A Multi-Component Cognitive-Behavioral Intervention for Sleep

Disturbance in Veterans with PTSD: A Pilot Study

Christi S. Ulmer, Ph.D.1,2; Jack D. Edinger, Ph.D.1,2; Patrick S. Calhoun, Ph.D.2,3
1
Durham Veterans Affairs Medical Center, Durham, NC; 2Department of Psychiatry and Behavioral Sciences, Duke University
Medical Center, Durham, NC; 3VISN 6 Mental Illness Research, Education, and Clinical Center S, Durham, NC

Study Objectives: A significant portion of US military person- treatment effect sizes for all sleep diary outcomes, and very
nel are returning from deployment with trauma-related sleep large treatment effects for insomnia severity, sleep quality, and
disturbance, and disrupted sleep has been proposed as a PTSD symptoms.
S C I E N T I F I C I N V E S T I G AT I O N S

mechanism for the development of medical conditions in those Conclusions: Findings demonstrate that an intervention tar-
with posttraumatic stress disorder (PTSD). Although individu- geting trauma-specific sleep disturbance produces large short-
als with PTSD may realize improved sleep with either PTSD term effects, including substantial reductions in PTSD symp-
treatment or CBT for insomnia, many continue to experience toms and insomnia severity. Future research should focus on
residual sleep difficulties. Newly developed interventions de- the optimal approach to the treatment of comorbid PTSD and
signed to address nightmares are effective to this end, but sleep disturbance in terms of sequencing, and should assure
often do not fully remove all aspects of PTSD-related sleep that sleep-focused interventions are available and acceptable
difficulties when used in isolation. A combined intervention in- to our younger veterans, who were more likely to drop out of
volving both a nightmare-specific intervention and CBT for in- treatment.
somnia may lead to more marked reductions in PTSD-related Keywords: PTSD, insomnia, nightmares, imagery rehearsal
sleep disturbances. therapy, nightmare rescripting, cognitive-behavioral therapy for
Methods: Twenty-two veterans meeting criteria for PTSD insomnia, exposure, sleep quality
were enrolled in the study. A combined intervention comprised Citation: Ulmer CS; Edinger JD; Calhoun PS. A multi-com-
of CBT for insomnia and imagery rehearsal therapy was evalu- ponent cognitive-behavioral intervention for sleep distur-
ated against a usual care comparison group. bance in veterans with PTSD: a pilot study. J Clin Sleep Med
Results: Intent-to-treat analyses revealed medium to large 2011;7(1):57-68.

M ore than 1.6 million US military personnel deployed to

Afghanistan and Iraq from 2001 to 2008. Approximately
21% of the soldiers in the wars in Iraq (Operation Iraqi Free-
BRIEF SUMMARY
Current Knowledge/Study Rationale: CBT for Insomnia results in
improved sleep across a variety of populations.  Imagery Rehearsal
dom: OIF) and Afghanistan (Operation Enduring Freedom: Therapy (IRT) has been shown effective in those with post-traumatic
OEF) will receive a diagnosis of PTSD following their service.1 stress disorder (PTSD).  Addressing the sleep complaints of Veterans
Most of these veterans (70% to 91%) are likely to report dif- with PTSD may be optimized by combining CBT for Insomnia with IRT
ficulty initiating or maintaining sleep.2 Still others, who do not for nightmares.
meet full diagnostic criteria for PTSD, will endorse sleep distur- Study Impact: Pilot study findings suggest that this combined interven-
bance. All of these veterans will add to the existing population tion is promising for improving sleep and reducing PTSD symptoms in
of veterans from earlier eras of military service, who continue Veterans with PTSD.  Given the increasing number of military personnel
to experience trauma-related sleep disturbance. Although find- returning from deployment with PTSD and trauma-related sleep distur-
bance, trauma-specific sleep interventions are imminently needed.
ings have been mixed in terms of objective evidence of sleep
disturbance in those with PTSD, recent studies have bolstered
the evidence that persons with PTSD have objectively measured Insomnia and nightmares are the two primary complaints
sleep complaints3,4 that warrant treatment attention. Whereas of veterans with PTSD. Cognitive-behavioral therapy (CBT)
standard cognitive-behavioral PTSD treatment may facilitate for insomnia enjoys substantial empirical support for treating
improved sleep quality,5 evidence suggests that as many of primary and comorbid insomnia.8,9 In veterans, a secondary
50% of patients who achieve PTSD remission following treat- analysis of data acquired from a larger treatment study showed
ment continue to experience residual insomnia.6,7 Given the that the subset with PTSD displayed pre-to-post treatment re-
burden of PTSD on our veterans and the systems responsible ductions in sleep onset latency and wake after sleep onset, and
for providing their health care, interventions addressing their increased sleep efficiency and sleep quality in response to CBT
sleep disturbances are vitally important for ameliorating current for insomnia.10 PTSD patients showed a better overall sub-
distress and preventing the consequent adverse health sequelae jective and objective response to CBT than they did to sleep
in the longer term. hygiene education. In spite of these positive outcomes, PTSD

