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

Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335776
• Other study ID #: RT735639
• Status: Completed
• Phase: N/A
• First received: April 12, 2011
• Last updated: June 17, 2013
• Start date: September 2008
• Est. completion date: July 2012

Study information

• Verified date: June 2013
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: July 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Insomnia

Intervention

Behavioral:
• Mindfulness-Based Stress Reduction
This intervention is provided over the course of eight, weekly, 90 minute sessions, plus one 6 hour silent retreat.
• Cognitive Behavior Therapy
This treatment is delivered to small groups over the course of 8 weekly, 90 minute sessions

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre-Holy Cross Site	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Canadian Cancer Society Research Institute (CCSRI)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insomnia Severity from baseline to 3 months		Baseline, Post-Treatment, 3 month follow up	No
Secondary	Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months		Baseline, Post Treatment, 3 month follow up	No
Secondary	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)	No
Secondary	Change in Pittsburgh Sleep Quality Index scores from baseline to 3 months		Baseline, Post Treatment, 3 month follow up	No
Secondary	Change in Dysfunctional Attitudes and Beliefs about Sleep Scale scores from baseline to 3 months		Baseline, Post Treatment, 3 month folllow up	No
Secondary	Change in Calgary Symptoms of Stress Inventory scores from baseline to 3 months		Baseline, Post Treatment, 3 month folllow up	No
Secondary	Change in Five Facet Mindfulness Questionnaire scores from baseline to 3 months		Baseline, Post Treatment, 3 month folllow up	No

External Links

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