A Comparison of MBSR and CBT for the Treatment of Insomnia in Cancer (I-CAN SLEEP)
This study has been completed.
Sponsor:
University of Calgary
Collaborator:
Canadian Cancer Society
Information provided by (Responsible Party):
Tavis S. Campbell, University of Calgary
ClinicalTrials.gov Identifier:
NCT01335776
First received: April 12, 2011
Last updated: January 31, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cancer Insomnia |
Behavioral: Mindfulness-Based Stress Reduction Behavioral: Cognitive Behavior Therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Calgary:
Primary Outcome Measures:
- Change in Insomnia Severity from baseline to 3 months [ Time Frame: Baseline, Post-Treatment, 3 month follow up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months [ Time Frame: Baseline, Post Treatment, 3 month follow up ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- Change in Pittsburgh Sleep Quality Index scores from baseline to 3 months [ Time Frame: Baseline, Post Treatment, 3 month follow up ] [ Designated as safety issue: No ]
- Change in Dysfunctional Attitudes and Beliefs about Sleep Scale scores from baseline to 3 months [ Time Frame: Baseline, Post Treatment, 3 month folllow up ] [ Designated as safety issue: No ]
- Change in Calgary Symptoms of Stress Inventory scores from baseline to 3 months [ Time Frame: Baseline, Post Treatment, 3 month folllow up ] [ Designated as safety issue: No ]
- Change in Five Facet Mindfulness Questionnaire scores from baseline to 3 months [ Time Frame: Baseline, Post Treatment, 3 month folllow up ] [ Designated as safety issue: No ]
| Enrollment: | 111 |
| Study Start Date: | September 2008 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cogntive Behavior Therapy
Cognitive Behavior Therapy for insomnia consists of stimulus control therapy, sleep restriction therapy, cognitive therapy and relaxation.
|
Behavioral: Cognitive Behavior Therapy
This treatment is delivered to small groups over the course of 8 weekly, 90 minute sessions
Other Name: CBT-I
|
|
Experimental: Mindfulness-Based Stress Reduction
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.
|
Behavioral: Mindfulness-Based Stress Reduction
This intervention is provided over the course of eight, weekly, 90 minute sessions, plus one 6 hour silent retreat.
Other Name: MBSR
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335776
Locations
| Canada, Alberta | |
| Tom Baker Cancer Centre-Holy Cross Site | |
| Calgary, Alberta, Canada, T2S 3C1 | |
Sponsors and Collaborators
University of Calgary
Canadian Cancer Society
Investigators
| Principal Investigator: | Tavis S Campbell, PhD | University of Calgary |
More Information
Additional Information:
No publications provided
| Responsible Party: | Tavis S. Campbell, Associate Professor of Psychology, University of Calgary |
| ClinicalTrials.gov Identifier: | NCT01335776 History of Changes |
| Other Study ID Numbers: | RT735639 |
| Study First Received: | April 12, 2011 |
| Last Updated: | January 31, 2013 |
| Health Authority: | Canada: Canadian Institutes of Health Research |
Keywords provided by University of Calgary:
|
Mindfulness-Based Stress Reduction Cognitive Behavior Therapy Actigraphy |
Noninferiority MBSR CBT-I |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013