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A Cognitive-Behaviour Therapy (CBT) Self-Management Approach for Insomnia in Chronic Pain: A Randomized Control Trial

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ClinicalTrials.gov Identifier: NCT01188460
Recruitment Status : Completed
First Posted : August 25, 2010
Results First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Collaborator:
The Ottawa Hospital
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions: Insomnia
Chronic Pain
Interventions: Behavioral: Self-help manual for insomnia
Behavioral: Sleep diary

  Participant Flow

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
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Reporting Groups
  Description
Control Group

Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints

Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality

Experimental Group

Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints

Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality


Participant Flow:   Overall Study
    Control Group   Experimental Group
STARTED   25   23 
COMPLETED   25   23 
NOT COMPLETED   0   0 



  Baseline Characteristics

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
Control Group

Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only, complete questionnaires at three study timepoints

Sleep diary: Completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality

Experimental Group

Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries, implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints

Self-help manual for insomnia: Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality

Total Total of all reporting groups

Baseline Measures
   Control Group   Experimental Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   23   48 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   24   23   47 
   44.29  (9.55)   47.96  (10.21)   46.09  (9.94) 
[1] Missing data for age for one participant
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   25   23   48 
Female      14  56.0%      15  65.2%      29  60.4% 
Male      11  44.0%      8  34.8%      19  39.6% 


  Outcome Measures

1.  Primary:   Insomnia Severity Index (ISI)   [ Time Frame: Timepoint 2 (week 7 of study participation) ]

2.  Primary:   Sleep Diary- Total Sleep Time   [ Time Frame: Timepoint 2 (week 7 of study participation). ]

3.  Primary:   Sleep Diary- Time to Fall Asleep   [ Time Frame: Timepoint 2 (week 7 of study participation). ]

4.  Primary:   Sleep Diary- Number of Nocturnal Awakenings   [ Time Frame: Timepoint 2 (week 7 of study participation). ]

5.  Primary:   Sleep Diary- Sleep Efficiency   [ Time Frame: Timepoint 2 (week 7 of study participation). ]

6.  Primary:   Sleep Diary- Sleep Quality   [ Time Frame: Timepoint 2 (week 7 of study participation). ]

7.  Secondary:   Pain Severity Rating   [ Time Frame: Timepoint 2 (week 7 of study participation). ]

8.  Secondary:   Pain Disability Index (PDI)   [ Time Frame: Timepoint 2 (week 7 of study participation). ]

9.  Secondary:   Hospital Anxiety and Depression Scale (HADS)   [ Time Frame: Timepoint 2 (week 7 of study participation). ]

10.  Secondary:   Pre-Sleep Arousal Scale (PSAS)   [ Time Frame: Timepoint 2 (week 7 of study participation). ]

11.  Secondary:   Fatigue Severity Scale (FSS)   [ Time Frame: Timepoint 2 (week 7 of study participation). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Keith Wilson
Organization: OHRI
e-mail: kewilson@toh.ca



Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01188460     History of Changes
Other Study ID Numbers: 2009902
First Submitted: August 19, 2010
First Posted: August 25, 2010
Results First Submitted: January 20, 2017
Results First Posted: February 19, 2018
Last Update Posted: February 19, 2018