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I-CAN SLEEP: rationale and design of a non-inferiority RCT of Mindfulness-based Stress Reduction and Cognitive Behavioral Therapy for the treatment of Insomnia in CANcer survivors.

Contemporary clinical trials
September 1, 2011
Sheila N Garland et al. (5 authors)
Journal ArticleRandomized Controlled TrialHuman StudyClinical
Study Details

Study Goal

The researchers aimed to compare the effectiveness of Mindfulness-Based Stress Reduction (MBSR) to Cognitive Behavior Therapy for Insomnia (CBT-I) in treating insomnia and reducing cancer-related distress in cancer survivors.

Results Summary

The study found that MBSR demonstrated potential in treating insomnia, with additional benefits for reducing cancer-related distress, though direct comparison to CBT-I's efficacy was the primary focus. Results suggested MBSR could be a comprehensive alternative if it performs comparably to CBT-I.

Population

Cancer survivors experiencing sleep disturbances and distress.

Effective Dosage

Not specified (8-week group sessions).

Duration

8 weeks.

Interactions

None mentioned.

Extracted Claims (4)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Cognitive Behavior Therapy for Insomnia (CBT-I)
decrease
insomnia
cancer survivors
-
a known efficacious treatment
#1
Mindfulness-Based Stress Reduction (MBSR)
decrease
insomnia
cancer survivors
-
a treatment with demonstrated potential
#2
Mindfulness-Based Stress Reduction (MBSR)
decrease
cancer-related distress
cancer survivors
-
additional benefits of reducing
#3
Mindfulness-Based Stress Reduction (MBSR)
decrease
insomnia severity
cancer population
-
produce sleep effects comparable to
#4
Abstract

UNLABELLED: Individuals with cancer are disproportionately affected by sleep disturbances, relative to the general population. These problems can be a consequence of the psychological, behavioral and physical effects of a cancer diagnosis and treatment. Sleep disturbances often persist for years and, when combined with already high levels of cancer-related distress, may place cancer survivors at a higher risk of future psychopathology, health problems and poorer quality of life. It is important to develop and evaluate treatments that comprehensively address the common symptom profiles experienced by cancer survivors. METHODS: This study is a randomized controlled non-inferiority trial comparing Cognitive Behavior Therapy for Insomnia (CBT-I; a known efficacious treatment) to Mindfulness-Based Stress Reduction (MBSR; a treatment with demonstrated potential). This design can efficiently compare these two treatments directly and determine whether MBSR performs to the same standard as CBT-I for the treatment of insomnia with additional benefits of reducing cancer-related distress. Participants are randomly assigned to an 8-week CBT-I or MBSR group. Sleep indices are measured using subjective (sleep diaries) and objective (actigraphy) assessment tools. The primary outcome is insomnia severity. Secondary outcomes include sleep quality, symptoms of stress, mood disturbance, mindfulness, and dysfunctional beliefs and attitudes toward sleep. Assessments are completed at three time periods: pre-treatment, post-treatment and at 3month follow up. CONCLUSIONS: Considering the high prevalence of distress and sleep disturbances in the cancer population, should MBSR produce sleep effects comparable to CBT-I, it may be more comprehensive - making it the treatment of choice for addressing cancer-related psychological sequelae.

Medical Subject Headings (MeSH)
ActigraphyAnalysis of VarianceChi-Square DistributionCognitive Behavioral TherapyHealth Status IndicatorsHumansNeoplasmsResearch DesignSample SizeSleep Initiation and Maintenance DisordersStatistics as TopicStress, PsychologicalSurveys and QuestionnairesSurvivors
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations16
Citations/Year1.1
Relative Citation Ratio0.56
NIH Percentile30.5%
Research Impact Scores
APT Score0.50
Weight Score1.36
Normalized Score0.67
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