57 Journal of Clinical Sleep Medicine, Vol. 7, No. 1, 2011

CS Ulmer, JD Edinger, PS Calhoun et al
patients did not remit from insomnia following treatment in ei- a multi-component cognitive-behavioral sleep intervention for
ther treatment condition. The findings of these secondary analy- PTSD (SIP) using a randomized trial design. Our secondary pur-
ses suggest that, although CBT for insomnia may be helpful for pose was to compare the intervention to usual care in terms of
veterans with PTSD, interventions targeting the specific sleep differential symptoms of sleep disturbance at post-intervention.
concerns of this population are needed. We hypothesized that the combined effects of CBT for insomnia
Although most individuals with PTSD are likely to experi- and IRT for nightmares would produce significantly greater im-
ence insomnia, trauma-related sleep disturbance diverges from provements in sleep disturbance than usual care alone.
classic insomnia by virtue of several distinguishing factors.
While insomniacs look favorably upon sleep, those with trau- METHODS
ma-related sleep disturbance are likely to view sleep as a neces-
sary evil. Most veterans with PTSD experience hypervigilance;
the need to remain aware of their surroundings at all times. Study Design
Sleeping is an inherently contradictory experience to vigilance. This study used a randomized parallel group experimental
Thus, veterans with PTSD are often sleep-avoidant, and this design. Participants were randomly assigned to either the inter-
avoidance is further reinforced by the aversiveness of the night- vention condition or a usual care condition, and were informed
mares that accompany sleep. Finally, the sleep architecture of that the purpose of the study was to test the effectiveness of an
individuals with PTSD differs from both normal sleepers and intervention for improving sleep disturbance in veterans with
insomniacs, particularly with respect to the duration and onset PTSD. The study was approved by the institutional review
of REM sleep.3 Taken together, these observations suggest that board of our VA medical center, and all who enrolled provided
trauma-related sleep disturbance is an inherently different and written informed consent.
more complex phenomenon than insomnia that is unlikely to
remit using existing insomnia treatment approaches. Participants
Several studies have presented data on behavioral treatments Study participants were recruited between 1/1/2008 and
for nightmares in PTSD populations. Imagery rehearsal therapy 12/31/2009 using flyers placed throughout the VA hospital
(IRT), first presented in the empirical literature by Kellner and and a community Veteran Center, and through letters sent to
colleagues,11,12 was designed to reduce nightmare frequency recently deployed veterans who had enrolled in a VA research
and severity using “rescripting” of nightmares. Krakow and registry and who had agreed to be recontacted for participation
colleagues presented a more intensive conceptualization of this in VA research. To be considered for the study, veterans had
protocol in which nightmares are described as learned behav- to: (1) provide written informed consent; (2) meet DSM-IV-
iors that can be relearned through the use of enhanced imagery R criteria for a diagnosis of PTSD; (3) screen positive for an
skills.13 Imagery rehearsal therapy has been empirically validat- insomnia disorder on the Duke Structured Sleep Interview for
ed and has produced favorable findings in terms of nightmares Sleep Disorders; (4) score > 14 on the Insomnia Severity Index;
and PTSD symptoms in female sexual assault victims14 and de- and endorse nightmares on the PCL-M or the CAPs. Patients
ployed US army soldiers.15 IRT was combined with CBT for who screened positive on the DSISD for symptoms of sleep
insomnia in two studies; a group-based intervention for crime apnea, narcolepsy, restless legs syndrome, or circadian disor-
victims with PTSD,16 and a single session behavioral protocol ders, and those with active drug or alcohol abuse or dependence
for adult victims of violent crime.17 Both produced improve- were excluded. All participants were required to have a PTSD
ments in nightmares, sleep quality and PTSD symptoms. Even diagnosis established using the Clinician-Administered PTSD
more recently, Nappi and colleagues published a study18 where- Scale (CAPS)21 or the SCID. Of the 93 self-referred prospective
in IRT was employed as part of a VA clinical service. Treat- study participants, 15 men and 7 women met study selection
ment effect sizes (Cohen’s d) for nightmares, insomnia severity, criteria, completed baseline procedures, and were subsequently
and PTSD symptoms in the 35 veterans completing the course randomized to treatment conditions (Figure 1). Of the 22 who
ranged from 0.16 (sleep quality) to 1.03 (PTSD symptoms). were ultimately randomized to condition, PTSD diagnosis was
Davis and colleagues developed a variation of IRT for established in 20 using the CAPs and in 2 using the SCID.
nightmares that incorporates some standard treatment aspects The average age of participants was 45.96 (SD 11.06). Most
of CBT-based PTSD treatment.19 Exposure, rescripting, and participants (73%) were either African American (N = 8) or
relaxation therapy (ERRT) was evaluated in a clinical trial of Caucasian (N = 8).The demographic and mental health charac-
trauma-exposed adults (81.6% female, 67.3% meeting criteria teristics of participants are outlined in Table 1. Enrolled study
for PTSD), and produced treatment effect sizes for nightmares, participants were allowed to be engaged in mental health treat-
PTSD symptoms, self-reported sleep problems, and restfulness ment during the study period. Table 2 outlines the specific type
at one-week post-intervention ranged from 0.10 to 0.97 (Co- and frequency of mental health contacts received by each study
hen’s d). Swanson and colleagues20 have since tested a com- participant during the study period.
bined version of ERRT and components of CBT for insomnia
in 10 veterans with PTSD in a 10-session group therapy format. Measures
Treatment effect sizes for sleep and nightmares in this study
ranged from 0.46 to 1.14 (Cohen’s d). Screening and Outcome Measures
Given that CBT for insomnia and IRT have both been effec- Duke Structured Interview for Sleep Disorders (DSISD):
tive in reducing the sleep complaints of veterans with PTSD, our The DSISD is an instrument developed to assist in ascer-
primary objective for the study was to assess the feasibility of taining DSM-IV and International Classification of Sleep

