Effectiveness of Cognitive Behavioral Therapy Provided Through a Web Application for Subthreshold Depression, Subthreshold Insomnia, and Subthreshold Panic: Open-Labeled 6-Arm Randomized Clinical Trial Pilot Study.

Background: A common definition of "subthreshold" is that the diagnostic threshold is not met but the individuals are not asymptomatic. Some symptoms are present, causing significant difficulty in functioning and negatively impacting quality of life. Despite the attention given to subthreshold symptoms and the interventions for subthreshold symptoms being efficient in preventing the transition to psychiatric disease in primary care, reports on specific interventions are insufficient.

Objective: This study aimed to verify the effectiveness of internet-delivered cognitive behavioral therapy (ICBT) for subthreshold depression (SD), subthreshold insomnia (SI), and subthreshold panic (SP). Additionally, this study aimed to explore the minimally important change (MIC) of each subthreshold group's effectiveness outcome.

Methods: Participants aged 18-70 years from internet research monitors were categorized into SD, SI, and SP groups based on screening assessment. They were randomly assigned to intervention or control groups within each subthreshold symptom. The intervention groups worked on 4 weeks of nonguided ICBT ("Mentre"), while the control groups worked on a sham app. The primary outcome was the score change from screening (T1) to 4-week follow-up (T4) using the Center for Epidemiologic Studies Depression Scale (CESD) in the SD group, the Pittsburgh Sleep Quality Index (PSQI) in the SI group, and the Panic and Agoraphobia Scale (PAS) in the SP group. Secondary outcomes were score changes in the Generalized Anxiety Disorder-7 (GAD-7) scale, the Patient Health Questionnaire 9 (PHQ-9), the CESD, the PSQI, and the PAS, except the primary outcome in each group. Secondary outcomes were analyzed using complete-case analysis and repeated-measures ANOVA. Additionally, the MIC in the primary endpoint for each group was also calculated as an exploratory outcome.

Results: The SD, SP, and SI groups contained 846, 597, and 1106 participants, respectively. In the SD group, the difference in the CESD score change from baseline to follow-up between the intervention and control groups was significant (difference=0.52, 95% CI 1.29-4.66, P<.001). In the SI group, the difference in the PSQI score change was also significant (difference=0.53, 95% CI 0.11-0.94, P=.01). However, in the SP group, the difference in the PAS score change was not significant (difference=0.07, 95% CI -2.00 to 2.15, P=.94).

Conclusions: Our ICBT program Mentre contributes to the improvement of SI and SD. This suggests that nonguided ICBT may be effective in preventing SI and SD from progressing to the full threshold. However, appropriate definitions of subthreshold symptoms are necessary. In particular, it is difficult to define SP, and further research that considers the specific factors of each subthreshold symptom is necessary to accumulate evidence.

Trial registration: University Hospital Medical Information Network (UMIN) UMIN000051280; https://tinyurl.com/2wyahhe3.