Efficacy of Sleep Interventions for Posttraumatic Stress Disorder (PTSD)

NACompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

June 30, 2010

Study Completion Date

June 30, 2011

Conditions
Anxiety DisordersMood DisordersInsomniaNightmares
Interventions
BEHAVIORAL

Behavioral Sleep Intervention

Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction. Session 1 focuses on education on PDSD-related insomnia, nightmares, and sleep avoidance behaviors. The rationale for imagery rehearsal will then be presented, and the technique will be practiced once. Strategies for managing intrusive thoughts and images during the practice of imagery rehearsal will be discussed. Participants will be instructed to practice this technique at least three times each day for the duration of the treatment phase. During the second 45-minute session (Week 3), sleep schedules extracted from the pre-intervention sleep diary will be used to identify goals to reduce insomnia, i.e., for sleep restricted schedules, and activities to be performed out of bed when awake.

DRUG

Prazosin

Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). The target dose of prazosin is 10 mg. Some individuals may require doses up to 15 mg, (Murray Raskind, M.D., personal communication, February 4, 2005). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary. Medication will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.

DRUG

Placebo

Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed.

Trial Locations (1)

15213

Western Phychiatric Institute and Clinic, University of Pittsburgh Medical Center, Pittsburgh

All Listed Sponsors
collaborator

U.S. Army Medical Research and Development Command

FED

lead

University of Pittsburgh

OTHER

NCT00393874 - Efficacy of Sleep Interventions for Posttraumatic Stress Disorder (PTSD) | Biotech Hunter | Biotech Hunter