Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Change in depression as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
研究概览
简要总结
Using a Hybrid Type 1 Effectiveness-Implementation randomized control trial (RCT) design, the investigators will test the effectiveness of a bundled behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing oncologic surgery (compared with usual care), while examining implementation outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Study staff responsible for administering ratings throughout the study are blinded. This blinding is kept throughout the study until data collection is complete. At the end of the follow-up, the study coordinator will complete a blinding question to try to guess the arm to which each participant was allocated. This will allow to determine whether the blinding procedures in the study were effective.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-screening:
- •To be considered for participation, patients will be screened using PHQ-4 questionnaire. Scores >3 will indicate positive pre-screen (i.e. can be considered for participation and formal screening). Scores < 3 will indicate negative screen (i.e. patient not considered for formal screening due to low risk for anxiety or depression).
- •Adults age ≥60 years
- •Scheduled major thoracic, breast, or abdominal surgery for suspected or confirmed malignancy
- •PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) ≥10 indicating clinically significant depression or anxiety symptoms.
排除标准
- •Barrier to communication (Unable to read, speak, and understand English)
- •Severe cognitive impairment screened by the SBT (Short Blessed Test) >10
- •Acutely suicidal
- •Considered ineligible per the discretion of the oncologic surgeon or study PI
- •Previous participation in this study or another CPMH study of the intervention bundle or its feasibility.
结局指标
主要结局
Change in depression as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
时间窗: Baseline, 1-month follow-up, and 3-month follow-up
* 9 item questionnaire with answers ranging from 0=not at all to 3=nearly every day. * Scores represent: 0-5=mild, 6-10=moderate, 11-15=moderately severe, and 16-20=severe depression.
Change in anxiety as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)
时间窗: Baseline, 1-month follow-up, and 3-month follow-up
* 7 item questionnaire with answers ranging from 0=not at all to 3=nearly every day. Total score for the seven items ranges from 0 to 21. * Scores 0-5=mild anxiety, 6-10=moderate anxiety, 11-15=moderately severe anxiety, and 15-21=severe anxiety.
次要结局
未报告次要终点