UNIVERSITY OF CALGARY controlled, non-inferiority trial investigating mindfulness-based and cognitive-behavioral

UNIVERSITY OF CALGARY
Non-pharmacological treatment of insomnia in cancer patients: A randomized,
controlled, non-inferiority trial investigating mindfulness-based and cognitive-behavioral
approaches
by
Sheila Nadine Garland
A DISSERTATION
SUBMITTED TO THE FACULTY OF GRADUATE STUDIES
IN PARTIAL FULFILMENT OF THE REQUIREMENTS FOR THE
DEGREE OF DOCTOR OF PHILOSOPHY
DEPARTMENT OF PSYCHOLOGY
CALGARY, ALBERTA
AUGUST, 2012
© Sheila Nadine Garland 2012
Abstract
Patients who are diagnosed and treated for cancer are three times more likely than
the general population to experience disturbed sleep and insomnia. The presence of
persistent insomnia places patients at a higher risk for psychological and physical
morbidity and reduced quality of life. This dissertation examined the use of non-
pharmacological interventions to address insomnia in a heterogeneous sample of cancer
patients. Cognitive-Behavioral Therapy for insomnia (CBT-I) is considered a well-
established intervention, however a substantial proportion of people do not experience a
treatment response or complete insomnia remittance. Mindfulness-Based Stress
Reduction (MBSR) is generating a considerable amount of research interest in the area of
insomnia due to its demonstrated effectiveness in reducing cognitive and physiological
arousal, factors associated with disturbed sleep. We employed a non-inferiority design to
determine whether MBSR performs to the same standard as CBT-I for insomnia, while
providing additional benefits such as improved mood and lower appraisals of stress.
MBSR was non-inferior to CBT-I for improving sleep when assessed three months after
treatment completion, but not immediately post-program. This result is attributed to
MBSR producing slower but continual improvements over time while CBT-I generated
rapid effects that were largely maintained. While both groups demonstrated the ability to
reduce stress symptoms and mood disturbance, those receiving CBT-I uniquely improved
sleep quality and dysfunctional sleep beliefs. Secondary analyses were performed on the
full sample (N=111) to examine associations between dispositional mindfulness, sleep
and psychological outcomes. Mindfulness facets of acting with awareness, non-judging
and non-reacting were associated with better sleep and psychological outcomes, but
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mindfulness was not predictive of fewer sleep disturbances above and beyond the
influence of symptoms of stress and mood disturbance. We then focused specifically on
the MBSR group (n=32) to examine whether improvements in mindfulness were
associated with sleep and psychological outcomes. This sub-study suggests that one of
the mechanisms by which MBSR may improve sleep outcomes is through a reduction in
dysfunctional sleep-related beliefs. This body of work emphasizes the need to conduct
patient-centered research and expands potential treatment options for patients with
insomnia.
Preface
In the course of this dissertation, the following four manuscripts have been
prepared for publication, the first of which has been published. In all cases, the first
author undertook the analysis, interpreted the results, and wrote the manuscripts. This
was completed under the guidance of Drs. Carlson and Campbell. All authors provided
critical reviews of the manuscripts and contributed intellectual content. The published
article was reproduced in its entirety and included as a chapter in this document with
permission from the publisher.
Garland, S. N., Carlson, L. E., Antle, M., Samuels, C., & Campbell, T. (2011). I-
CAN SLEEP: Rationale and Design of a non-inferiority RCT of Mindfulness-Based
Stress Reduction (MBSR) and Cognitive Behavioral Therapy (CBT) for the treatment of
Insomnia in CANcer survivors. Contemporary Clinical Trials, 32(5), 747-754
Garland, S. N., Carlson, L. E., Antle, M., Samuels, C., & Campbell, T. A
Comparison of Mindfulness-Based Stress Reduction to Cognitive Behavioral Therapy for
the Treatment of Insomnia Comorbid with Cancer: a Randomized, Non Inferiority Trial.
Garland, S. N., Campbell, T. S., & Carlson, L.E. Associations between
Dispositional Mindfulness, Insomnia, Sleep Quality and Dysfunctional Sleep Beliefs in
Post-Treatment Cancer Patients.
Garland, S. N., Campbell, T. S., & Carlson, L.E. Impact of Mindfulness-Based
Stress Reduction on Mindfulness and Dysfunctional Sleep Beliefs in Cancer Patients with
Insomnia.
Acknowledgements
As I reflect on the people who have played key roles in helping me get to where I
am today, I must begin by recognizing the important contribution of Dr. Linda Carlson. I
am not sure why she chose me to be her undergraduate honours student, but that decision
changed the direction of my life. Linda has been an incredibly positive role model. She
has demonstrated that success only comes when you have passion, determination, and
resilience. Linda has always encouraged me to set high standards and work hard to
achieve them. I have learned many lessons from Linda, some of them difficult, but all of
them necessary. Linda has provided me with a very solid foundation from which to build
my career and I am forever grateful.
I have also been extremely fortunate to have the guidance of Dr. Tavis Campbell,
who has provided formal and informal supervision throughout my graduate training.
Tavis has helped me refine the skills required to develop a professional identity and
negotiate complex relationships within academia and research. I appreciate that he has
always been available in times of trial, transition and celebration. I am now proud to call
Tavis a friend and colleague.
To my committee members, Dr. Mike Antle, Dr. Valerie Kirk and Dr. Cynthia
Gross, I appreciate the time and expertise you have volunteered to review this
dissertation. I hope you have as much fun reading about this project as I have had in
conducting it.
I am fortunate to have had the opportunity to train in a department that is
internationally recognized for its research and clinical excellence. I would like to
acknowledge the many other staff and students whom I have had the pleasure to work
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