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Efficacy of Sleep Interventions for Posttraumatic Stress Disorder (PTSD) (EASI-P)

This study has been completed.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Anne Germain, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00393874
First received: October 26, 2006
Last updated: September 6, 2016
Last verified: September 2016
Results First Received: January 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Anxiety Disorders
Mood Disorders
Insomnia
Nightmares
Interventions: Behavioral: Behavioral Sleep Intervention
Drug: Prazosin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Medication

Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications 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.

Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). 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.

Behavioral

Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute "booster" session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).

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.

Placebo

Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. 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. We will monitor subjects carefully and on a weekly basis.

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.


Participant Flow:   Overall Study
    Medication   Behavioral   Placebo
STARTED   18   17   15 
COMPLETED   15   13   13 
NOT COMPLETED   3   4   2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Medication

Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications 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.

Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). 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.

Behavioral

Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute "booster" session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).

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.

Placebo

Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. 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. We will monitor subjects carefully and on a weekly basis.

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.

Total Total of all reporting groups

Baseline Measures
   Medication   Behavioral   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   17   15   50 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.4  (11.9)   40.0  (14.1)   43.6  (14.0)   41.0  (13.3) 
Gender 
[Units: Participants]
       
Female   2   3   0   5 
Male   16   14   15   45 
Region of Enrollment 
[Units: Participants]
       
United States   18   17   15   50 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Insomnia Severity Index   [ Time Frame: Screening, Post, and Follow-up ]

2.  Primary:   Sleep Diary Measures   [ Time Frame: baseline and post ]

3.  Primary:   PSG Composite Measure   [ Time Frame: Baseline sleep study and post sleep study ]

4.  Primary:   PSQI   [ Time Frame: Baseline, post, 4 months post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Anne Germain
Organization: University of Pittsburgh
phone: 412-383-2150
e-mail: GERMAX@upmc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Anne Germain, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00393874     History of Changes
Other Study ID Numbers: PR054093
W81XWH-06-1-0257
Study First Received: October 26, 2006
Results First Received: January 7, 2016
Last Updated: September 6, 2016