Clinical trial NCT01335776: A Comparison of MBSR and CBT for the Treatment of Insomnia in Cancer
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
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Insomnia
Keywords: Mindfulness-Based Stress Reduction
Cognitive Behavior Therapy
Actigraphy
Noninferiority
MBSR
CBT-I
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2011-04-14
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Insomnia Severity from baseline to 3 months
timeFrame: Baseline, Post-Treatment, 3 month follow up
Secondary outcomes:
measure: Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months
timeFrame: Baseline, Post Treatment, 3 month follow up
measure: Change in subjective measures of sleep using Sleep Diaries from baseline to 3 months
timeFrame: Baseline (one week), During treatment (7 weeks), Post Treatment (1 week), 3 month Follow up (1 week)
measure: Change in Pittsburgh Sleep Quality Index scores from baseline to 3 months
timeFrame: Baseline, Post Treatment, 3 month follow up
measure: Change in Dysfunctional Attitudes and Beliefs about Sleep Scale scores from baseline to 3 months
timeFrame: Baseline, Post Treatment, 3 month folllow up
measure: Change in Calgary Symptoms of Stress Inventory scores from baseline to 3 months
timeFrame: Baseline, Post Treatment, 3 month folllow up
measure: Change in Five Facet Mindfulness Questionnaire scores from baseline to 3 months
timeFrame: Baseline, Post Treatment, 3 month folllow up
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre-Holy Cross Site
state: Alberta
Study officials:
affiliation: University of Calgary
name: Tavis S Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.