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Women with breast cancer who report insomnia that started or worsened during breast cancer diagnosis and treatment will be enrolled in a group behavioral trial to one of two arms testing cognitive behavioral therapy for insomnia against a mindfulness-based therapy.
The investigators are recruiting breast cancer survivors with stage I-III or Eastern Cooperative Oncology Group 0-1 breast cancer to enroll in a group-delivered behavioral trial for insomnia. The investigators are comparing mindfulness-based therapies delivered in an alternative medicine context to cognitive behavioral therapy for insomnia. The intervention is 9 weeks, for two hours weekly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-I | Active Comparator | Cognitive Behavioral Therapy for Insomnia |
|
| Mindfulness | Experimental | Mindfulness-Based Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Therapy | Behavioral | Participants are taught relaxation and mindfulness techniques to practice. They also learn about various alternative medicine modalities to which they can apply mindfulness with the target of reducing insomnia. The group meets weekly for 2 hours for a duration of 9 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insomnia | Measured using the Insomnia Severity Index (Scale 0-28; higher scores are worse, with 15+ indicating clinical insomnia) | Nine weeks |
| Change in Insomnia | Measured using the Pittsburgh Sleep Quality Index (Scale 0-21; higher scores are worse) | Nine weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive function | Measured via the FACT-Cog (Scale 0-132; higher is better) | Nine weeks |
| Change in cognitive function | Measured via the Montreal Cognitive Assessment (MOCA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GW Center for Integrative Medicine | Washington D.C. | District of Columbia | 20052 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| Cognitive Behavioral Therapy for Insomnia | Behavioral | A licensed psychologist is delivering Cognitive Behavioral Therapy for Insomnia to women for 90-120 minutes weekly for nine weeks. The Cognitive Behavioral Therapy for Insomnia protocol is well documented in published literature. |
|
| Nine weeks |
| Change in Fatigue | Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue (Scale 8-40; higher is worse) | Nine weeks |
| Change in Insomnia | Measured using an actigraph | Nine weeks |
| D001523 |
| Mental Disorders |