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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cancer, Insomnia

Intervention / Treatment
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* Behavioral: Mindfulness-Based Stress Reduction
* Behavioral: Cognitive Behavior Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavior Therapy<br>Cognitive Behavior Therapy for insomnia consists of stimulus control therapy, sleep restriction therapy, cognitive therapy and relaxation. | Behavioral: Cognitive Behavior Therapy<br>* This treatment is delivered to small groups over the course of 8 weekly, 90 minute sessions<br>* Other names: CBT-I;|
| Experimental: Mindfulness-Based Stress Reduction<br>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<br>* This intervention is provided over the course of eight, weekly, 90 minute sessions, plus one 6 hour silent retreat.<br>* Other names: MBSR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity from baseline to 3 months |  | Baseline, Post-Treatment, 3 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months |  | Baseline, Post Treatment, 3 month follow up | 
| 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) | 
| Change in Pittsburgh Sleep Quality Index scores from baseline to 3 months |  | Baseline, Post Treatment, 3 month follow up | 
| Change in Dysfunctional Attitudes and Beliefs about Sleep Scale scores from baseline to 3 months |  | Baseline, Post Treatment, 3 month folllow up | 
| Change in Calgary Symptoms of Stress Inventory scores from baseline to 3 months |  | Baseline, Post Treatment, 3 month folllow up | 
| Change in Five Facet Mindfulness Questionnaire scores from baseline to 3 months |  | Baseline, Post Treatment, 3 month folllow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness-Based Stress Reduction, Cognitive Behavior Therapy, Actigraphy, Noninferiority, MBSR, CBT-I