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Treatment of Insomnia Secondary to Chronic Pain

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Wilfred Pigeon, University of Rochester
ClinicalTrials.gov Identifier:
NCT00127790
First received: August 3, 2005
Last updated: September 14, 2012
Last verified: September 2012
Results First Received: June 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Insomnia
Pain
Interventions: Behavioral: CBT for Insomnia (CBT-I)
Behavioral: CBT for Pain (CBT-P)

  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
Men and women aged 35-75 experiencing chronic pain and insomnia were recruited from the community through newspaper advertisements and from local pain clinics via recruitment flyers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants completed intake interview, physical exam, clinical chemistries and toxicology screens; completed daily pain-sleep diaries for two weeks; and then underwent polysomnography. Seven subjects were excluded prior to randomization (4 due to sleep apnea, 1 did not meet pain severity criteria, and 2 subsequently declined to participate).

Reporting Groups
  Description
Cognitive-Behavioral Therapy for Insomnia (CBT-I) Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
Cognitive-Behavioral Therapy for Pain (CBT-P) Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P) Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
Wait-List Control (WL) Waitlist Control condition (WL) with no contact during the intervention period.

Participant Flow for 2 periods

Period 1:   Pre-Treatment
    Cognitive-Behavioral Therapy for Insomnia (CBT-I)     Cognitive-Behavioral Therapy for Pain (CBT-P)     Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)     Wait-List Control (WL)  
STARTED     6 [1]   5     6     4  
COMPLETED     6     5     6     4  
NOT COMPLETED     0     0     0     0  
[1] 7 enrolled subjects were withdrawn prior to randomization; 21 of 28 enrolled were randomized.

Period 2:   Post-Treatment
    Cognitive-Behavioral Therapy for Insomnia (CBT-I)     Cognitive-Behavioral Therapy for Pain (CBT-P)     Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)     Wait-List Control (WL)  
STARTED     6     5     6     4  
COMPLETED     6     5     6     4  
NOT COMPLETED     0     0     0     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
Cognitive-Behavioral Therapy for Insomnia (CBT-I) Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
Cognitive-Behavioral Therapy for Pain (CBT-P) Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P) Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
Wait-List Control (WL) Waitlist Control condition (WL) with no contact during the intervention period.
Total Total of all reporting groups

Baseline Measures
    Cognitive-Behavioral Therapy for Insomnia (CBT-I)     Cognitive-Behavioral Therapy for Pain (CBT-P)     Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)     Wait-List Control (WL)     Total  
Number of Participants  
[units: participants]
  6     5     6     4     21  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     6     4     6     4     20  
>=65 years     0     1     0     0     1  
Age  
[units: years]
Mean ± Standard Deviation
  45.7  ± 8.2     55.8  ± 9.8     50.5  ± 8.5     52.3  ± 1.0     50.7  ± 8.3  
Gender  
[units: participants]
         
Female     4     2     6     2     14  
Male     2     3     0     2     7  
Region of Enrollment  
[units: participants]
         
United States     6     5     6     4     21  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Insomnia Severity   [ Time Frame: Pre to Post Treatment Change (Over an average of approximately 10 weeks) ]

2.  Primary:   Pain Severity   [ Time Frame: Pre to Post Treatment Change (Over an average of approximately 10 weeks) ]

3.  Primary:   IL-6   [ Time Frame: Pre to Post Treatment Change (Over an average of approximately 10 weeks) ]

4.  Secondary:   Depression Severity   [ Time Frame: Pre to Post Treatment Chnage (Over an average of approximately 10 weeks) ]


  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
The foremost limitation of this pilot study is its small sample size, particularly for a four-arm design. Accordingly, a cautious approach to the interpretation of the findings is warranted.


  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: Wilfred Pigeon, PhD
Organization: Universityy of Rochester
phone: (585) 275-3374
e-mail: wilfred_pigeon@urmc.rochester.edu


No publications provided


Responsible Party: Wilfred Pigeon, University of Rochester
ClinicalTrials.gov Identifier: NCT00127790     History of Changes
Other Study ID Numbers: 160743209, F32NS049789, K23NR010408, R21AG023956; R24AG031089
Study First Received: August 3, 2005
Results First Received: June 12, 2012
Last Updated: September 14, 2012
Health Authority: United States: Institutional Review Board