A Comparison of MBSR and CBT for the Treatment of Insomnia in Cancer (I-CAN SLEEP)

This study has been completed.
Sponsor:
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
Tavis S. Campbell, University of Calgary
ClinicalTrials.gov Identifier:
NCT01335776
First received: April 12, 2011
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Cancer
Insomnia
Behavioral: Mindfulness-Based Stress Reduction
Behavioral: Cognitive Behavior Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Change in Insomnia Severity from baseline to 3 months [ Time Frame: Baseline, Post-Treatment, 3 month follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months [ Time Frame: Baseline, Post Treatment, 3 month follow up ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Change in Pittsburgh Sleep Quality Index scores from baseline to 3 months [ Time Frame: Baseline, Post Treatment, 3 month follow up ] [ Designated as safety issue: No ]
  • Change in Dysfunctional Attitudes and Beliefs about Sleep Scale scores from baseline to 3 months [ Time Frame: Baseline, Post Treatment, 3 month folllow up ] [ Designated as safety issue: No ]
  • Change in Calgary Symptoms of Stress Inventory scores from baseline to 3 months [ Time Frame: Baseline, Post Treatment, 3 month folllow up ] [ Designated as safety issue: No ]
  • Change in Five Facet Mindfulness Questionnaire scores from baseline to 3 months [ Time Frame: Baseline, Post Treatment, 3 month folllow up ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: September 2008
Study Completion Date: July 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavior Therapy
Cognitive Behavior Therapy for insomnia consists of stimulus control therapy, sleep restriction therapy, cognitive therapy and relaxation.
Behavioral: Cognitive Behavior Therapy
This treatment is delivered to small groups over the course of 8 weekly, 90 minute sessions
Other Name: CBT-I
Experimental: 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.
Behavioral: Mindfulness-Based Stress Reduction
This intervention is provided over the course of eight, weekly, 90 minute sessions, plus one 6 hour silent retreat.
Other Name: MBSR

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335776

Locations
Canada, Alberta
Tom Baker Cancer Centre-Holy Cross Site
Calgary, Alberta, Canada, T2S 3C1
Sponsors and Collaborators
University of Calgary
Canadian Cancer Society Research Institute (CCSRI)
Investigators
Principal Investigator: Tavis S Campbell, PhD University of Calgary
  More Information

No publications provided by University of Calgary

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tavis S. Campbell, Associate Professor of Psychology, University of Calgary
ClinicalTrials.gov Identifier: NCT01335776     History of Changes
Other Study ID Numbers: RT735639
Study First Received: April 12, 2011
Last Updated: June 17, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University of Calgary:
Mindfulness-Based Stress Reduction
Cognitive Behavior Therapy
Actigraphy
Noninferiority
MBSR
CBT-I

ClinicalTrials.gov processed this record on September 18, 2014