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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


N/A
18 Years
N/A
Not Enrolling
Both
Cancer, Insomnia

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Change in Insomnia Severity from baseline to 3 months

Outcome Time Frame:

Baseline, Post-Treatment, 3 month follow up

Safety Issue:

No

Principal Investigator

Tavis S Campbell, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Calgary

Authority:

Canada: Canadian Institutes of Health Research

Study ID:

RT735639

NCT ID:

NCT01335776

Start Date:

September 2008

Completion Date:

July 2012

Related Keywords:

  • Cancer
  • Insomnia
  • Mindfulness-Based Stress Reduction
  • Cognitive Behavior Therapy
  • Actigraphy
  • Noninferiority
  • MBSR
  • CBT-I
  • Sleep Initiation and Maintenance Disorders

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