InsomniaNCT01188460
A Cognitive-Behaviour Therapy (CBT) Self-Management Approach for Insomnia in Chronic Pain: A Randomized Control Trial
A study testing Self-help manual for insomnia and Sleep diary in people with Insomnia and Chronic Pain, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial summary
This study will test the impact of a cognitive-behavioural self-management approach for the management of insomnia among patients with chronic pain. This self-management approach consists of a manual describing cognitive behavioural techniques for the management of insomnia. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Chronic Pain
- What is being tested?
- Self-help manual for insomnia and Sleep diary
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2010to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age
- Not in state of crisis
- Able to read and understand English
- Experiences sleep difficulties or insomnia
- Has chronic pain
Who cannot join
- Under 18 or over 65 years of age
- In a state of crisis
- Does not read or understand English
- Does not experience sleep difficulties or insomnia
- Does not have chronic pain
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Ottawa Hospital, Pain Clinic
Ottawa, Ontario, K1H 8L6
The Ottawa Hospital Rehabilitation Centre
Ottawa, Ontario, K1H 8M2
About this study
This study will test the impact of a cognitive-behavioural self-management approach for the management of insomnia among patients with chronic pain. This self-management approach consists of a manual describing cognitive behavioural techniques for the management of insomnia. In terms of primary outcomes, it is anticipated that there would be improvements in sleep-related dimensions such as sleep quality, sleep efficiency, and night-time awakenings in the sample group receiving a copy of the self-help manual intervention to be implemented by participants in their home (intervention group), relative to the group receiving treatment as usual (control group). In terms of secondary outcomes, it is anticipated that the intervention group will show improvements in mood, fatigue, pain severity, and pain-related disability relative to the control group. The tertiary outcome variable of pre-sleep arousal is anticipated to have a moderating or mediating relationship with the sleep variables investigated.
Read the detailed description
In summary therefore, insomnia and other sleep difficulties have been reported to frequently occur in conjunction with other medical or psychiatric disorders, however insomnia co-occurring with other medical or psychiatric conditions has received less attention relative to primary insomnia with no such concurrent conditions (e.g., Lichstein, 2006; McCrae, \& Lichstein, 2001; Taylor, Mallory, Lichstein, Durrence, Riedel, \& Bush, 2007). In chronic pain, there have not been many well-controlled studies involving insomnia existing with a concurrent chronically painful condition. Research thus far has found multi-component cognitive-behavioural approaches to be successful in treating primary insomnia, and there have been some studies applying these approaches in the context of insomnia and concurrent medical conditions (Currie, Wilson, Pontefract, \& deLaplante, 2000; Morin, 1993). Based on Morin's work (Morin, 1993; Morin, Beaulieu-Bonneau, LeBlanc, \& Savard, 2005) involving a cognitive-behaviour therapy (CBT) protocol for patients with sleep problems related to chronic pain, a self-help format of such an intervention has also been developed (Currie \& Wilson, 1997). However, this has thus far only been delivered within a group-based treatment programme (Currie, 1998; Currie \& Wilson, 1997; Currie, Wilson, Pontefract, \& deLaplante, 2000). From this context, and building on a prior study involving a group treatment format (Currie, 1998; Currie, Wilson, Pontefract, \& deLaplante, 2000), the usefulness of a manualized self-management approach in manageing insomnia will be investigated, including the impact of this approach with regard to other salient measures of improved functioning (such as pain severity or pain-related disability) for individuals with chronic pain. The proposed study will involve a randomized control trial of this self-help treatment strategy for comorbid insomnia in chronically painful medical conditions among an adult outpatient sample at a hospital rehabilitation centre and pain clinic. This study thus seeks to investigate how successful a cognitive-behaviour therapy (CBT) self-help management approach is for manageing insomnia amongst people with chronic pain. Given the public health implications of the relationship of poor sleep to quality of life (e.g., Morin, Stone, McDonald, \& Jones, 1994; Quesnel, Savard, Simard, Ivers, \& Morin, 2003), a self-management approach to insomnia in the context of chronic pain may offer an accessible and cost-effective treatment option.
