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

University of Calgary

Status: Completed

Conditions: Insomnia; Cancer

Treatments: Behavioral: Mindfulness-Based Stress Reduction; Behavioral: Cognitive Behavior Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01335776

RT735639

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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111 participants in 2 patient groups

Cognitive Behavior Therapy

Experimental group

Description:

Cognitive Behavior Therapy for insomnia consists of stimulus control therapy, sleep restriction therapy, cognitive therapy and relaxation.

Treatment:

Behavioral: Cognitive Behavior Therapy

Mindfulness-Based Stress Reduction

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-Based Stress Reduction