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A Comparison of MBSR and CBT for the Treatment of Insomnia in Cancer (I-CAN SLEEP)

Primary Purpose

Cancer, Insomnia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction
Cognitive Behavior Therapy
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Mindfulness-Based Stress Reduction, Cognitive Behavior Therapy, Actigraphy, Noninferiority, MBSR, CBT-I

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • English speaking
  • Non metastatic cancer
  • 1 month post chemotherapy/radiation treatment (hormone treatment okay)
  • Diagnosis of Primary or Secondary Insomnia

Exclusion Criteria:

  • Presence of another sleep disorder
  • Presence of another Axis I diagnosis (not in remission)
  • Inability to attend at least 5 out of the 8 treatment sessions
  • Randomization Refusal
  • Previous participation in CBT-I or MBSR
  • Shift work

Sites / Locations

  • Tom Baker Cancer Centre-Holy Cross Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cognitive Behavior Therapy

Mindfulness-Based Stress Reduction

Arm Description

Cognitive Behavior Therapy for insomnia consists of stimulus control therapy, sleep restriction therapy, cognitive therapy and relaxation.

The program consists of three primary components: theoretical material related to relaxation, meditation, and the mind-body connection; experiential practice of meditation and yoga and home based practice; group process focused on problem solving and support.

Outcomes

Primary Outcome Measures

Change in Insomnia Severity from baseline to 3 months

Secondary Outcome Measures

Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months
Change in subjective measures of sleep using Sleep Diaries from baseline to 3 months
Change in Pittsburgh Sleep Quality Index scores from baseline to 3 months
Change in Dysfunctional Attitudes and Beliefs about Sleep Scale scores from baseline to 3 months
Change in Calgary Symptoms of Stress Inventory scores from baseline to 3 months
Change in Five Facet Mindfulness Questionnaire scores from baseline to 3 months

Full Information

First Posted
April 12, 2011
Last Updated
June 17, 2013
Sponsor
University of Calgary
Collaborators
Canadian Cancer Society (CCS)
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1. Study Identification

Unique Protocol Identification Number
NCT01335776
Brief Title
A Comparison of MBSR and CBT for the Treatment of Insomnia in Cancer
Acronym
I-CAN SLEEP
Official Title
An Objective Comparison of Cognitive Behavioral Therapy and Mindfulness-based Stress Reduction for the Treatment of Insomnia in Cancer Survivors Using Wrist Actigraphy: A Randomized Noninferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Canadian Cancer Society (CCS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Sleep disturbance in cancer patients is often overlooked despite its documented high prevalence and negative impact. There are few empirically validated non-pharmacological treatments for insomnia and many patients are unwilling to rely on sleeping medications. This study will determine whether Mindfulness-Based Stress Reduction (a program that teaches meditation and yoga) produces equivalent results with the additional benefits of reduced stress and mood disturbance, to an already established treatment for insomnia, Cognitive-Behavioral Therapy. This will allow for the expansion of treatment options for insomnia beyond what is currently available and improve quality of life for millions of cancer survivors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Insomnia
Keywords
Mindfulness-Based Stress Reduction, Cognitive Behavior Therapy, Actigraphy, Noninferiority, MBSR, CBT-I

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavior Therapy
Arm Type
Experimental
Arm Description
Cognitive Behavior Therapy for insomnia consists of stimulus control therapy, sleep restriction therapy, cognitive therapy and relaxation.
Arm Title
Mindfulness-Based Stress Reduction
Arm Type
Experimental
Arm Description
The program consists of three primary components: theoretical material related to relaxation, meditation, and the mind-body connection; experiential practice of meditation and yoga and home based practice; group process focused on problem solving and support.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction
Other Intervention Name(s)
MBSR
Intervention Description
This intervention is provided over the course of eight, weekly, 90 minute sessions, plus one 6 hour silent retreat.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy
Other Intervention Name(s)
CBT-I
Intervention Description
This treatment is delivered to small groups over the course of 8 weekly, 90 minute sessions
Primary Outcome Measure Information:
Title
Change in Insomnia Severity from baseline to 3 months
Time Frame
Baseline, Post-Treatment, 3 month follow up
Secondary Outcome Measure Information:
Title
Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months
Time Frame
Baseline, Post Treatment, 3 month follow up
Title
Change in subjective measures of sleep using Sleep Diaries from baseline to 3 months
Time Frame
Baseline (one week), During treatment (7 weeks), Post Treatment (1 week), 3 month Follow up (1 week)
Title
Change in Pittsburgh Sleep Quality Index scores from baseline to 3 months
Time Frame
Baseline, Post Treatment, 3 month follow up
Title
Change in Dysfunctional Attitudes and Beliefs about Sleep Scale scores from baseline to 3 months
Time Frame
Baseline, Post Treatment, 3 month folllow up
Title
Change in Calgary Symptoms of Stress Inventory scores from baseline to 3 months
Time Frame
Baseline, Post Treatment, 3 month folllow up
Title
Change in Five Facet Mindfulness Questionnaire scores from baseline to 3 months
Time Frame
Baseline, Post Treatment, 3 month folllow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English speaking Non metastatic cancer 1 month post chemotherapy/radiation treatment (hormone treatment okay) Diagnosis of Primary or Secondary Insomnia Exclusion Criteria: Presence of another sleep disorder Presence of another Axis I diagnosis (not in remission) Inability to attend at least 5 out of the 8 treatment sessions Randomization Refusal Previous participation in CBT-I or MBSR Shift work
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tavis S Campbell, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom Baker Cancer Centre-Holy Cross Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2S 3C1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24395850
Citation
Garland SN, Carlson LE, Stephens AJ, Antle MC, Samuels C, Campbell TS. Mindfulness-based stress reduction compared with cognitive behavioral therapy for the treatment of insomnia comorbid with cancer: a randomized, partially blinded, noninferiority trial. J Clin Oncol. 2014 Feb 10;32(5):449-57. doi: 10.1200/JCO.2012.47.7265. Epub 2014 Jan 6.
Results Reference
derived
Links:
URL
http://www.icansleep.ca
Description
Related Info

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A Comparison of MBSR and CBT for the Treatment of Insomnia in Cancer

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