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

University of Calgary111 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

111

Conditions

Cancer Insomnia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Insomnia Severity from baseline to 3 months

Time frame: Baseline, Post-Treatment, 3 month follow up

Secondary Outcomes

Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months

Time frame: Baseline, Post Treatment, 3 month follow up

Change in subjective measures of sleep using Sleep Diaries from baseline to 3 months

Time frame: 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

Time frame: Baseline, Post Treatment, 3 month follow up

Change in Dysfunctional Attitudes and Beliefs about Sleep Scale scores from baseline to 3 months

Time frame: Baseline, Post Treatment, 3 month folllow up

Change in Calgary Symptoms of Stress Inventory scores from baseline to 3 months

Time frame: Baseline, Post Treatment, 3 month folllow up

Change in Five Facet Mindfulness Questionnaire scores from baseline to 3 months

Time frame: Baseline, Post Treatment, 3 month folllow up

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes