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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Cancer Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cognitive Behavior Therapy

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

Group Type EXPERIMENTAL

Cognitive Behavior Therapy

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Mindfulness-Based Stress Reduction

Intervention Type BEHAVIORAL

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

Interventions

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Mindfulness-Based Stress Reduction

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

Intervention Type BEHAVIORAL

Cognitive Behavior Therapy

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

Intervention Type BEHAVIORAL

Other Intervention Names

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MBSR CBT-I

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No