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

• Sleep Diary [ Time Frame: Timepoint 2 (week 7 of study participation). ] [ Designated as safety issue: No ]
  Measures Time in Bed, Total Sleep Time, Sleep Efficiency, Time to Fall Asleep, Total Number of Awakenings, and Sleep Quality
  
  
• Insomnia Severity Index (ISI) [ Time Frame: Timepoint 2 (week 7 of study participation) ] [ Designated as safety issue: No ]
  Measures insomnia symptoms
  
  

• Pain Severity rating [ Time Frame: Timepoint 2 (week 7 of study participation). ] [ Designated as safety issue: No ]
  Measures pain severity
  
  
• Pain Disability Index (PDI) [ Time Frame: Timepoint 2 (week 7 of study participation). ] [ Designated as safety issue: No ]
  Measures pain disability impact on various life domains
  
  
• Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Timepoint 2 (week 7 of study participation). ] [ Designated as safety issue: Yes ]
  Measures symptoms of depression and anxiety
  
  
• Pre-Sleep Arousal Scale (PSAS) [ Time Frame: Timepoint 2 (week 7 of study participation). ] [ Designated as safety issue: No ]
  Measures pre-sleep hyperarousal
  
  
• Fatigue Severity Scale (FSS) [ Time Frame: Timepoint 2 (week 7 of study participation). ] [ Designated as safety issue: No ]
  Measures symptoms of fatigue
  
  

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.