Trial · NCT00393874

Efficacy of Sleep Interventions for Posttraumatic Stress Disorder (PTSD)

NCT00393874, Not applicable, Completed, University of Pittsburgh; results first posted 2016-10-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy of Sleep Interventions for Posttraumatic Stress Disorder (PTSD). Trials, record NCT00393874. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00393874

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy of Sleep Interventions for Posttraumatic Stress Disorder (PTSD)
NCT number: NCT00393874
Status: Completed
Phases: Not applicable
Enrollment: 50 participants, actual
Lead sponsor: University of Pittsburgh
Conditions: Anxiety Disorders, Mood Disorders, Insomnia, Nightmares
Interventions: Behavioral Sleep Intervention, Prazosin, Placebo
First posted: 2006-10-30
Last updated: 2016-10-24
Results first posted: 2016-10-24

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Insomnia Severity Index	Screening, Post, and Follow-up	Self-report measures of insomnia severity. Scores range from 0 to 28, with higher scores indicated more severe insomnia. A score \< 8 is considered to reflect no significant insomnia.
Primary	Sleep Diary Measures	baseline and post	Sleep diary SE, nightmare frequency Sleep diary sleep efficiency can range from 0 to 100%, and typically varies between 50% and 95%. Higher % values reflect greater sleep consolidation, i.e., greater ratio of time asleep/time in bed. Nightmare frequency varies between 0 and no upper limit is provided. Greater frequency of nightmares reflects greater nightmare severity.
Primary	PSG Composite Measure	Baseline sleep study and post sleep study	Sleep Efficiency (SE) is the ratio of total time spent asleep over total time spent in bed. For PSG studies, (SE) typically vary between 50% and 95%. Greater values indicated more consolidated sleep.
Primary	PSQI	Baseline, post, 4 months post-treatment	Self-report sleep quality measure. Scores range between 0 and 21, with higher scores reflecting poor sleep quality. A score of \< or = to 5 reflects good sleep quality.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Insomnia Severity Index	Screening, Post, and Follow-up	For the medication arm, 18 participants completed ISI at screening, 15 at post, and 12 at follow-up. For the Behavioral arm, 17 participants completed ISI at screening, 13 at post, and 12 at follow-up. For the placebo arm, 15 participants completed ISI at screening, 13 at post, and 11 at follow-up.	units on a scale	MEAN
PRIMARY	Sleep Diary Measures	baseline and post	For the medication arm, 15 participants completed the sleep diary (SD) at baseline and 13 returned a SD post treatment. For the Behavioral arm, 15 participants completed the SD at baseline, and 12 returned it at follow-up. For the placebo arm, 12 participants completed the diary at baseline and 10 returned one at follow-up.	units on a scale	MEAN
PRIMARY	PSG Composite Measure	Baseline sleep study and post sleep study	For the medication arm, 18 participants completed a PSG study at baseline and 13 completed a PSG post treatment. For the Behavioral arm, 17 participants completed a PSG at baseline and 12 completed a PSG post-treatment. For the placebo arm, 15 participants completed a PSG at baseline and 12 completed a PSG post-treatment.	percentage of time asleep vs time in bed	MEAN
PRIMARY	PSQI	Baseline, post, 4 months post-treatment	For the medication arm, 18 participants completed PSQI at screening, 14 at post, and 12 at follow-up. For the Behavioral arm, 17 participants completed ISI at screening, 13 at post, and 12 at follow-up. For the placebo arm, 15 participants completed ISI at screening, 13 at post, and 11 at follow-up.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Insomnia Severity Index	Medication	Screening	16.4	Standard Deviation 4.4	units on a scale
Insomnia Severity Index	Behavioral	Screening	16.5	Standard Deviation 4.0	units on a scale
Insomnia Severity Index	Placebo	Screening	14.8	Standard Deviation 3.7	units on a scale
Insomnia Severity Index	Medication	Post	9.3	Standard Deviation 7.2	units on a scale
Insomnia Severity Index	Behavioral	Post	6.8	Standard Deviation 5.0	units on a scale
Insomnia Severity Index	Placebo	Post	11.8	Standard Deviation 5.0	units on a scale
Insomnia Severity Index	Medication	Follow-up	7.0	Standard Deviation 4.7	units on a scale
Insomnia Severity Index	Behavioral	Follow-up	5.5	Standard Deviation 5.0	units on a scale
Insomnia Severity Index	Placebo	Follow-up	8.7	Standard Deviation 5.1	units on a scale
Sleep Diary Measures	Medication	SE Pre Treatment	84.5	Standard Deviation 11.8	units on a scale

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Medication	18
Overall Study	STARTED	Behavioral	17
Overall Study	STARTED	Placebo	15
Overall Study	COMPLETED	Medication	15
Overall Study	COMPLETED	Behavioral	13
Overall Study	COMPLETED	Placebo	13
Overall Study	NOT COMPLETED	Medication	3
Overall Study	NOT COMPLETED	Behavioral	4
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events3

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
other	Headache, drowsiness	Nervous system disorders	Medication	4	15	4
other	Headache, drowsiness	Nervous system disorders	Behavioral	3	13	3
other	Headache, drowsiness	Nervous system disorders	Placebo	2	13

Source ClinicalTrials.gov

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Medication
Total, all-cause mortality	Behavioral
Total, all-cause mortality	Placebo
Total, other adverse events	Medication	4	15
Total, other adverse events	Behavioral	3	13
Total, other adverse events	Placebo	2	13
Total, serious adverse events	Medication	0	15
Total, serious adverse events	Behavioral	0	13
Total, serious adverse events	Placebo	0	13

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22281448	DERIVED

Source PubMed

Grants0

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.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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

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