NCT01188460

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
6 years until next milestone

Results Posted

Study results publicly available

February 19, 2018

Completed
Last Updated

February 19, 2018

Status Verified

August 1, 2017

Enrollment Period

1.8 years

First QC Date

August 19, 2010

Results QC Date

January 20, 2017

Last Update Submit

August 10, 2017

Conditions

InsomniaChronic Pain

Keywords

InsomniaChronic pain

Outcome Measures

Primary Outcomes (6)

  • 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)

  • Sleep Diary- Total Sleep Time

    Measures: Total Sleep Time in hours, higher scores indicate better outcomes

    Timepoint 2 (week 7 of study participation).

  • 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).

  • Sleep Diary- Number of Nocturnal Awakenings

    Measures: Number of Nocturnal Awakenings, higher scores indicate worse outcomes

    Timepoint 2 (week 7 of study participation).

  • Sleep Diary- Sleep Efficiency

    Measures: Sleep Efficiency (percentage)- higher scores indicate better outcomes

    Timepoint 2 (week 7 of study participation).

  • 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 Outcomes (5)

  • Pain Severity Rating

    Timepoint 2 (week 7 of study participation).

  • Pain Disability Index (PDI)

    Timepoint 2 (week 7 of study participation).

  • Hospital Anxiety and Depression Scale (HADS)

    Timepoint 2 (week 7 of study participation).

  • Pre-Sleep Arousal Scale (PSAS)

    Timepoint 2 (week 7 of study participation).

  • Fatigue Severity Scale (FSS)

    Timepoint 2 (week 7 of study participation).

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Receive one weekly telephone follow-up call per week to monitor sleep progress, complete 7 weeks of sleep diaries only (sleep diary measures Total Sleep Time in hours, Time to Fall Asleep in minutes, Number of Nocturnal Awakenings, Sleep Efficiency as a percentage, and Sleep Quality as units on a scale), complete questionnaires at three study timepoints

Behavioral: Sleep diary

Experimental Group

EXPERIMENTAL

Receive one weekly telephone call to monitor sleep progress, complete 7 weeks of sleep diaries (sleep diary measures Total Sleep Time in hours, Time to Fall Asleep in minutes, Number of Nocturnal Awakenings, Sleep Efficiency as a percentage, and Sleep Quality as units on a scale), implement one chapter per week of self-help manual for insomnia over 7 weeks at home, complete questionnaires at three study timepoints

Behavioral: Self-help manual for insomniaBehavioral: Sleep diary

Interventions

Self-help manual for insomniaBEHAVIORAL

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

Also known as: Intervention Group
Experimental Group
Sleep diaryBEHAVIORAL
Control GroupExperimental Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 65 years of age
  • Not in state of crisis
  • Able to read and understand English
  • Experiences sleep difficulties or insomnia
  • Has chronic pain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Ottawa Hospital, Pain Clinic

Ottawa, Ontario, K1H 8L6, Canada

Location

The Ottawa Hospital Rehabilitation Centre

Ottawa, Ontario, K1H 8M2, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersChronic Pain

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Keith Wilson
Organization
OHRI
kewilson@toh.ca

Study Officials

  • Keith E Wilson, PhD

    The Ottawa Hospital Rehabilitation Centre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2010

First Posted

August 25, 2010

Study Start

April 1, 2010

Primary Completion

January 1, 2012

Study Completion

March 1, 2012

Last Updated

February 19, 2018

Results First Posted

February 19, 2018

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)