Journal of Clinical Sleep Medicine, Vol. 7, No. 1, 2011 58

 Sleep Intervention for Veterans with PTSD

Figure 1—Study participant flow chart Table 1—Baseline demographic and treatment characteristics
Difference
91 Phone Screened Usual Statistics
SIP Care F p
Age 47.00 50.22 0.42 0.53
54 Excluded (Mean Years39) (9.47) (11.62)
35 OSA symptoms reported Time since Trauma 12.51 20.22 1.00 0.33
7 Initial phone contact only (Mean Years 39) (14.47) (16.95)
4 Could not commit to required study appointments
χ2 p
3 Unstable living environment
3 No PTSD symptoms endorsed Gender (% Male) 66.7 55.6 0.23 0.63
1 Lived too far away Race 0.00 1.00
1 Not a Veteran % African American 33.3 33.3
% Caucasian 33.3 33.3
% Other 33.3 33.3
37 Office Screened Working? (% Yes) 33.3 67.7 2.00 0.16
Era of Service 3.72 0.29
% Vietnam Era 11.1 22.2
15 Excluded % Post-Vietnam Era 22.2 11.1
4 Withdrawal prior to baseline completion % Persian Gulf War 22.2 55.6
2 Did not meet diagnostic criteria for PTSD
% OEF/OIF 44.4 11.1
3 Insomnia Severity Index Score ≤ 14
6 Diagnosed with serious mental health condition Antidepressant use 55.6 55.6 0.00 1.00
(% at baseline)
Anxiolytic/hypnotic use 66.7 44.4 0.90 0.34
(% at baseline)
22 Randomized Mental health treatment during 33.3 55.6 0.90 0.34
study (%)
Medication management during 77.8 44.4 2.1 0.15
12 Assigned to 9 Assigned to Wait List study (%)
Intervention Condition Control Condition

9 Completed Follow-Up 9 Completed Follow-Up insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of
Assessment Assessment
moderate severity), and 22-28 (severe insomnia). The ISI has
adequate psychometric properties, has been validated against
diary and polysomnographic measures of sleep,25 and has been
Disorders sleep disorder diagnoses.22 The DSISD includes shown sensitive to therapeutic changes in several of our treat-
questions that incorporate criteria for ascertaining sleep dis- ment studies of insomnia. The ISI was used to determine treat-
orders within both the DSM-IV and the recently updated ment eligibility, to assess treatment outcome, and to determine
ICSD sleep disorder nosologies. The instrument has accept- clinical significance of study findings.
able reliability and discriminant validity, and is effective for Electronic Sleep Diary: Subjective sleep estimates were
discerning the types of sleep disorders that would disqualify obtained using a hand-held computer (PDA) containing an
participants for this study. interactive program that automates the collection of subjec-
Folstein Mini-Mental Status Exam: The Folstein Mini- tive sleep data. The PDA device was programmed to elicit
Mental Status Exam (MMSE)23 was administered to all study daily responses from participants and electronically record
candidates using standard administration/scoring procedures. multiple days of subjective sleep information, in addition to
The MMSE was used to identify and exclude individuals who the number and severity of nightmares for the previous night.
have cognitive deficits that would preclude their ability to pro- Five variables of interest were calculated or obtained from
vide informed consent or to fully participate in an interactive electronic sleep diaries, as follows: total sleep time (TST);
treatment process. As consistent with clinical applications for sleep onset latency (SOL); wake after sleep onset (WASO);
dementia screening, those with a score < 24 were excluded sleep efficiency % (SE); and nightmare frequency (NM fre-
from the study. quency).
Insomnia Severity Index (ISI): The ISI24 is a 7-item ques- The Pittsburgh Sleep Quality Index (PSQI): The PSQI26 is a
tionnaire that provides a global measure of perceived insom- self-rating scale that yields a quantitative index of general sleep
nia severity. Each item is rated on a 5-point Likert scale, and quality/disturbances. The PSQI is composed of 4 open-ended
the total score ranges from 0-28. The following guidelines are questions and 19 self-rated items (0-3 scale) assessing sleep
recommended for interpreting the total score: 0-7 (no clinical quality and disturbances over a 1-month interval, and yields a

