Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints
NCT06032377, Not applicable, Recruiting, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints | ClinicalTrials.gov |
| NCT number | NCT06032377 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 275 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal | ClinicalTrials.gov |
| Conditions | Insomnia | ClinicalTrials.gov |
| Interventions | cognitive behavioral therapy for sleep, anxiety, and depression, education about healthy nutrition habits and communication in older age | ClinicalTrials.gov |
| First posted | 2023-09-13 | ClinicalTrials.gov |
| Last updated | 2026-03-18 | ClinicalTrials.gov |
Registered outcomes 38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Insomnia severity index | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Insomnia Severity Index. ISI range from 0 to 28, higher score means more severe insomnia symptoms. | ClinicalTrials.gov |
| Primary | Subjective cognitive impairment based on cognitive failure questionnaire | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Cognitive Failure Questionnaire (CFQ) total score as well as number of items with a score ≥ 3. The CFQ comprises 25 items and total score corresponds to the sum of all completed items, total score range from 0 to 100. | ClinicalTrials.gov |
| Primary | Objective cognitive performance based on a composite score for executive functions from the CANTAB | At baseline and at 24 weeks after the start of the intervention | Change in the Cambridge Neuropsychological Test Automated Battery (CANTAB) executive functions composite score (Intra-Extra Dimensional Set Shift \[IED\] and Stocking of Cambridge \[SOC\], ranging from 0 to 100 with higher scores reflecting poorer executive functions. | ClinicalTrials.gov |
| Primary | Geriatric anxiety index | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Geriatric anxiety index. GAI scores range from 0 to 20 and higher scores mean more severe anxiety symptoms. | ClinicalTrials.gov |
| Primary | Geriatric depression scale | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Geriatric depression scale. GDS scores range from 0 to 15, higher scores mean more severe depression symptoms. | ClinicalTrials.gov |
| Secondary | Sleep quality based on the Pittsburgh sleep quality index | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Pittsburgh sleep quality index. PSQI scores range from 0 to 21, higher scores mean worse sleep quality. | ClinicalTrials.gov |
| Secondary | Objective sleep measures based on actigraphy: Sleep Efficiency | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Sleep Efficiency (SE) from actigraphs. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency. | ClinicalTrials.gov |
| Secondary | Objective sleep measures based on actigraphy: Sleep Latency | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Sleep Latency (SL) from actigraphs. Sleep latency in minutes, greater values mean longer time to fall asleep. | ClinicalTrials.gov |
| Secondary | Objective sleep measures based on actigraphy: Total Sleep Time | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Total Sleep Time (TST) from actigraphs. Total Sleep Time in minutes, greater values mean longer time spent asleep. | ClinicalTrials.gov |
| Secondary | Objective sleep measures based on actigraphy: Wake After Sleep Onset | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Wake After Sleep Onset (WASO) from actigraphs. Wake After Sleep Onset in minutes, greater values mean longer time spent awake. | ClinicalTrials.gov |
| Secondary | Objective sleep measures based on EEG: Sleep Efficiency | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Sleep Efficiency (SE) from EEG. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency. | ClinicalTrials.gov |
| Secondary | Objective sleep measures based on EEG: Sleep Latency | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Sleep Latency (SL) from EEG. Sleep latency in minutes, greater values mean longer time to fall asleep | ClinicalTrials.gov |
| Secondary | Objective sleep measures based on EEG: Total Sleep Time | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Total Sleep Time (TST) from EEG. Total Sleep Time in minutes, greater values mean longer time spent asleep. | ClinicalTrials.gov |
| Secondary | Objective sleep measures based on EEG: Wake After Sleep Onset | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Wake After Sleep Onset (WASO) from EEG. Wake After Sleep Onset in minutes, greater values mean longer time spent awake. | ClinicalTrials.gov |
| Secondary | Objective sleep measures based on EEG: Slow Wave Activity | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Slow Wave Activity (SWA) power density from EEG. | ClinicalTrials.gov |
| Secondary | Objective sleep measures based on EEG: Slow Wave Sleep | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Slow Wave Sleep (SWS) from EEG. Slow Wave Sleep in minutes, greater values mean longer time spent in Slow Wave Sleep. | ClinicalTrials.gov |
| Secondary | Subjective sleep measures based on sleep diaries: Sleep Efficiency | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Sleep Efficiency (SE) from sleep diaries. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency. | ClinicalTrials.gov |
| Secondary | Subjective sleep measures based on sleep diaries: Sleep Latency | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Sleep Latency (SL) from sleep diaries. Sleep latency in minutes, greater values mean longer time to fall asleep. | ClinicalTrials.gov |
| Secondary | Subjective sleep measures based on sleep diaries: Total Sleep Time | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Total Sleep Time (TST) from sleep diaries. Total Sleep Time in minutes, greater values mean longer time spent asleep. | ClinicalTrials.gov |
| Secondary | Subjective sleep measures based on sleep diaries: Wake After Sleep Onset | At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention | Change in Wake After Sleep Onset (WASO) from sleep diaries. Wake After Sleep Onset in minutes, greater values mean longer time spent awake. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 13
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Intra/Extra Dimensional Set Shift | Primary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Paired Associate Learning | Secondary outcome | ConductCognition |
| Pattern Recognition Memory | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Rapid Visual Information Processing | Secondary outcome | ConductCognition |
| Short Story Recall | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)