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OpenTrials
Completed

NCT Number: NCT01335776

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

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.

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Key information

Conditions

Cancer Dyssomnias Insomnia Mental Disorders Neoplasms Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tom Baker Cancer Centre-Holy Cross Site

Calgary, Alberta, T2S 3C1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Stress Reduction

Behavioral

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

Other names: MBSR

Cognitive Behavior Therapy

Behavioral

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

Other names: CBT-I

Primary outcomes

  1. Change in Insomnia Severity from baseline to 3 months

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

Secondary outcomes

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

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

  2. 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)

  3. Change in Pittsburgh Sleep Quality Index scores from baseline to 3 months

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

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

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Canadian Cancer Society (CCS)

Registry information

Official study title

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

Acronym: I-CAN SLEEP

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Apr 14, 2011
Registry last updated
Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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