59 Journal of Clinical Sleep Medicine, Vol. 7, No. 1, 2011

CS Ulmer, JD Edinger, PS Calhoun et al
a sensitivity of 86% and specificity of 78% for detecting major
Table 2—Frequency and type of mental health treatment depression, with a score ≥ 2 correctly categorizing the greatest
during the study period number of those with major depression.
Subject # Usual Care
10 5 sessions of Cognitive Processing Therapy for PTSD
Procedure
1 30-minute session of medication management/ Patients expressing interest in the study were first screened
supportive therapy for study eligibility by phone, with the exception of a few vet-
15 1 individual therapy session erans who presented to the office of the PI in response to flyers.
17 None
A more rigorous study screening assessment was conducted in
person. Those meeting study eligibility criteria were enrolled
39 2 Women's Trauma Group sessions
1 individual therapy session
in the study, completed a baseline demographics questionnaire,
and then conducted one week of sleep monitoring at home
48 None
using the electronic sleep diary. Upon returning with study
49 3 Women's Trauma Group sessions equipment, they completed a baseline packet of questionnaires
3 30-minute medication management/supportive therapy
assessing study outcome variables. They were then randomized
50 2 30-minute medication management/supportive therapy to condition and to therapist. Those in the intervention condition
2 Mental Health Wellness Group sessions
were scheduled for their first session of SIP within 3 weeks and
2 Smoking Cessation Group sessions
completed 6 bi-weekly intervention sessions over the following
83 None
12 weeks. Following their sixth session of SIP, they were again
87 2 individual therapy sessions sent home with equipment to monitor sleep and then completed
SIP the post-intervention questionnaire packet upon their return.
4 None The usual care control condition procedures were identical, ex-
9 4 individual therapy sessions cepting that they did not receive the intervention. All usual care
19 12 sessions of Anger Management Group Treatment participants were offered the opportunity to receive SIP at the
1 30-minute medication management/supportive therapy end of the study. All participants were paid $40 for each of the
24 1 30-minute medication management/supportive therapy 2 assessment periods and $15 for study screening.
25 1 30-minute medication management/supportive therapy
Therapists and Treatments
76 8 Individual Dialectical Behavior Therapy Group session Treatment was conducted by the PI (CSU) and the co-inves-
6 Seeking Safety Treatment sessions
2 30-minute medication management/supportive therapy tigator (JDE), who are both licensed clinical psychologists. Of
the 13 randomized to the intervention condition, CSU treated 5
82 2 30-minute medication management/supportive therapy
and JDE treated 8.
84 2 30-minute medication management/supportive therapy Usual Care/Usual Care Control: Veterans seeking assistance
88 1 30-minute medication management/supportive therapy for sleep disturbance and PTSD symptoms at the VA are often
SIP, Sleep Intervention for PTSD
treated for their symptoms by their primary care provider (PCP).
PCPs may provide hypnotics, antidepressants, anxiolytics, and
mood stabilizing medications to address veteran symptoms, in
global score of sleep quality, ranging from 0 to 21. A PSQI cut- addition to referring the veteran to the mental health clinic.
off score of 5 is a sensitive and specific value for predicting Sleep Intervention for PTSD (SIP): Patients in the SIP condi-
both clinical and laboratory assessments of sleep. The PSQI is a tion were eligible to receive the same elements as the Usual Care
widely used and valid instrument in clinical sleep research. The patients. In addition, these patients received 6 bi-weekly 1-h in-
Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI- dividual sessions with the interventionist, including 3 sessions
A)27 was used to assess PTSD-related sleep quality, and has of cognitive-behavioral therapy (CBT) for insomnia and 3 ses-
acceptable psychometric properties. A cut-off score of 4 was sions of imagery rehearsal therapy (IRT), in that order. CBT for
found to have excellent sensitivity and specificity for discrimi- insomnia consisted of a prescription for an individually tailored
nating those without PTSD from those with PTSD. behavioral regimen based upon sleep restriction theory, stimulus
PTSD Checklist-Military Version (PCL-M): The PCL-M28 control, standard sleep hygiene recommendations, and the iden-
is a 17-item self-report measure reflecting the degree to which tification and restructuring of dysfunctional beliefs and attitudes
veterans were bothered by each of 17 DSM-IV symptoms of regarding sleep. The IRT component included education about
PTSD in the past month. It is rated on a 5-point scale ranging the role of learning in nightmares, visual imagery skill building,
from 1 (“not at all”) to 5 (“extremely”). In Vietnam veterans, a and specific instructions on how to rescript nightmares. Partici-
PCL-M score ≥ 50 was found to be highly predictive of PTSD pants were instructed to change the nightmare in any way that
diagnosis using the SCID.29 The PCL-M was used to assess they liked and to practice this technique for ≥ 15 min/day, and to
treatment outcome and as an indicator of clinical significance practice rescripting no more than 2 new dreams per week.
of study findings.
Patient Health Questionnaire (PHQ-2): The PHQ-230 is a Analyses
2-item depression screening instrument that assesses frequency Baseline group differences were assessed using standard χ2
of depressed mood and anhedonia on a scale of 0 (not at all) to 3 procedures for categorical measures, and the F distribution for
(nearly every day). In a primary care population, the PHQ-2 has continuous variables.

Journal of Clinical Sleep Medicine, Vol. 7, No. 1, 2011 60

 Sleep Intervention for Veterans with PTSD
Intent–to–Treat Outcome Analyses
For all intent-to-treat outcomes, linear mixed-effects mod- Table 3—Baseline sleep characteristics
els (PROC MIXED in SAS) were used to determine expected Measure SIP Usual Care Difference Statistic
mean values at each time point and to test hypotheses of group
Mean SD Mean SD F p
differences. The model included time and the group-by-time
TST 315.45 70.13 311.99 70.71 0.01 0.91
interaction; an unstructured covariance matrix was used to ac-
WASO 85.07 62.11 103.83 28.31 0.71 0.41
count for the within-patient correlation over time. All available
data, including data from participants who subsequently dis- SOL 50.30 39.50 50.54 27.02 0.00 0.99
continued the study, were used for the longitudinal analyses. SE 70.52 14.89 66.47 8.47 0.54 0.47
Mixed-effects models assume non-informative dropout, mean- NM 0.72 0.43 0.59 0.68 0.32 0.56
Frequency
ing that the probability of dropout may depend on covariates or
a participants’ previous responses but not on current or future ISI 22.77 4.57 22.00 3.97 0.17 0.69
responses.31 A p value < 0.05 was considered statistically sig- PCL-M 63.08 12.47 63.44 11.66 0.01 0.95
nificant. Due to a PDA programming error, we lost a significant PHQ 3.77 1.74 3.89 2.09 0.02 0.89
portion of the data for nightmare severity, so this variable was PSQI 14.17 3.27 14.33 3.35 0.01 0.91
not included in analyses. PSQI-A 10.00 4.10 10.00 5.29 0.00 1.00

