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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00108628
First received: April 15, 2005
Last updated: February 17, 2015
Last verified: February 2015
Results First Received: December 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Post-traumatic Stress Disorder
Interventions: Behavioral: Imagery Rehearsal
Behavioral: Sleep and Nightmare Management

  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
Ten participants dropped out prior to randomization.

Reporting Groups
  Description
Imagery Rehearsal Therapy

Imagery Rehearsal Therapy

Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.

Sleep and Nightmare Management

Sleep and Nightmare Management

Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets


Participant Flow:   Overall Study
    Imagery Rehearsal Therapy     Sleep and Nightmare Management  
STARTED     61     63  
Received One or More Sessions     53     58  
Completed Treatment     42     57  
COMPLETED     41     53  
NOT COMPLETED     20     10  
Withdrawal by Subject                 17                 9  
Lack of Efficacy                 2                 1  
Death                 1                 0  



  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
Imagery Rehearsal Therapy

Imagery Rehearsal Therapy

Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.

Sleep and Nightmare Management

Sleep and Nightmare Management

Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets

Total Total of all reporting groups

Baseline Measures
    Imagery Rehearsal Therapy     Sleep and Nightmare Management     Total  
Number of Participants  
[units: participants]
  61     63     124  
Age  
[units: years]
Mean (Standard Deviation)
  59.79  (3.18)     59.06  (3.86)     59.42  (3.55)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     61     63     124  
Region of Enrollment  
[units: participants]
     
United States     61     63     124  



  Outcome Measures
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1.  Primary:   Weekly Number of Nightmares   [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ]

2.  Primary:   Weekly Nights With a Nightmare   [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ]

3.  Primary:   Pittsburgh Sleep Quality Index   [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ]

4.  Secondary:   Pittsburgh Sleep Quality Index - Addendum   [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ]

5.  Secondary:   Nightmare Effects Survey   [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ]

6.  Secondary:   PTSD Military Checklist   [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ]

7.  Secondary:   Beck Depression Inventory   [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ]

8.  Secondary:   SF-36 Physical Component   [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ]

9.  Secondary:   SF-36 Mental Component   [ Time Frame: Baseline and 1, 3, and 6 months post-treatment ]

10.  Secondary:   Clinician-Administered PTSD Scale (CAPS)   [ Time Frame: Baseline and 1 month 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Richard Ross
Organization: Philadelphia VA Medical Center
phone: (215) 823-4046
e-mail: Richard.Ross2@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00108628     History of Changes
Other Study ID Numbers: CLIN-018-03S
Study First Received: April 15, 2005
Results First Received: December 3, 2014
Last Updated: February 17, 2015
Health Authority: United States: Federal Government