Trial · NCT07899957
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Insomnia Severity Index | Day 0 ，Week 1 ，Week 2 ，Week 3，Week 4 | Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity. |
| Secondary | Pittsburgh Sleep Quality Index | Day 0 ，Week 1 ，Week 2 ，Week 3，Week 4 | Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). Total score ranges from 0 to 21; higher scores indicate poorer sleep quality. |
| Secondary | Sleep Diary | Day 0 ，Week 1 ，Week 2 | Bedtime, sleep onset latency, number and duration of nocturnal awakenings, early morning awakening, total sleep time, sleep efficiency, and morning mental status were recorded. |
| Secondary | 17-item Hamilton Depression Rating Scale | Day 0, Week 4, Week 8 | The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-rated scale for assessing the severity of depressive symptoms. It contains 17 items, with a total score ranging from 0 to 52. Higher scores indicate more severe depressive symptoms. |
| Secondary | Hamilton Anxiety Scale | Day 0, Week 4, Week 8 | The Hamilton Anxiety Scale (HAMA) is a 14-item clinician-rated scale to assess the severity of anxiety symptoms. Each item is scored from 0 to 4. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms. |
| Secondary | Fatigue Severity Scale | Day 0, Week 4, Week 8 | The Fatigue Severity Scale (FSS) is a 9-item self-reported questionnaire for assessing fatigue severity. Each item is scored on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). The total score ranges from 9 to 63, with higher scores indicating more severe fatigue. |
| Secondary | Epworth Sleepiness Scale | Day 0, Week 4, Week 8 | The Epworth Sleepiness Scale (ESS) is an 8-item self-reported questionnaire to assess the degree of daytime sleepiness. Each item is scored from 0 to 3. The total score ranges from 0 to 24, with higher scores indicating more severe daytime sleepiness. |
| Secondary | Drug Craving Visual Analogue Scale | Day 0, Week 4, Week 8 | Drug craving was assessed using the Visual Analogue Scale (VAS). The scale is a single-item self-reported measure for evaluating the intensity of drug craving. Scores range from 0 to 100 (or 0-10), with higher scores indicating stronger drug craving. |
| Secondary | Brief Substance Craving Scale | Day 0, Week 4, Week 8 | Brief Substance Craving Scale (BSCS). Score range: 0-12. Higher scores indicate greater substance craving (worse outcome). |
| Secondary | Chinese Version of the Stimulant Relapse Risk Scale | Day 0, Week 4, Week 8 | Chinese Version of the Stimulant Relapse Risk Scale (SRRS-C). Score range: 18-72. Higher scores indicate higher stimulant relapse risk (worse outcome). |
| Secondary | Heart Rate Variability | Day 0 ，Week 2 | Heart rate variability (HRV) was recorded to assess autonomic nervous system function. Time-domain and frequency-domain parameters were extracted, including SDNN, RMSSD, LF, HF and LF/HF ratio. Higher HRV values indicate better vagal modulation and autonomic flexibility. |
| Secondary | sleep efficiency | Day 0 ，Week 1，Week 2 | The proportion of time in bed actually spent asleep, usually calculated as Total Sleep Time divided by Time in Bed, multiplied by 100%. |
| Secondary | total sleep time | Day 0 ，Week 1，Week 2 | The total duration (in minutes) scored as sleep by the device or algorithm during the primary sleep period. |
| Secondary | sleep onset latency | Day 0 ，Week 1，Week 2 | The duration from sleep preparation (such as getting into bed and turning off the lights) to sleep onset. |
| Secondary | sleep onset latency after awakening | Day 0 ，Week 1，Week 2 | The total minutes classified as wakefulness between the time of falling asleep and the final awakening. |
| Secondary | Sleep Period | Day 0 ，Week 1，Week 2 | The total time interval between sleep onset and the final wake-up time (sleep offset). |
| Secondary | Night Waking Frequency | Day 0 ，Week 1，Week 2 | Number of night awakenings during sleep period. Unit: count. Higher values indicate worse sleep. |
| Secondary | Night Waking Duration | Day 0 ，Week 1，Week 2 | Total duration of night awakenings during sleep period. Unit: minutes. Higher values indicate worse sleep. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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