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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01335776

Acronym

I-CAN SLEEP

Enrollment

111

Registered

2011-04-14

Start date

2008-09-30

Completion date

2012-07-31

Last updated

2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Insomnia

Keywords

Mindfulness-Based Stress Reduction, Cognitive Behavior Therapy, Actigraphy, Noninferiority, MBSR, CBT-I

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.

Interventions

BEHAVIORALMindfulness-Based Stress Reduction

This intervention is provided over the course of eight, weekly, 90 minute sessions, plus one 6 hour silent retreat.

BEHAVIORALCognitive Behavior Therapy

This treatment is delivered to small groups over the course of 8 weekly, 90 minute sessions

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 objective measures of sleep using Wrist Actigraphy from baseline to 3 months	Baseline, Post Treatment, 3 month follow 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
Change in Dysfunctional Attitudes and Beliefs about Sleep Scale scores from baseline to 3 months	Baseline, Post Treatment, 3 month folllow up

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026