Trial Outcomes & Findings for A Cognitive-Behaviour Therapy (CBT) Self-Management Approach for Insomnia in Chronic Pain: A Randomized Control Trial (NCT NCT01188460)
NCT ID: NCT01188460
Last Updated: 2018-02-19
Results Overview
Measures insomnia symptoms, scores range from 0-28 with higher scores (ranging from 15-28) indicating clinical insomnia and therefore worse outcomes
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Timepoint 2 (week 7 of study participation)
Results posted on
2018-02-19
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
23
|
|
Overall Study
COMPLETED
|
25
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing data for age for one participant
Baseline characteristics by cohort
| Measure |
Control Group
n=25 Participants
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
n=23 Participants
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
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.29 years
STANDARD_DEVIATION 9.55 • n=24 Participants • Missing data for age for one participant
|
47.96 years
STANDARD_DEVIATION 10.21 • n=23 Participants • Missing data for age for one participant
|
46.09 years
STANDARD_DEVIATION 9.94 • n=47 Participants • Missing data for age for one participant
|
|
Sex: Female, Male
Female
|
14 Participants
n=25 Participants
|
15 Participants
n=23 Participants
|
29 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=25 Participants
|
8 Participants
n=23 Participants
|
19 Participants
n=48 Participants
|
PRIMARY outcome
Timeframe: Timepoint 2 (week 7 of study participation)Measures insomnia symptoms, scores range from 0-28 with higher scores (ranging from 15-28) indicating clinical insomnia and therefore worse outcomes
Outcome measures
| Measure |
Control Group
n=25 Participants
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
n=23 Participants
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
|
|---|---|---|
|
Insomnia Severity Index (ISI)
|
19.84 units on a scale
Standard Deviation 4.14
|
16.04 units on a scale
Standard Deviation 5.16
|
PRIMARY outcome
Timeframe: Timepoint 2 (week 7 of study participation).Measures: Total Sleep Time in hours, higher scores indicate better outcomes
Outcome measures
| Measure |
Control Group
n=25 Participants
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
n=23 Participants
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
|
|---|---|---|
|
Sleep Diary- Total Sleep Time
|
5.34 hours
Standard Deviation 1.12
|
5.46 hours
Standard Deviation 1.02
|
PRIMARY outcome
Timeframe: Timepoint 2 (week 7 of study participation).Measures: Time to Fall Asleep in minutes, higher scores indicate worse outcomes
Outcome measures
| Measure |
Control Group
n=25 Participants
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
n=23 Participants
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
|
|---|---|---|
|
Sleep Diary- Time to Fall Asleep
|
0.46 minutes
Standard Deviation 0.23
|
0.35 minutes
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: Timepoint 2 (week 7 of study participation).Measures: Number of Nocturnal Awakenings, higher scores indicate worse outcomes
Outcome measures
| Measure |
Control Group
n=25 Participants
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
n=23 Participants
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
|
|---|---|---|
|
Sleep Diary- Number of Nocturnal Awakenings
|
3 Number of nocturnal awakenings
Standard Deviation 1
|
3 Number of nocturnal awakenings
Standard Deviation 1
|
PRIMARY outcome
Timeframe: Timepoint 2 (week 7 of study participation).Measures: Sleep Efficiency (percentage)- higher scores indicate better outcomes
Outcome measures
| Measure |
Control Group
n=25 Participants
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
n=23 Participants
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
|
|---|---|---|
|
Sleep Diary- Sleep Efficiency
|
63.06 Percentage of efficiency
Standard Deviation 8.33
|
67.09 Percentage of efficiency
Standard Deviation 8.37
|
PRIMARY outcome
Timeframe: Timepoint 2 (week 7 of study participation).Measures: Sleep Quality (units on a scale from 0-10), higher scores indicate better outcomes
Outcome measures
| Measure |
Control Group
n=25 Participants
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
n=23 Participants
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
|
|---|---|---|
|
Sleep Diary- Sleep Quality
|
4 units on a scale
Standard Deviation 1
|
4 units on a scale
Standard Deviation 1
|
SECONDARY outcome
Timeframe: Timepoint 2 (week 7 of study participation).Measures pain severity, rated on scale from 0-10, total scores range from 0-40, higher scores indicate worse outcomes
Outcome measures
| Measure |
Control Group
n=25 Participants
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
n=23 Participants
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
|
|---|---|---|
|
Pain Severity Rating
|
27.96 units on a scale
Standard Deviation 5.19
|
25.35 units on a scale
Standard Deviation 6.93
|
SECONDARY outcome
Timeframe: Timepoint 2 (week 7 of study participation).Measures pain disability impact on various life domains, scores range from 0-70, higher scores indicate worse outcomes
Outcome measures
| Measure |
Control Group
n=25 Participants
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
n=23 Participants
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
|
|---|---|---|
|
Pain Disability Index (PDI)
|
48.12 units on a scale
Standard Deviation 11.46
|
46.13 units on a scale
Standard Deviation 10.76
|
SECONDARY outcome
Timeframe: Timepoint 2 (week 7 of study participation).Measures symptoms of depression and anxiety, total scores range from 0-42, higher scores indicate worse outcomes
Outcome measures
| Measure |
Control Group
n=25 Participants
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
n=23 Participants
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
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
|
22.08 units on a scale
Standard Deviation 7.43
|
19.43 units on a scale
Standard Deviation 5.32
|
SECONDARY outcome
Timeframe: Timepoint 2 (week 7 of study participation).Measures pre-sleep hyperarousal, total scores range from 16-80, higher scores indicate worse outcomes
Outcome measures
| Measure |
Control Group
n=25 Participants
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
n=23 Participants
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
|
|---|---|---|
|
Pre-Sleep Arousal Scale (PSAS)
|
44.84 units on a scale
Standard Deviation 11.52
|
35.43 units on a scale
Standard Deviation 9.14
|
SECONDARY outcome
Timeframe: Timepoint 2 (week 7 of study participation).Measures symptoms of fatigue, total scores range from 9-63, higher scores indicate worse outcomes
Outcome measures
| Measure |
Control Group
n=25 Participants
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
n=23 Participants
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
|
|---|---|---|
|
Fatigue Severity Scale (FSS)
|
50.60 units on a scale
Standard Deviation 8.74
|
47.30 units on a scale
Standard Deviation 10.12
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place