N/A
Completed N=48
A Cognitive-Behaviour Therapy (CBT) Self-Management Approach for Insomnia in Chronic Pain: A Randomized Control Trial
Source: ClinicalTrials.gov NCT01188460 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcomePrimary: Insomnia Severity Index (ISI) — 19.84; 16.04 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity Index (ISI) |
19.84; 16.04 | — |
| PRIMARY Sleep Diary- Total Sleep Time |
5.34; 5.46 | — |
| PRIMARY Sleep Diary- Time to Fall Asleep |
0.46; 0.35 | — |
| PRIMARY Sleep Diary- Number of Nocturnal Awakenings |
3; 3 | — |
| PRIMARY Sleep Diary- Sleep Efficiency |
63.06; 67.09 | — |
| PRIMARY Sleep Diary- Sleep Quality |
4; 4 | — |
| SECONDARY Pain Severity Rating |
27.96; 25.35 | — |
| SECONDARY Pain Disability Index (PDI) |
48.12; 46.13 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) |
22.08; 19.43 | — |
| SECONDARY Pre-Sleep Arousal Scale (PSAS) |
44.84; 35.43 | — |
| SECONDARY Fatigue Severity Scale (FSS) |
50.60; 47.30 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01188460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.