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N/A N=124 Randomized Single-blind Treatment

Cognitive Behavioral Treatments for Post-traumatic Stress Disorder (PTSD) Sleep Disturbance

Post-traumatic Stress Disorder

Enrolled (actual)
124
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Weekly Number of Nightmares — 3.95; 3.88; 3.28; 3.47 weekly nightmares

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Imagery Rehearsal (Behavioral); Sleep and Nightmare Management (Behavioral)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
US Department of Veterans Affairs
Primary completion
Sep 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Weekly Number of Nightmares
3.95; 3.88; 3.28; 3.47; 3.61; 3.09
PRIMARY
Weekly Nights With a Nightmare
2.96; 3.00; 2.67; 2.78; 3.10; 2.55
PRIMARY
Pittsburgh Sleep Quality Index
13.40; 12.85; 12.09; 11.82; 12.57; 11.70
SECONDARY
Pittsburgh Sleep Quality Index - Addendum
17.51; 17.01; 16.71; 16.29; 16.58; 16.36
SECONDARY
Nightmare Effects Survey
26.39; 24.11; 24.12; 24.66; 25.28; 24.02
SECONDARY
PTSD Military Checklist
62.73; 65.06; 58.83; 60.96; 60.13; 61.13
SECONDARY
Beck Depression Inventory
26.85; 23.51; 24.16; 22.31; 24.80; 23.76
SECONDARY
SF-36 Physical Component
37.17; 38.53; 39.48; 36.84; 37.72; 35.96
SECONDARY
SF-36 Mental Component
29.69; 34.52; 32.33; 32.84; 30.98; 34.00
SECONDARY
Clinician-Administered PTSD Scale (CAPS)
81.34; 79.48; 74.04; 74.85

Summary

The purpose of this study is to compare the effectiveness of two cognitive behavioral group psychotherapy interventions in controlling the subjective sleep disturbance in veterans with Post-traumatic Stress Disorder.

Eligibility Criteria

Inclusion Criteria

  • Male
  • Vietnam Combat Veteran
  • Diagnosis of combat-related PTSD
  • Stable psychotropic regimen for a minimum of three months
  • Experiences recurrent nightmares

Exclusion Criteria

  • Bipolar disorder, delirium, dementia, amnestic and other cognitive disorders
  • Schizophrenia and other psychotic disorders
  • Substance abuse or dependence within the last six months
  • Untreated medical disorders known to impact sleep
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00108628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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