Completer Outcome Analyses

To analyze outcomes for completers only, a series of ANO- were no dropouts from the usual care group. The 4 participants
VAs (analysis of variances) involving one between-subjects who did not complete the study were all male OEF/OIF vet-
factor (SIP + Usual Care vs. Usual Care Only) and one within- erans. They were also younger (F1,20 = 7.47, p = 0.01, Drop
subjects factor (time) were used to assess for group by time inter- Out M = 34, SD = 2.94, Completer M = 48.61, SD = 10.42),
actions. Since one study participant in the intervention group did had greater sleep onset latency (F1,20 = 5.76, p = 0.03, Drop
not provide post-intervention sleep log data, these analyses were Out M = 83.93, SD = 52.66, Completer M = 42.95, SD = 25.15),
conducted on 9 usual care participants and 8 intervention partici- reported less restful sleep on diaries (F1,20 = 5.51, p = 0.03, Drop
pants. A p value < 0.05 was considered statistically significant. Out M = 2.5, SD = 0.37, Completer M = 4.08, SD = 1.31),
and had poorer sleep quality (higher PSQI scores) (F1,19 = 4.69,
Effect Size Calculations p = 0.04, poorer sleep quality) than study completers at base-
Effect sizes were calculated for each outcome by subtract- line. Two veterans dropped out due to work conflicts, one be-
ing post-intervention values for the usual care group from post- cause of the distance from his residence to the VA, and one was
intervention values for the treatment group, and then dividing lost to follow-up. Those not completing the study did not other-
by the pooled baseline standard deviation. wise differ from completers on demographic characteristics or
outcome measures.
Test of Clinical Significance
To assess the clinical significance of our findings, we em- Baseline Comparisons
ployed the criteria used by Morin and colleagues,32 with remis- Groups were compared on baseline demographic and out-
sion from insomnia defined as a post-intervention ISI score ≤ 7 come characteristics using univariate ANOVA analyses and χ2
(no insomnia), and response defined as an 8-point drop in ISI analyses, as appropriate, for those completing the study. Groups
score (a categorical change) from pre- to post-assessment. As did not differ on age, ethnicity, or gender distribution, time
discussed above, remission from PTSD was defined as a PCL- since trauma, or the number of Criterion A traumatic events
M score ≤ 49; sleep quality remission was defined as a post- (Table 1). In addition, participants did not differ across groups
intervention PSQI score ≤ 5; and remission from PTSD-specific on any baseline outcome variables (Table 3). Three variables
disruptive nocturnal behaviors was defined as a PSQI-A post- were considered as possible covariates: age, time since trauma,
intervention score < 4.There are no established criteria for sleep and baseline anxiolytic/hypnotic medication use. Since none
diary values reflecting “normal” sleep in those with PTSD. of these variables correlated with baseline outcome measures,
However, a criterion of < 31 min of WASO or SOL was found to they were not included as covariates in analyses.
discriminate those with insomnia from normal sleepers.22 Since
individuals with PTSD endorse high levels of insomnia, we Therapist Effects
utilized this criterion as being reflective of normal WASO and A series of repeated measures ANOVAs were conducted to
SOL at post-intervention. Treatment response status was evalu- assess for therapist effects for each outcome measure (Outcome
ated using χ2 analyses, wherein the frequency of responders and Measure × Group × Therapist). No therapist effects or group by
remitters, as defined above, were compared across conditions. therapist effects were found for any outcome measures.

Mental Health Treatment Group Effects

RESULTS Chi-square analyses were used to assess for group differenc-
es on treatment engagement during the study protocol. Groups
Treatment Completers versus Drop-Outs did not differ on the percentage engaged in mental health treat-
Four of the 22 randomized study participants dropped out ment (χ2 = 0.90, p = 0.34) or medication management (χ2 = 2.10,
of the intervention group prior to completing the study. There p = 0.15) during the study period (See Table 2).

61 Journal of Clinical Sleep Medicine, Vol. 7, No. 1, 2011

CS Ulmer, JD Edinger, PS Calhoun et al

Table 4—Comparison of predicted means, standard error (SE) values and treatment effect sizes for intent-to-treat groups on
sleep diary outcomes
Measure Baseline Post-Intervention Predicted Difference Statistic Effect Size
SIP Group TAU Group F Cohen’ s d
TST (Hours) M 5.23 6.47 5.26
6.33* 1.06
SE 0.24 0.37 0.35
WASO (Minutes) M 92.75 42.03 88.00
5.91* -0.90
SE 10.87 14.47 13.73
SOL (Minutes) M 50.40 22.39 45.03
10.17** -0.66
SE 7.30 6.55 6.32
SE (Percentage) M 68.86 86.89 70.91
14.61** 1.27
SE 2.68 3.24 3.07
NM Frequency M 0.67 0.51 0.83
5.03* -0.60
(Mean per Night) SE 0.11 0.18 0.17

*p < 0.05, **p < 0.01

Table 5—Comparison of means, standard error (SE) values and treatment effect sizes for participants with complete baseline
and post-intervention data on sleep log outcomes
Measure Baseline Post-Intervention ANOVA Statistics
SIP TAU GROUP (A) TIME (B) A×B A×B
Sleep Log Variable N=8 N=9 F F F Cohen’s d
TST (Hours) M 5.27 6.56 5.24
2.11 4.08 3.54 1.06
SE 0.29 0.46 0.35
WASO (Minutes) M 88.93 30.95 92.58
8.54* 4.31* 1.14 -1.37
SE 10.58 7.34 18.28
SOL (Minutes) M 42.95 12.45 45.11
6.52* 8.17* 2.68 -1.30
SE 5.93 2.11 8.92
SE (Percentage) M 69.98 89.58 69.92
8.51* 9.99** 3.70 1.48
SE 3.12 2.06 4.24
NM Frequency M 0.63 0.27 0.73
0.95 0.15 4.96* -0.89
(Mean per Night) SE 0.53 0.26 0.94