The following hypotheses will be tested:
The first hypothesis predicts that participants in the intervention group will show changes in their scores on psychological measures in terms of greater improvements in sleep-related dimensions, in comparison with controls between the baseline and post-treatment periods.
The second hypothesis predicts that participants in the intervention group will show changes in their scores on psychological measures in terms of lower levels of anxiety, depression, fatigue, pain severity, and pain-related disability, in comparison with controls between the baseline and post-treatment periods. These secondary outcome variables are not directly targeted by the intervention, however it is proposed that if improvements in sleep are experienced, there would be subsequent improvements in the variables of mood, fatigue, pain severity, and pain-related disability among chronic pain patients who experience insomnia.
The third hypothesis predicts that the variable of pre-sleep arousal will have a moderating or mediating influence on the sleep-related variables (which will be the primary outcome variables). The moderating or mediating variable of pre-sleep arousal is proposed to assess dimensions related to sleep that are not tapped into by the primary outcome, sleep-related variables, but that may be of salience in the context of insomnia that is comorbid with chronically painful conditions.
- Conditions
- Insomnia, Chronic Pain
- Being tested
- Self-help manual for insomnia, Sleep diary
- Keywords
- Insomnia, Chronic pain
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-help manual for insomniaBehavioural
Also called Intervention Group
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 diaryBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only (sleep diary measures Total Sleep Time in hours, Time to Fall Asleep in minutes, Number of Nocturnal Awakenings, Sleep Efficiency as a percentage, and Sleep Quality as units on a scale), complete questionnaires at three study timepoints Receives: Behavioral: Sleep diary |
| Experimental Group | Experimental | Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries (sleep diary measures Total Sleep Time in hours, Time to Fall Asleep in minutes, Number of Nocturnal Awakenings, Sleep Efficiency as a percentage, and Sleep Quality as units on a scale), implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints Receives: Behavioral: Self-help manual for insomnia; Behavioral: Sleep diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
Measures insomnia symptoms, scores range from 0-28 with higher scores (ranging from 15-28) indicating clinical insomnia and therefore worse outcomes
Measured: Timepoint 2 (week 7 of study participation)
Sleep Diary- Total Sleep Time
Measures:
Total Sleep Time in hours, higher scores indicate better outcomes
Measured: Timepoint 2 (week 7 of study participation).
Sleep Diary- Time to Fall Asleep
Measures:
Time to Fall Asleep in minutes, higher scores indicate worse outcomes
Measured: Timepoint 2 (week 7 of study participation).
Sleep Diary- Number of Nocturnal Awakenings
Measures:
Number of Nocturnal Awakenings, higher scores indicate worse outcomes
Measured: Timepoint 2 (week 7 of study participation).
Sleep Diary- Sleep Efficiency
Measures:
Sleep Efficiency (percentage)- higher scores indicate better outcomes
Measured: Timepoint 2 (week 7 of study participation).
Sleep Diary- Sleep Quality
Measures:
Sleep Quality (units on a scale from 0-10), higher scores indicate better outcomes
Measured: Timepoint 2 (week 7 of study participation).
Secondary outcomes (5)
Pain Severity Rating
Measures pain severity, rated on scale from 0-10, total scores range from 0-40, higher scores indicate worse outcomes
Measured: Timepoint 2 (week 7 of study participation).
Pain Disability Index (PDI)
Measures pain disability impact on various life domains, scores range from 0-70, higher scores indicate worse outcomes
Measured: Timepoint 2 (week 7 of study participation).
Hospital Anxiety and Depression Scale (HADS)
Measures symptoms of depression and anxiety, total scores range from 0-42, higher scores indicate worse outcomes
Measured: Timepoint 2 (week 7 of study participation).
Pre-Sleep Arousal Scale (PSAS)
Measures pre-sleep hyperarousal, total scores range from 16-80, higher scores indicate worse outcomes
Measured: Timepoint 2 (week 7 of study participation).
