Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Change in Insomnia Severity from baseline to 3 months
Outcome Time Frame:
Baseline, Post-Treatment, 3 month follow up
Safety Issue:
No
Principal Investigator
Tavis S Campbell, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Calgary
Authority:
Canada: Canadian Institutes of Health Research
Study ID:
RT735639
NCT ID:
NCT01335776
Start Date:
September 2008
Completion Date:
July 2012
Related Keywords:
- Cancer
- Insomnia
- Mindfulness-Based Stress Reduction
- Cognitive Behavior Therapy
- Actigraphy
- Noninferiority
- MBSR
- CBT-I
- Sleep Initiation and Maintenance Disorders