*p < 0.05, **p < 0.01

Sleep Diary Outcomes Questionnaire Outcomes

Intent-to-treat statistical analyses showed a significant group Intent-to-treat statistical analyses showed a significant group
by time interaction in favor of SIP over the usual care condi- by time interaction in favor of SIP over the usual care condition
tion for all sleep diary outcomes (Table 4). SIP produced sig- for most questionnaire outcomes. SIP produced significantly
nificantly greater baseline to post-intervention improvements greater improvements in insomnia severity (ISI) (F1,21 11.80,
in sleep diary measures of TST (F1,21 6.33, p = 0.02), WASO p = 0.003), PTSD symptoms (PCL-M) (F1,21 22.72, p = 0.0001),
(F1,21 5.91, p = 0.02), SOL (F1,21 10.17, p = 0.004), SE (F1,21 and sleep quality (PSQI) (F1,21 17.31, p = 0.0005) (Table 6).
14.61, p = 0.001), and nightmare frequency (F1,21 5.03, p = 5.03, Groups did not differ at post-intervention on depression (PHQ-
p = 0.04) (Table 4). The effect sizes for all sleep diary outcomes 2) or the PTSD-specific sleep quality measure (PSQI-A). The
fell in the “medium” to “large” range using Cohen’s original effect size for all significant questionnaire outcomes fell in the
conceptualization of these terms.33 “large” range, and in the “small to moderate” range for nonsig-
Completer analyses revealed a significant group by time in- nificant questionnaire outcomes.
teraction for nightmare frequency (F1,15 = 4.96, p = 0.04), with ANOVAs were then conducted to assess for group differ-
those in the intervention group reporting a significantly greater ences for those with complete baseline and post-intervention
reduction in nightmares from baseline to post-intervention than data on the amount of change in their scores on self-report
the usual care group (Table 5). Trends toward significance were questionnaires (ISI, PCL-M, PHQ, PSQI, and PSQI-A) from
found for total sleep time (F1,15 = 3.54, p = 0.08) and sleep ef- baseline to post-intervention (Table 7). ANOVAs revealed a
ficiency percentage (F1,15 = 3.70, p = 0.07), with the intervention significant time by group interaction for the ISI (F3,14 = 9.88,
group reporting more total sleep time and a higher sleep effi- p = 0.006), the PCL-M (F3,14 = 17.63, p = 0.001), and the PSQI
ciency at post-intervention relative to usual care. Effect sizes for (F3,14 = 15.91, p = 0.001), with those in the intervention condi-
all completers-only sleep log outcomes fell in the “large” range. tion faring better at post-intervention than the usual care condi-

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 Sleep Intervention for Veterans with PTSD

Table 6—Comparison of predicted means, standard error (SE) values, and treatment effect sizes for intent-to-treat groups on
questionnaire outcomes
Measure Baseline Post-Intervention Predicted Difference Statistic Effect Size
SIP Group TAU Group F Cohen’s d
ISI M 22.46 12.45 21.58
11.80** -2.15
SE 0.91 1.90 1.90
PCL-M M 63.23 45.25 66.08
22.72** -1.76
SE 2.53 3.51 3.51
PHQ M 3.81 3.45 4.06
0.86 -0.34
SE 0.39 0.54 0.54
PSQI M 14.24 9.31 14.47
17.31** -1.60
SE 0.70 1.07 1.07
PSQI-A M 10.00 7.74 9.11
0.76 -0.30
SE 0.96 1.36 1.36

*p < 0.05, **p < 0.01

Table 7—Comparison of means, standard error (SE) values and treatment effect sizes for participants with complete baseline
and post-intervention data on outcome questionnaires
Measure Baseline Post-Intervention ANOVA Statistics
SIP TAU GROUP (A) TIME (B) A×B A×B
Questionnaires N=9 N=9 F F F Cohen’s d
ISI M 22.22 12.44 21.44
5.23* 12.34** 9.88** -2.17
SE 0.98 2.43 1.25
PCL-M M 62.39 44.00 66.22
5.29* 9.24** 17.63** -1.85
SE 2.83 4.99 2.99
PHQ M 3.61 3.11 4.11
0.93 0.00 0.38 -0.55
SE 0.43 0.72 0.54
PSQI M 13.67 8.22 14.56
6.47* 13.21** 15.91** -2.05
SE 0.73 1.41 1.09
PSQI-A M 9.28 6.56 9.11
0.93 3.18 0.47 -0.58
SE 1.04 1.54 1.76

*p < 0.05, **p < 0.01

tion. Groups did not differ significantly in depression (PHQ) the intervention group participants (4/4 or 100%) in this sub-
or trauma-related sleep quality (PSQI-A) change from baseline sample had achieved “normal” SOL as compared to only 14%
to post-intervention. Effect sizes for all significant completers- of usual care participants (1/7) (χ2 = 7.5, p = 0.02). Groups did
only questionnaire outcomes fell in the “very large” (> 1.50) not differ at post-intervention on the percentage of WASO re-
range, and in the “moderate” range for nonsignificant question- mitters (χ2 = 0.79, p = 0.55), with 1 of 9 remitting in the wait list
naire outcomes. group and 2 of 7 in the intervention group.

