Trial Outcomes & Findings for Treating Co-Morbid Sleep Difficulties in Veterans With Posttraumatic Stress Disorder (PTSD): A Pilot Study (NCT NCT00734799)

Last Updated: 2015-09-07

Results Overview

Insomnia severity was assessed using the Insomnia Severity Index (ISI). The ISI is a 7-item questionnaire that provides a global measure of perceived insomnia severity. Each item is rated on a 5-point Likert scale, and the total score ranges from 0-28. The following guidelines are recommended for interpreting the total score: 0-7 (no clinical insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia). The ISI was used to determine treatment eligibility, to assess treatment outcome, and to determine clinical significance of study findings. Participants were assessed at baseline and following a 12-week intervention period.

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

12-weeks after Baseline

Results posted on

2015-09-07

Participant Flow

Study participants were recruited between 1/1/2008 and 12/31/2009 using flyers placed throughout the VA hospital and a community Veteran Center, and through letters sent to recently deployed veterans who had enrolled in a VA research registry and who had agreed to be recontacted for participation in VA research.

Of the 93 self-referred prospective study participants, 22 individuals (15 men and 7 women) met study selection criteria, completed baseline procedures, and were subsequently randomized to treatment conditions.

Participant milestones

Participant milestones
Measure	Wait List Usual Care/Wait-List Control	Intervention Sleep Intervention for PTSD (SIP)
Overall Study STARTED	9	13
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treating Co-Morbid Sleep Difficulties in Veterans With Posttraumatic Stress Disorder (PTSD): A Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Wait List n=9 Participants Usual Care/Wait-List Control	Intervention n=13 Participants Sleep Intervention for PTSD (SIP)	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=93 Participants	13 Participants n=4 Participants	21 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Age, Continuous	50.22 years STANDARD_DEVIATION 11.62 • n=93 Participants	47.00 years STANDARD_DEVIATION 9.47 • n=4 Participants	48.61 years STANDARD_DEVIATION 10.42 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	10 Participants n=4 Participants	15 Participants n=27 Participants
Region of Enrollment United States	9 participants n=93 Participants	13 participants n=4 Participants	22 participants n=27 Participants
Insomnia Severity	22.00 units on a scale STANDARD_DEVIATION 3.97 • n=93 Participants	22.77 units on a scale STANDARD_DEVIATION 4.57 • n=4 Participants	22.46 units on a scale STANDARD_DEVIATION 4.25 • n=27 Participants
Sleep Quality	14.33 units on a scale STANDARD_DEVIATION 3.35 • n=93 Participants	14.17 units on a scale STANDARD_DEVIATION 3.27 • n=4 Participants	14.24 units on a scale STANDARD_DEVIATION 3.22 • n=27 Participants
PTSD Symptom Checklist-M	63.44 scores on a scale STANDARD_DEVIATION 11.66 • n=93 Participants	63.08 scores on a scale STANDARD_DEVIATION 12.47 • n=4 Participants	63.23 scores on a scale STANDARD_DEVIATION 11.86 • n=27 Participants
Depression	3.88 scores on a scale STANDARD_DEVIATION 2.08 • n=93 Participants	3.77 scores on a scale STANDARD_DEVIATION 1.74 • n=4 Participants	3.82 scores on a scale STANDARD_DEVIATION 1.84 • n=27 Participants
Sleep-Specific PTSD Symptoms	10.00 scores on a scale STANDARD_DEVIATION 5.29 • n=93 Participants	10.00 scores on a scale STANDARD_DEVIATION 4.10 • n=4 Participants	10.00 scores on a scale STANDARD_DEVIATION 4.50 • n=27 Participants
Nightmare Frequency	0.59 Number of nightmares per night STANDARD_DEVIATION 0.68 • n=93 Participants	0.72 Number of nightmares per night STANDARD_DEVIATION 0.43 • n=4 Participants	0.67 Number of nightmares per night STANDARD_DEVIATION 0.53 • n=27 Participants

PRIMARY outcome

Timeframe: 12-weeks after Baseline

Population: Intent to treat and completed were both reported. Data on completers reported here.

Outcome measures

Outcome measures
Measure	Wait List n=9 Participants Usual Care/Wait-List Control	Intervention n=9 Participants Sleep Intervention for PTSD (SIP)
Insomnia Severity	21.58 ISI Score Standard Error 1.90	12.45 ISI Score Standard Error 1.90

SECONDARY outcome

Timeframe: 12 weeks after Baseline

Nightmare frequency was assessed using an electronic sleep diary. Diary data was collected for a period of 1 week at both baseline and 12 weeks after baseline. The number and severity of nightmares over a 1-week period were obtained using a hand-held computer (PDA) containing an interactive program that automates the collection of subjective sleep data. The PDA device was programmed to elicit daily responses from participants and electronically record multiple days of subjective sleep information, in addition to the number and severity of nightmares for the previous night. Nightmare frequency (number of nightmares per night) was one of five variables collected from electronic sleep diaries.

Outcome measures

Outcome measures
Measure	Wait List n=9 Participants Usual Care/Wait-List Control	Intervention n=9 Participants Sleep Intervention for PTSD (SIP)
Nightmare Frequency	0.83 Nightmare frequency per night Standard Error 0.17	0.51 Nightmare frequency per night Standard Error 0.18

Adverse Events

Wait List

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christi S. Ulmer, PhD

Durham VAMC

Phone: 9192860411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place