Clinical Trial Radar

Time to Reliable Recovery

According to the standard definition of the IAPT (Improving Access to Psychological Therapies) system (El Baou et al., 2023; Gyani et al., 2013), reliable recovery requires meeting both of the following conditions simultaneously: (1) Reliable improvement: a decrease in PHQ-9 score of ≥6 points, or a decrease in GAD-7 score of ≥4 points, compared to baseline; (2) Symptoms below clinical thresholds: PHQ-9 \< 10 and GAD-7 \< 8. Time to reliable recovery is defined as the time from randomization to the first point at which both of the above criteria are met.

at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention

Loss of diagnosis

Loss of diagnosis, based on the results of the MINI Structured Interview, is defined as the time at which, during follow-up, a person no longer meets the criteria for any mood disorder diagnosis for the first time. Chinese version of the Mini International Neuropsychiatric Interview (MINI) is used. The MINI is a brief, structured diagnostic interview that is simple, quick to administer, and reliable. Previous research has shown that the MINI has good concordance with the Structured Clinical Interview for DSM (SCID-P) and the Composite International Diagnostic Interview (CIDI). The MINI demonstrates strong validity and reliability, as well as high inter-rater reliability.

at baseline (T0), at post-intervention (T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention

Time to relapse

Time to relapse is defined as the time from achieving reliable recovery to the point at which, at any follow-up assessment, either of the following criteria is met: a PHQ-9 score ≥ 10 or a GAD-7 score ≥ 8

at baseline (T0), at post-intervention (T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention

Rate of reliable improvement

Reliable improvement is a decrease in PHQ-9 score of ≥6 points, or a decrease in GAD-7 score of ≥4 points, compared to baseline. Rate of reliable improvement is the former divided by time.

at baseline (T0), and at 12(T5), and 24(T7) months after the intervention

Rate of reliable recovery

Reliable recovery requires meeting both of the following conditions simultaneously: (1) Reliable improvement (2) Symptoms below clinical thresholds: PHQ-9 \< 10 and GAD-7 \< 8. Rate of reliable recovery is that divided by time.

at baseline (T0), and at 12(T5), and 24(T7) months after the intervention

Deterioration rate

Deterioration is defined according to IAPT criteria as a clinically significant worsening from baseline, operationalized as: PHQ-9 increase ≥ 6 points, or GAD-7 increase ≥ 4 points. Deterioration rate is deterioration divided by time.

at baseline (T0), and at 12(T5), and 24(T7) months after the intervention

Health related quality of life

Using the EQ-5D-5L to measure, obtain health utility index and its changes over time, for estimating quality-adjusted life years (QALYs).The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) is a standardized measure of health-related quality of life. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale ranging from 1 (no problems) to 5 (extreme problems), describing the respondent's health status on the day of assessment. In addition, the EQ-5D-5L includes a visual analogue scale (EQ-VAS), on which participants rate their overall health from 0 (the worst health you can imagine) to 100 (the best health you can imagine)

at baseline (T0), at post-intervention (T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention

Cost-effectiveness

The Treatment Inventory of Costs in Patients with Psychiatric Disorders (TIC-P) is designed to systematically assess both the direct medical costs (e.g., outpatient visits, hospitalizations, medication expenses) and indirect productivity losses (e.g., absenteeism, reduced work efficiency) associated with psychiatric disorders in adults. It includes a combination of quantitative and qualitative items and collects data through self-report by patients to evaluate the economic burden related to mental illness. Structured with a multidimensional framework, the TIC-P covers the frequency of healthcare resource utilization, cost accounting, and the impact on social functioning, enabling a comprehensive estimation of the economic costs associated with mental health interventions. The "cost" part of cost-effectiveness is measures with TIC-P, whereas the "effectiveness" part is the 24 months rate of reliable recovery.

at baseline (T0), at post-intervention (T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention

Cost-utility

Cost is measured with TIC-P ; utility - QALYs derived from the EQ-5D-5L conversion.

at baseline (T0), at post-intervention (T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention

Severity of depressive symptoms

Depressive symptoms measured using PHQ-9, focusing on how depression change over time.

at baseline(T0), at week3(T1), at week5(T2), at post-intervention(T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention.

Severity of anxiety symptoms

Anxiety symptoms measured using GAD-7, focusing on how anxiety symptoms change over time.

at baseline (T0), at week 3 (T1), at week 5 (T2), at post-intervention (T3), and at 6 (T4), 12 (T5), 18 (T6), and 24 (T7) months after the intervention.

Severity of insomnia symptoms

Insomnia symptoms measured using ISI, focusing on how insomnia symptoms change over time.

at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 6(T4), 12(T5), 18(T6), and 24(T7) months after the intervention

Severity of somatic symptoms

Somatic symptoms measured using SSS-8, focusing on how somatic symptoms change over time.

at baseline (T0), at week 3 (T1), at week 5 (T2), at post-intervention (T3), and at 6 (T4), 12 (T5), 18 (T6), and 24 (T7) months after the intervention.