A Cognitive-Behaviour Therapy (CBT) Self-Management Approach for Insomnia in Chronic Pain: A Randomized Control Trial
Condition: Insomnia; Chronic Pain
MeSH terms: Sleep Initiation and Maintenance Disorders; Chronic Pain
Study type: Interventional

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.
    

Intervention name(s): Self-help manual for insomnia; Sleep diary
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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
Other intervention name(s): Intervention Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Insomnia; Chronic pain