Clinical Significance Findings Questionnaire Outcomes

Figures 4, 5, and 6 depict baseline to post-intervention
Sleep Diary Outcomes change in ISI, PCL-M, and PSQI scores, respectively. At
Post-assessment sleep diary data was not available for 1 post-intervention, one participant in the intervention group
participant in the intervention group. Figures 2 and 3 depict remitted from insomnia, (1/9 or 11%), and 4 were insomnia
baseline to post-assessment change in SOL and WASO in those responders (4/9 or 44.4%). As depicted in Figure 5, 1 partici-
providing complete sleep diary data. As depicted, 4 subjects in pant in each group had a baseline PCL-M score < 50. Baseline
the intervention group had baseline SOL values < 31 min, and PCL-M values did not differ between groups when consider-
one subject had a baseline WASO value < 31 min. In the wait- ing only those participants with complete sleep diary data and
list group, 2 participants had SOL values < 31 min. Baseline baseline PCL-M values above the PTSD screening cutoff of
SOL and WASO values did not differ between groups when 50 (F = 0.17, p = 0.69). At post-intervention, however, half
considering only those participants with complete sleep diary of the intervention group participants in this subsample (4/8
data and baseline SOL and WASO values above the criterion or 50%) had remitted from PTSD as compared to none of the
level for “normal” sleep. At post-intervention, however, all of usual care participants (0/8) (χ2 = 5.33, p = 0.04). In terms of

63 Journal of Clinical Sleep Medicine, Vol. 7, No. 1, 2011

CS Ulmer, JD Edinger, PS Calhoun et al

Figure 2—Sleep onset latency

Wait List Control Sleep Intervention for PTSD
120 SOL BL
SOL POST
100

80
Score

60

40

20

0
10 15 17 39 48 49 50 83 87 4 9 19 24 25 76 82 84

Participant #

Figure 3—Wake after sleep onset

Wait List Control Sleep Intervention for PTSD
250
WASO BL
WASO POST
200

150
Score

100

50

0
10 15 17 39 48 49 50 83 87 4 9 19 24 25 76 82 84

Participant #

Figure 4—Insomnia severity

ISI BL Wait List Control Sleep Intervention for PTSD

35 ISI POST

30

25

20
Score

15

10

0
10 15 17 39 48 49 50 83 87 4 9 19 24 25 76 82 84 88

Participant #

Journal of Clinical Sleep Medicine, Vol. 7, No. 1, 2011 64

 Sleep Intervention for Veterans with PTSD

Figure 5—PTSD symptoms

PCL-M BL
PCL-M POST
Wait List Control Sleep Intervention for PTSD
90

80

70

60

50
Score

40

30

20

10

0
10 15 17 39 48 49 50 83 87 4 9 19 24 25 76 82 84 88

Participant #

Figure 6—Sleep quality

Wait List Control Sleep Intervention for PTSD
25 PSQI BL
PSQI POST

20

15
Score

10

0
10 15 17 39 48 49 50 83 87 4 9 19 24 25 76 82 84 88

Participant #

sleep quality, groups did not differ at post-intervention on the tion to usual care in terms of differential symptoms of sleep
percentage of sleep quality remitters, with 3 (3/9 or 33.3%) of disturbance at post-intervention. We hypothesized that this
those in the intervention group remitting, and none of those combined intervention, in addition to usual care, would pro-
in the usual care group (0/9 or 0%). Finally, with regard to duce better outcomes than usual care alone. Our hypothesis
PTSD-specific disruptive nocturnal behaviors, groups did not was supported in terms of both average improvement across
differ at post-intervention with 3 (3/9 or 33.3%) of those in individual measures and the clinical significance of our find-
the intervention group remitting and one (1/9 or 11.1%) in the ings. Intent-to-treat analyses revealed medium to large effect
usual care group (χ2 = 1.29, p = 0.26). sizes (group differences) for all sleep diary outcomes, and very
large treatment effects (Cohen’s d > 1.50) for insomnia sever-
DISCUSSION ity, sleep quality, and PTSD symptoms. In contrast, none of the
participants in the usual care group responded or remitted from
The primary purpose of our study was to assess the feasibil- insomnia or PTSD, and did not improve from baseline on sleep
ity of SIP using a randomized trial design. Although the study quality. SIP did not produce a treatment effect for depression,
revealed the need for slight procedural changes to be incorpo- and although SIP is not designed to treat depression, this find-
rated into a larger trial, the overall findings suggest that the in- ing was surprising in light of the treatment effect on correlated
tervention is feasible and generally acceptable to veterans with issues: insomnia and PTSD. We suspect that the failure to find a
PTSD. Our secondary purpose was to compare the interven- significant effect for depression may be related to the restricted

