Trial · NCT06779149
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Insomnia Symptom Severity | Baseline, during treatment period (weeks 0-8), at the end of the 2-week post-treatment and 6-month follow-up. | Insomnia symptoms will be measured by the Insomnia Severity Index (ISI). The ISI is a self-report questionnaire evaluating seven dimensions of insomnia-severity of sleep onset, sleep maintenance, early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Each item is rated on a 0 to 4 scale and the total score ranges from 0 to 28, with a higher total score suggesting more severe insomnia symptoms. An ISI score \< 8 will be used to define remission. Treatment response will be defined at each assessment as a reduction of 8 points or more on the ISI compared with the baseline score. |
| Secondary | Sleep onset latency from sleep diary | Nightly during 2-week pre-treatment, treatment period (weeks 0-8), 2-week post-treatment and 6-month follow-up. | Mean sleep onset latency per night in minutes from sleep diary. |
| Secondary | Wake after sleep onset from sleep diary | Nightly during 2-week pre-treatment, treatment period (weeks 0-8), 2-week post-treatment and 6-month follow-up. | Mean wake after sleep onset per night in minutes from sleep diary. |
| Secondary | Total sleep time from sleep diary | Nightly during 2-week pre-treatment, treatment period (weeks 0-8), 2-week post-treatment and 6-month follow-up. | Mean total sleep time per night in minutes from sleep diary. |
| Secondary | Sleep efficiency from sleep diary | Nightly during 2-week pre-treatment, treatment period (weeks 0-8), 2-week post-treatment and 6-month follow-up. | Mean sleep efficiency per night in percentage from sleep diary. |
| Secondary | Depressive symptoms | Baseline, at the end of the 2-week post-treatment and 6-month follow-up. | The presence of symptoms of depression will be assessed by the Patient Health Questionnaire-9 (PHQ-9). Scores range from 0 to 27, with scores of 15 and higher suggesting the need for treatment. |
| Secondary | Anxiety symptoms | Baseline, at the end of the 2-week post-treatment and 6-month follow-up. | Anxiety symptom severity will be measured by the Generalised Anxiety Disorder 7-item (GAD-7). Scores range from 0 to 21, with scores of 15 and over suggesting severe anxiety. |
| Secondary | Mental well-being | Baseline, at the end of the 2-week post-treatment and 6-month follow-up. | Mental well-being will be measured by the 5-item World Health Organisation Well-Being Index (WHO-5). Scores range from 0 to 100, with higher scores indicating higher well-being. |
| Secondary | Fatigue | Baseline, at the end of the 2-week post-treatment and 6-month follow-up. | Fatigue severity will be measured by the 9-item Fatigue Severity Scale (FSS). Scores range from 9 to 63 . higher score indicates more severe fatigue and impairment. |
| Secondary | Functional impact of insomnia | Baseline, at the end of the 2-week post-treatment and 6-month follow-up. | Work and Social Adjustment Scale (WSAS) of 5 items will be used to measure how much sleep issues impair ability to function in terms of work, home management, leisure, and relationships. Scores range from 0 to 40. Higher scores indicate more work and social impairment. |
| Secondary | Sleep-related beliefs and attitudes | Baseline, at the end of the 2-week post-treatment and 6-month follow-up. | Sleep-related beliefs and attitudes will be measured by the Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16). Higher scores indicate more dysfunctional beliefs and attitudes about sleep. The total score is calculated from the average score of all the items on the scale and could range from 0 to 10. |
| Other | Cognitive performance | Baseline and at the end of the 2-week post-treatment. | Changes in cognitive performance measured by Cognitive Failures Questionnaire 2.0 (CFQ 2.0) will serve as an exploratory outcome. The CFQ 2.0 is a 15-item questionnaire asking respondents to rate the frequency with which they make minor mistakes (e.g., forgetting to take their keys, calling people by the wrong name). Scores range from 0 to 60, with higher scores indicating greater frequency of cognitive failures. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06779149/registered