A Comparison of MBSR and CBT for the Treatment of Insomnia in Cancer
I-CAN SLEEP
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
1 other identifier
interventional
111
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Sep 2008
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 12, 2011
CompletedFirst Posted
Study publicly available on registry
April 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJune 19, 2013
June 1, 2013
2.8 years
April 12, 2011
June 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Insomnia Severity from baseline to 3 months
Baseline, Post-Treatment, 3 month follow up
Secondary Outcomes (6)
Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months
Baseline, Post Treatment, 3 month follow up
Change in subjective measures of sleep using Sleep Diaries from baseline to 3 months
Baseline (one week), During treatment (7 weeks), Post Treatment (1 week), 3 month Follow up (1 week)
Change in Pittsburgh Sleep Quality Index scores from baseline to 3 months
Baseline, Post Treatment, 3 month follow up
Change in Dysfunctional Attitudes and Beliefs about Sleep Scale scores from baseline to 3 months
Baseline, Post Treatment, 3 month folllow up
Change in Calgary Symptoms of Stress Inventory scores from baseline to 3 months
Baseline, Post Treatment, 3 month folllow up
- +1 more secondary outcomes
Study Arms (2)
Cognitive Behavior Therapy
EXPERIMENTALCognitive Behavior Therapy for insomnia consists of stimulus control therapy, sleep restriction therapy, cognitive therapy and relaxation.
Mindfulness-Based Stress Reduction
EXPERIMENTALThe 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.
Interventions
This intervention is provided over the course of eight, weekly, 90 minute sessions, plus one 6 hour silent retreat.
This treatment is delivered to small groups over the course of 8 weekly, 90 minute sessions
Eligibility Criteria
You may qualify if:
- English speaking
- Non metastatic cancer
- month post chemotherapy/radiation treatment (hormone treatment okay)
- Diagnosis of Primary or Secondary Insomnia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Canadian Cancer Society (CCS)collaborator
Study Sites (1)
Tom Baker Cancer Centre-Holy Cross Site
Calgary, Alberta, T2S 3C1, Canada
Related Publications (2)
Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
PMID: 41170811DERIVEDGarland 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.
PMID: 24395850DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tavis S Campbell, PhD
University of Calgary
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
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Psychology
Study Record Dates
First Submitted
April 12, 2011
First Posted
April 14, 2011
Study Start
September 1, 2008
Primary Completion
July 1, 2011
Study Completion
July 1, 2012
Last Updated
June 19, 2013
Record last verified: 2013-06