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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188460
• Other study ID #: 2009902
• Status: Completed
• Phase: N/A
• First received: August 19, 2010
• Last updated: August 10, 2017
• Start date: April 2010
• Est. completion date: March 2012

Study information

• Verified date: August 2017
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Pain
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Rehabilitation Centre	Ottawa	Ontario
Canada	The Ottawa Hospital, Pain Clinic	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	The Ottawa Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Timepoint 2 (week 7 of study participation)
Primary	Sleep Diary- Total Sleep Time	Measures: Total Sleep Time in hours, higher scores indicate better outcomes	Timepoint 2 (week 7 of study participation).
Primary	Sleep Diary- Time to Fall Asleep	Measures: Time to Fall Asleep in minutes, higher scores indicate worse outcomes	Timepoint 2 (week 7 of study participation).
Primary	Sleep Diary- Number of Nocturnal Awakenings	Measures: Number of Nocturnal Awakenings, higher scores indicate worse outcomes	Timepoint 2 (week 7 of study participation).
Primary	Sleep Diary- Sleep Efficiency	Measures: Sleep Efficiency (percentage)- higher scores indicate better outcomes	Timepoint 2 (week 7 of study participation).
Primary	Sleep Diary- Sleep Quality	Measures: Sleep Quality (units on a scale from 0-10), higher scores indicate better outcomes	Timepoint 2 (week 7 of study participation).
Secondary	Pain Severity Rating	Measures pain severity, rated on scale from 0-10, total scores range from 0-40, higher scores indicate worse outcomes	Timepoint 2 (week 7 of study participation).
Secondary	Pain Disability Index (PDI)	Measures pain disability impact on various life domains, scores range from 0-70, higher scores indicate worse outcomes	Timepoint 2 (week 7 of study participation).
Secondary	Hospital Anxiety and Depression Scale (HADS)	Measures symptoms of depression and anxiety, total scores range from 0-42, higher scores indicate worse outcomes	Timepoint 2 (week 7 of study participation).
Secondary	Pre-Sleep Arousal Scale (PSAS)	Measures pre-sleep hyperarousal, total scores range from 16-80, higher scores indicate worse outcomes	Timepoint 2 (week 7 of study participation).
Secondary	Fatigue Severity Scale (FSS)	Measures symptoms of fatigue, total scores range from 9-63, higher scores indicate worse outcomes	Timepoint 2 (week 7 of study participation).