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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01188460

Enrollment

Registered

2010-08-25

Start date

2010-04-30

Completion date

2012-03-31

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Chronic Pain

Keywords

Insomnia, Chronic pain

Brief 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.

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.

Interventions

BEHAVIORALSelf-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

BEHAVIORALSleep diary

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Insomnia Severity Index (ISI)	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	Timepoint 2 (week 7 of study participation).	Measures: Total Sleep Time in hours, higher scores indicate better outcomes
Sleep Diary- Time to Fall Asleep	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	Timepoint 2 (week 7 of study participation).	Measures: Number of Nocturnal Awakenings, higher scores indicate worse outcomes
Sleep Diary- Sleep Efficiency	Timepoint 2 (week 7 of study participation).	Measures: Sleep Efficiency (percentage)- higher scores indicate better outcomes
Sleep Diary- Sleep Quality	Timepoint 2 (week 7 of study participation).	Measures: Sleep Quality (units on a scale from 0-10), higher scores indicate better outcomes

Secondary

Measure	Time frame	Description
Pain Severity Rating	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
Pain Disability Index (PDI)	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
Hospital Anxiety and Depression Scale (HADS)	Timepoint 2 (week 7 of study participation).	Measures symptoms of depression and anxiety, total scores range from 0-42, higher scores indicate worse outcomes
Pre-Sleep Arousal Scale (PSAS)	Timepoint 2 (week 7 of study participation).	Measures pre-sleep hyperarousal, total scores range from 16-80, higher scores indicate worse outcomes
Fatigue Severity Scale (FSS)	Timepoint 2 (week 7 of study participation).	Measures symptoms of fatigue, total scores range from 9-63, higher scores indicate worse outcomes

Countries

Canada

Participant flow

Participants by arm

Arm	Count
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	25
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	23
Total	48

Baseline characteristics

Characteristic	Control Group	Experimental Group	Total
Age, Continuous	44.29 years STANDARD_DEVIATION 9.55	47.96 years STANDARD_DEVIATION 10.21	46.09 years STANDARD_DEVIATION 9.94
Sex: Female, Male Female	14 Participants	15 Participants	29 Participants
Sex: Female, Male Male	11 Participants	8 Participants	19 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 25	0 / 23
serious Total, serious adverse events	0 / 25	0 / 23

Outcome results

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

Time frame: Timepoint 2 (week 7 of study participation)

Arm	Measure	Value (MEAN)	Dispersion
Control Group	Insomnia Severity Index (ISI)	19.84 units on a scale	Standard Deviation 4.14
Experimental Group	Insomnia Severity Index (ISI)	16.04 units on a scale	Standard Deviation 5.16

Primary