Fatigue Severity Scale (FSS)
Measures symptoms of fatigue, total scores range from 9-63, higher scores indicate worse outcomes
Measured: Timepoint 2 (week 7 of study participation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital
- Responsible party
- Sponsor
- Investigators
- Keith E Wilson, PhD, Principal investigator, The Ottawa Hospital Rehabilitation Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188460
- Sponsor's protocol ID
- 2009902
- Status last verified
- Aug 2017
- First submitted
- 19 Aug 2010
- Last updated
- 19 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cognitive-Behaviour Therapy (CBT) Self-Management Approach for Insomnia in Chronic Pain: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01188460
- Acronym / sponsor ID
- 2009902
- Conditions
- Insomnia, Chronic Pain
- Keywords
- Insomnia, Chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Ottawa Hospital
- Study start
- Apr 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 25 Aug 2010 (estimated)
- Results
- Posted 19 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the impact of a cognitive-behavioural self-management approach for the management of insomnia among patients with chronic pain. This self-management approach consists of a manual describing cognitive behavioural techniques for the management of insomnia. In terms of primary outcomes, it is anticipated that there would be improvements in sleep-related dimensions such as sleep quality, sleep efficiency, and night-time awakenings in the sample group receiving a copy of the self-help manual intervention to be implemented by participants in their home (intervention group), relative to the group receiving treatment as usual (control group). In terms of secondary outcomes, it is anticipated that the intervention group will show improvements in mood, fatigue, pain severity, and pain-related disability relative to the control group. The tertiary outcome variable of pre-sleep arousal is anticipated to have a moderating or mediating relationship with the sleep variables investigated.
Detailed description
In summary therefore, insomnia and other sleep difficulties have been reported to frequently occur in conjunction with other medical or psychiatric disorders, however insomnia co-occurring with other medical or psychiatric conditions has received less attention relative to primary insomnia with no such concurrent conditions (e.g., Lichstein, 2006; McCrae, \& Lichstein, 2001; Taylor, Mallory, Lichstein, Durrence, Riedel, \& Bush, 2007). In chronic pain, there have not been many well-controlled studies involving insomnia existing with a concurrent chronically painful condition. Research thus far has found multi-component cognitive-behavioural approaches to be successful in treating primary insomnia, and there have been some studies applying these approaches in the context of insomnia and concurrent medical conditions (Currie, Wilson, Pontefract, \& deLaplante, 2000; Morin, 1993). Based on Morin's work (Morin, 1993; Morin, Beaulieu-Bonneau, LeBlanc, \& Savard, 2005) involving a cognitive-behaviour therapy (CBT) protocol for patients with sleep problems related to chronic pain, a self-help format of such an intervention has also been developed (Currie \& Wilson, 1997). However, this has thus far only been delivered within a group-based treatment programme (Currie, 1998; Currie \& Wilson, 1997; Currie, Wilson, Pontefract, \& deLaplante, 2000). From this context, and building on a prior study involving a group treatment format (Currie, 1998; Currie, Wilson, Pontefract, \& deLaplante, 2000), the usefulness of a manualized self-management approach in manageing insomnia will be investigated, including the impact of this approach with regard to other salient measures of improved functioning (such as pain severity or pain-related disability) for individuals with chronic pain. The proposed study will involve a randomized control trial of this self-help treatment strategy for comorbid insomnia in chronically painful medical conditions among an adult outpatient sample at a hospital rehabilitation centre and pain clinic. This study thus seeks to investigate how successful a cognitive-behaviour therapy (CBT) self-help management approach is for manageing insomnia amongst people with chronic pain. Given the public health implications of the relationship of poor sleep to quality of life (e.g., Morin, Stone, McDonald, \& Jones, 1994; Quesnel, Savard, Simard, Ivers, \& Morin, 2003), a self-management approach to insomnia in the context of chronic pain may offer an accessible and cost-effective treatment option.
