake and adherence. Digital health interventions, particularly smartphone-delivered therapies, offer a promising avenue to increase accessibility and engagement. Combining these digital tools with therapist guidance aims to leverage technology while retaining the benefits of human support, potentially improving outcomes for individuals with MDD.
Trial design
This completed study, designated as Phase NA, enrolled 28 participants with Major Depressive Disorder. The trial investigated a therapist-guided smartphone application designed to deliver Cognitive Behavioral Therapy (CBT). Researchers aimed to assess the usability of the new treatment, participant satisfaction, and its potential to lower depressive symptoms. The intervention involved a smartphone app combined with short weekly virtual appointments with a therapist.
Key results
The trial reported on several usability, satisfaction, and symptom-related outcomes:
- Drop-Out Rates: 2 participants dropped out of the study, with 26 participants completing the intervention.
- Patient Satisfaction (as Measured by the CSQ-8): Mean scores for the "Therapist-guided Smartphone-delivered CBT" group were 26.3 (Standard Deviation 4.0) and 27.2 (Standard Deviation 3.3) on a scale.
- Treatment Credibility (as Measured by the CEQ): Mean scores were 18.9 (Standard Deviation 3.1) and 19.3 (Standard Deviation 3.8) on a scale.
- Outcome Expectancy (as Measured by the CEQ): Mean scores were 13.8 (Standard Deviation 3.3) and 15.0 (Standard Deviation 5.4) on a scale.
- App Rating (as Measured by the uMARS): Mean ratings were 3.6 (Standard Deviation 0.6), 4.5 (Standard Deviation 0.6), 4.6 (Standard Deviation 0.5), and 4.6 (Standard Deviation 0.4) on a scale.
Key analyses revealed:
- A mixed models analysis for the change in Patient Satisfaction (CSQ-8) between midpoint (week 4) and end-of-treatment (week 8) showed a mean difference of 1.0308 (95% CI: -0.09883 to 2.1605) with a p-value of 0.0719, indicating no significant difference.
- For the change in Treatment Credibility (CEQ) between baseline (week 0) and midpoint (week 4), the mean difference was 0.4296 (95% CI: -1.3884 to 2.2475) with a p-value of 0.6316, also indicating no significant difference.
- The change in Outcome Expectancy (CEQ) between baseline (week 0) and midpoint (week 4) had a mean difference of 1.1512 (95% CI: -0.7422 to 3.0446) with a p-value of 0.2225, showing no significant difference.
- A Wilcoxon (Mann-Whitney) analysis for treatment utilization between midpoint (week 4) and end of treatment (week 8) yielded a Wilcoxon Z of 0.2712 and a p-value of 0.7873, indicating no significant difference.
- However, a mixed models analysis showed a significant reduction in HAM-D total scores between baseline (week 0) and end of treatment (week 8), with a mean difference of -7.8424 (95% CI: -10.4944 to -5.1903) and a p-value of 0.0001.
- Similarly, there was a significant reduction in WSAS total scores between baseline (week 0) and end of treatment (week 8), with a mean difference of -9.9409 (95% CI: -13.5043 to -6.3776) and a p-value of 0.0001.
What this means
The results suggest that therapist-guided smartphone-delivered CBT may be an effective intervention for individuals with Major Depressive Disorder. The significant reductions in HAM-D and WSAS total scores from baseline to the end of treatment indicate that the intervention successfully lowered depressive symptoms and improved functional impairment. While specific measures of patient satisfaction, treatment credibility, and outcome expectancy did not show statistically significant changes over the course of the study, the overall app ratings were generally positive. The low dropout rate of 2 participants out of 28 also points to good feasibility and acceptability of this digital therapeutic approach, potentially offering an accessible treatment option for MDD.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05386329, titled "Therapist-Guided Smartphone-Delivered CBT for MDD", were posted on 2025-05-28 on clinicaltrials.gov.