CBTI-CS: A Novel Cognitive-Behavioral Treatment for Insomnia in Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- The Insomnia Severity Index (ISI)
研究概览
简要总结
This research study is evaluating the effectiveness of a 3-session behavioral intervention for insomnia in cancer survivors. This is a behavioral intervention study, and no medications are involved.
详细描述
This study is being done to test the usefulness of a 3-session cognitive-behavioral intervention for improving insomnia in cancer survivors. In this study, the investigators are testing whether this 3-session intervention (Cognitive Behavior Therapy for Insomnia in Cancer Survivors: CBTI-CS) will improve insomnia in cancer survivors whose continue to have insomnia symptoms after receiving sleep hygiene education.
In addition to the participants who will be offered sleep hygiene education and the 3-session CBTI-CS,10 additional participants will be recruited to participate in a pilot evaluation of the CBTI-CS intervention delivered via telehealth. This will be a pilot aspect of the study and data from these participants will be for descriptive purposes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •History of a cancer diagnosis
- •No active cancer therapy (excluding chemoprevention) in the past year, and no cancer therapy planned in the next 6 months
- •No surgery planned in the next 6 months
- •Significant insomnia as evidenced by an Insomnia Severity Index score ≥12
- •Able to read and write in English
- •Willing to attend study group sessions
- •Motivated and able to follow the demands of the CBTI-CS program, to keep sleep records, complete self-report symptom reports and make changes in their sleep schedule, including restricting their sleep.
排除标准
- •Survivors who report ever being diagnosed with Bipolar Disorder will be excluded.
- •Survivors who report ever being diagnosed with a Seizure Disorder or have experienced a seizure in the past 12 months will be excluded.
- •Intention to adjust (decrease or increase) use of sedative, hypnotic, or over-the-counter medications that can affect sleep during the study period.
- •Have diagnosed, untreated sleep apnea, or sleep apnea suspected by a physician but which has not been evaluated, or other sleep disorder
- •Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel that involves adjusting to different time zones, or employment in a position that could impact public safety (such as operating heavy machinery)
- •Refusal to modify or reduce excessive alcohol use that is likely to interfere with an individual's sleep.
研究组 & 干预措施
Arm A (Sleep Hygiene & CBTI-CS)
Participants receive a single educational session describing principles of Sleep Hygiene for Cancer Survivors. Those who continue to have significant symptoms of insomnia then receive 3 groups CBTI-CS sessions
干预措施: CBTI-CS (Behavioral)
Arm A (Sleep Hygiene & CBTI-CS)
Participants receive a single educational session describing principles of Sleep Hygiene for Cancer Survivors. Those who continue to have significant symptoms of insomnia then receive 3 groups CBTI-CS sessions
干预措施: Sleep Hygiene (Behavioral)
Arm B (Telehealth Pilot of CBTI-CS)
Descriptive data collected on 10 participants (non-randomized) receiving CBTI-CS via Telehealth.
干预措施: CBTI-CS via Telehealth (Behavioral)
结局指标
主要结局
The Insomnia Severity Index (ISI)
时间窗: Change from Baseline to 4-weeks post-intervention
The ISI is a 7-item self-report questionnaire assessing severity, and impact of insomnia symptoms.
次要结局
- Profile of Mood States - Short Form (POMS-SF)(Change from Baseline to 4 & 8 weeks post-intervention)
- The Insomnia Severity Index (ISI)(Change from Baseline to 8 weeks post-intervention)
研究者
Christopher Recklitis, Ph.D
Christopher Recklitis, PhD, MPH
Dana-Farber Cancer Institute