The following hypotheses will be tested:
The first hypothesis predicts that participants in the intervention group will show changes in their scores on psychological measures in terms of greater improvements in sleep-related dimensions, in comparison with controls between the baseline and post-treatment periods.
The second hypothesis predicts that participants in the intervention group will show changes in their scores on psychological measures in terms of lower levels of anxiety, depression, fatigue, pain severity, and pain-related disability, in comparison with controls between the baseline and post-treatment periods. These secondary outcome variables are not directly targeted by the intervention, however it is proposed that if improvements in sleep are experienced, there would be subsequent improvements in the variables of mood, fatigue, pain severity, and pain-related disability among chronic pain patients who experience insomnia.
The third hypothesis predicts that the variable of pre-sleep arousal will have a moderating or mediating influence on the sleep-related variables (which will be the primary outcome variables). The moderating or mediating variable of pre-sleep arousal is proposed to assess dimensions related to sleep that are not tapped into by the primary outcome, sleep-related variables, but that may be of salience in the context of insomnia that is comorbid with chronically painful conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Behavioral: Sleep diaryReceive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only (sleep diary measures Total Sleep Time in hours, Time to Fall Asleep in minutes, Number of Nocturnal Awakenings, Sleep Efficiency as a percentage, and Sleep Quality as units on a scale), complete questionnaires at three study timepoints |
| Experimental Group | Experimental | Behavioral: Self-help manual for insomnia, Behavioral: Sleep diaryReceive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries (sleep diary measures Total Sleep Time in hours, Time to Fall Asleep in minutes, Number of Nocturnal Awakenings, Sleep Efficiency as a percentage, and Sleep Quality as units on a scale), implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 65 years of age
- Not in state of crisis
- Able to read and understand English
- Experiences sleep difficulties or insomnia
- Has chronic pain
Key exclusion criteria (5 listed)
- Under 18 or over 65 years of age
- In a state of crisis
- Does not read or understand English
- Does not experience sleep difficulties or insomnia
- Does not have chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-help manual for insomniaAlso: Intervention GroupImplementation 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 | Behavioural | Experimental Group |
| Sleep diary | Behavioural | Control Group, Experimental Group |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: 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
Sleep Diary- Total Sleep Time
Time frame: Timepoint 2 (week 7 of study participation).
Measures: Total Sleep Time in hours, higher scores indicate better outcomes
Sleep Diary- Time to Fall Asleep
Time frame: Timepoint 2 (week 7 of study participation).
Measures: Time to Fall Asleep in minutes, higher scores indicate worse outcomes
Sleep Diary- Number of Nocturnal Awakenings
Time frame: Timepoint 2 (week 7 of study participation).
Measures: Number of Nocturnal Awakenings, higher scores indicate worse outcomes
Sleep Diary- Sleep Efficiency
Time frame: Timepoint 2 (week 7 of study participation).
Measures: Sleep Efficiency (percentage)- higher scores indicate better outcomes
Sleep Diary- Sleep Quality
Time frame: Timepoint 2 (week 7 of study participation).
Measures: Sleep Quality (units on a scale from 0-10), higher scores indicate better outcomes
5 secondary outcomes
Pain Severity Rating
Time frame: Timepoint 2 (week 7 of study participation).
Pain Disability Index (PDI)
Time frame: Timepoint 2 (week 7 of study participation).
Hospital Anxiety and Depression Scale (HADS)
Time frame: Timepoint 2 (week 7 of study participation).
Pre-Sleep Arousal Scale (PSAS)
Time frame: Timepoint 2 (week 7 of study participation).
Fatigue Severity Scale (FSS)
Time frame: Timepoint 2 (week 7 of study participation).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith E Wilson, PhD principal investigator
The Ottawa Hospital Rehabilitation Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-help manual for insomnia and Sleep diary in people with Insomnia and Chronic Pain, run by Ottawa Hospital Research Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: Timepoint 2 (week 7 of study participation)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018; AzTrials last refreshed its copy on 31 Oct 2026.