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

Not Applicable

Completed

• Conditions: Cancer; Insomnia
• Interventions: Behavioral: Cognitive Behavior Therapy; Behavioral: Mindfulness-Based Stress Reduction

• Registration Number: NCT01335776
• Lead Sponsor: University of Calgary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2011-04-12
• Study First Submitted QC: 2011-04-13
• Study First Posted: 2011-04-14
• Primary Completion: 2011-07
• Study Completion: 2012-07
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavior Therapy	Cognitive Behavior Therapy	Cognitive Behavior Therapy for insomnia consists of stimulus control therapy, sleep restriction therapy, cognitive therapy and relaxation.
Mindfulness-Based Stress Reduction	Mindfulness-Based Stress Reduction	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.

Primary Outcome Measures

Name	Time	Method
Change in Insomnia Severity from baseline to 3 months	Baseline, Post-Treatment, 3 month follow up

Secondary Outcome Measures

Name	Time	Method
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 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 Five Facet Mindfulness Questionnaire scores from baseline to 3 months	Baseline, Post Treatment, 3 month folllow up
Change in Pittsburgh Sleep Quality Index scores from baseline to 3 months	Baseline, Post Treatment, 3 month follow up

Trial Locations

Locations (1)

Tom Baker Cancer Centre-Holy Cross Site; 🇨🇦 Calgary, Alberta, Canada