65 Journal of Clinical Sleep Medicine, Vol. 7, No. 1, 2011

CS Ulmer, JD Edinger, PS Calhoun et al
total score range (0-6) for the depression measure employed in As consistent with expectations for an intervention targeting
this study (PHQ-2). sleep disturbance, SIP had the greatest impact on self-reported
In spite of large effect sizes, remission rates were lower than insomnia severity. SIP’s potent effect on PTSD symptoms, how-
hoped for measures of both insomnia (11%) and sleep quality ever, was a less expected and arguably, one of the more interest-
(33%). In fact, it is particularly surprising that remission rates ing findings of our study. The second largest treatment effect
for sleep targets were lower than for PTSD (50%). Comparison for SIP was found in the domain of PTSD symptoms (Cohen’s
of PSQI and ISI items across groups does not reveal a consis- d = 1.76), and half of those in the intervention group scored
tent indicator of residual symptomatology that might explain in the subclinical PTSD screening range at post-intervention.
the low remission rates for insomnia and sleep quality. Howev- This finding is consistent with the suggestion of some research-
er, of all sleep log variables assessed, the treatment effect sizes ers, that sleep plays a significant role in the development and/or
were lowest for nightmare frequency. Since there was no fol- maintenance of PTSD.34-38
low-up assessment included in the design of this pilot study, it Krakow and colleagues have observed that many individu-
remains unknown if the IRT skills acquired during the interven- als with post-trauma symptoms, would prefer to address their
tion might have resulted in better outcomes at a later follow-up insomnia first, then nightmares, and then PTSD, as applicable,39
assessment, or if decrements in clinical improvements would be and their observation is consistent with our clinical experience
revealed over time. However, it is plausible that residual night- of PTSD patients seeking treatment for sleep disturbance. Ac-
mares in the treatment group might explain the low remission ceptability of treatment is a highly relevant topic for a mental
rates for insomnia and sleep quality. This explanation is also health condition for which avoidance is a primary cognitive
consistent with our finding of greater remission rates for SOL feature. We did not assess the relative acceptability of sleep
than WASO on sleep logs. treatment versus PTSD treatment. However, if our clinical ex-
Randomized controlled trials of sleep-focused interventions perience on this topic is based in fact, that those who are strug-
in veterans with PTSD are largely absent from the empirical gling with PTSD are more likely to seek and complete treatment
literature. However, our findings are generally consistent with for sleep disturbance, then it may be prudent to promote sleep
the available studies addressing post-trauma sleep disturbance, disturbance interventions as a first-line PTSD treatment. Our
excepting the larger effect size produced by SIP relative to other evidence, along with the reports of other researchers, suggests
interventions. SIP produced significant treatment effects in the that about half of participants could remit from PTSD following
same domains as those found in the clinical outcomes of IRT treatment for sleep disturbance.
for veterans described by Nappi and colleagues,18 including As noted above, in spite of differences in approach, these in-
nightmares, insomnia severity, and PTSD symptoms, with the terventions all facilitate a reduction in both nightmare frequen-
exception that we also found a significant treatment effect for cy and PTSD symptoms. One explanation for this consistent
sleep quality. Our findings are also generally consistent with finding across approaches is that ERRT, IRT, and SIP all pro-
those of Davis et al.19 ERRT resulted in a significant improve- mote an observer stance towards dream content. Several par-
ment in depression, however, whereas depression did not im- ticipants in our study reported a significant shift in nightmare
prove significantly with SIP, as discussed above. Insomnia was frequency with the realization that they could alter the course of
not assessed, and sleep diaries were not included in the study by the dream while it was occurring. These participants described
Davis et al., so no comparisons can be made here. a shift from being part of the dream to being an observer of the
SIP differs from previously assessed interventions in at least dream. These reports are consistent with a shift towards meta-
two areas. First, exposure is not an intended mechanism of cognitive insight, as described by Teasdale,40 wherein “A dis-
change in SIP, in contrast with empirically based PTSD treat- tinction is made between metacognitive knowledge (knowing
ments and ERRT. In spite of differences in treatment protocols, that thoughts are not necessarily always accurate) and metacog-
however, SIP (50%) and ERRT (46%) produced similar rates nitive insight (experiencing thoughts as events in the field of
of PTSD remission. Our finding of a large treatment effect for awareness, rather than as direct readouts on reality)(pg. 146).”
PTSD symptoms challenges the notion that exposure is a nec- Recent findings of a study examining brain activity during self-
essary component of PTSD and nightmare treatment, since SIP related awareness tasks found that, by simply placing one’s at-
produced significant reductions in PTSD symptoms and night- tention on feelings and emotions one could modulate amygdala
mare frequency but involves very limited exposure to night- activation, thereby initiating the emotion regulation process.41
mare content. These authors propose that making oneself aware of emotions
Second, SIP incorporates an intervention that specifically may provide a therapeutic distance that facilitates emotion reg-
targets insomnia and is heavily focused on regulation of erratic ulation. Similarly, rather than promoting avoidance, IRT and
sleep schedules. Given the importance of homeostatic and cir- similar approaches promote a stance of “observer” versus “ex-
cadian mechanisms on sleep and their role in sleep quality, it is periencer” of affectively charged dream content.
our belief that behavioral sleep targets should be addressed first
to provide the foundation for addressing other aspects of sleep Limitations
disturbance (e.g., nightmares). Addressing nightmares with- The findings of our study should be viewed in light of the
out first targeting behaviors that serve to maintain insomnia is limitations inherent to a pilot study. Namely, our sample size
likely to impair the effectiveness of the nightmare intervention was very small, so we cannot be certain that the large effect
since sleep-disruptive behaviors may persist. However, in the sizes seen in this trial would be seen in a larger trial of SIP.
absence of research showing a sequence effect, this assertion Also, this study did not include an active control condition, and
remains an empirical question. no follow-up data was collected. Thus, we cannot determine

Journal of Clinical Sleep Medicine, Vol. 7, No. 1, 2011 66

 Sleep Intervention for Veterans with PTSD
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Journal of Clinical Sleep Medicine, Vol. 7, No. 1, 2011 68