Trial · NCT01651442
Sequenced Therapies for Comorbid and Primary Insomnias
NCT01651442, Not applicable, Completed, Jack Edinger, PhD; results first posted 2019-08-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sequenced Therapies for Comorbid and Primary Insomnias. Trials, record NCT01651442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01651442
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sequenced Therapies for Comorbid and Primary Insomnias
- NCT number
- NCT01651442
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 211 participants, actual
- Lead sponsor
- Jack Edinger, PhD
- Conditions
- Insomnia Comorbid to Psychiatric Disorder, Primary Insomnia
- Interventions
- Behavioral Insomnia Therapy, Zolpidem, Trazodone, Cognitive Therapy
- First posted
- 2012-07-27
- Last updated
- 2021-03-29
- Results first posted
- 2019-08-28
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index | 6 weeks, 12 weeks, 3 months, 6 months, 9 months & 12 months | The Insomnia Severity Index (ISI) is a self-report questionnaire assessing the nature, severity, and impact of insomnia. Remission is determined to be a score less-than 8. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index | 6 weeks, 12 weeks, 3 months, 6 months, 9 months & 12 months | percent remitted | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index | Non-drug Sleep Therapy 1 | 40.00 | percent remitted | ||
| Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index | Sleep Medication 1 | 34.94 | percent remitted | ||
| Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index | Sleep Medication 1 Plus Non-drug Sleep Therapy 1 | 37.04 | percent remitted | ||
| Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index | Sleep Medication 1 Plus Sleep Medication 2 | 48.15 | percent remitted | ||
| Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index | Non-drug Sleep Therapy 1 Plus Non-drug Sleep Therapy 1 | 44.44 | percent remitted | ||
| Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index | Non-drug Sleep Therapy 1 Plus Sleep Medication 1 | 55.56 | percent remitted |
Source ClinicalTrials.gov
Participant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I Treatment | STARTED | Non-drug Sleep Therapy 1 | 104 | |
| Phase I Treatment | STARTED | Sleep Medication 1 | 107 | |
| Phase I Treatment | STARTED | Non-drug Sleep Therapy 2 Following Non-drug Sleep Therapy 1 | 0 | |
| Phase I Treatment | STARTED | Sleep Medication 2 Following Sleep Medication 1 | 0 | |
| Phase I Treatment | STARTED | Non-drug Sleep Therapy 1 Following Sleep Medication 1 | 0 | |
| Phase I Treatment | STARTED | Sleep Medication 1 Following Non-drug Sleep Therapy 1 | 0 | |
| Phase I Treatment | COMPLETED | Non-drug Sleep Therapy 1 | 88 | |
| Phase I Treatment | COMPLETED | Sleep Medication 1 | 80 | |
| Phase I Treatment | COMPLETED | Non-drug Sleep Therapy 2 Following Non-drug Sleep Therapy 1 | 0 | |
| Phase I Treatment | COMPLETED | Sleep Medication 2 Following Sleep Medication 1 | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Non-drug Sleep Therapy 1 | 0 | 131 |
| Total, all-cause mortality | Sleep Medication 1 | 0 | 134 |
| Total, all-cause mortality | Non-drug Sleep Therapy 2 | 0 | 27 |
| Total, all-cause mortality | Sleep Medication 2 | 0 | 27 |
| Total, other adverse events | Non-drug Sleep Therapy 1 | 0 | 131 |
| Total, other adverse events | Sleep Medication 1 | 0 | 134 |
| Total, other adverse events | Non-drug Sleep Therapy 2 | 0 | 27 |
| Total, other adverse events | Sleep Medication 2 | 0 | 27 |
| Total, serious adverse events | Non-drug Sleep Therapy 1 | 0 | 131 |
| Total, serious adverse events | Sleep Medication 1 | 0 | 134 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 |
|---|---|---|---|---|---|---|
| R01MH091053 | 2/2-Sequenced Therapies for Comorbid and Primary Insomnias | MORIN, CHARLES M. | LAVAL UNIVERSITY | NATIONAL INSTITUTE OF MENTAL HEALTH | 2011 to 2015 | NIH RePORTER |
| R01MH091075 | 1/2-Sequenced Therapies for Comorbid and Primary Insomnias | EDINGER, JACK D | NATIONAL JEWISH HEALTH | NATIONAL INSTITUTE OF MENTAL HEALTH | 2011 to 2015 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01651442
GET https://conductscience.org/api/trials/v1/NCT01651442/flow?page=2