Brief CBT for Anxiety and Advanced Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Anxiety symptoms as measured by the Hamilton Anxiety Rating Scale
研究概览
简要总结
RATIONALE: Providing cognitive-behavioral therapy (CBT) may reduce anxiety and improve quality of life of patients with advanced cancer.
PURPOSE: To examine the development and pilot testing of a brief cognitive-behavioral therapy intervention to treat anxiety and improve quality of life in patients with advanced cancer.
Hypothesis: Patients with anxiety associated with advanced cancer who receive CBT will report significantly fewer anxiety symptoms compared to those in the comparison condition.
详细描述
OBJECTIVES:
- To develop and examine the feasibility and patient acceptability of administering a manualized cognitive-behavioral intervention that improves quality of life by treating anxiety in patients with advanced cancer.
- To estimate the effect size of a manualized cognitive-behavioral intervention to reduce anxiety in patients with advanced cancer.
- To estimate the effect size for the secondary outcomes (i.e., depression and quality of life) and to examine the extent to which specific variables (i.e., sex, age, chemotherapy side effects, pain levels) are consistent with the conceptual model as potential moderators of treatment effect.
OUTLINE: This is a pilot study followed by a randomized study. Patients are stratified according to type of cancer.
- Pilot study: Patients complete qualitative interviews to explore ways that anxiety impacts patients, to identify components of a cognitive-behavioral therapy intervention that are most useful, and to determine the optimal method of delivery for the intervention (e.g., number and timing of interventions, administration during chemotherapy infusions when feasible). Based upon these results a full treatment manual is written for use in the randomized study.
Patients are then randomized to 1 of 2 treatment arms.
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)
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
- •Diagnosis of incurable solid tumor cancers
- •At least four weeks post-diagnosis
- •Current symptoms of anxiety and anxiety as principal psychiatric problem
- •Patients with co-morbid depression are eligible as long as anxiety symptoms are primary
- •Concurrent pharmacotherapy for anxiety allowed
排除标准
- •Delirium or dementia
- •Active and untreated major psychiatric condition such as schizophrenia or bipolar disorder, other psychotic disorders, or substance dependence
- •Other inability to complete informed consent process or study procedures
研究组 & 干预措施
Intervention - CBT
Participants randomized to the intervention group received cognitive behavioral therapy (CBT) for anxiety after completing a baseline assessment consisting of clinician administered psychiatric evaluations and a psychosocial self-report battery. After completing the CBT intervention, consisting of 6-7 sessions over the course of 2-3 months, participants completed a post-intervention assessment identical to the baseline.
干预措施: Brief Cognitive Behavioral Therapy (Behavioral)
Routine Care Control
Participants randomized to the control condition completed a baseline assessment consisting of clinician administered psychiatric evaluations and a psychosocial self-report battery. They then received routine medical care. After 2 months and after completing the post clinical assessment identical to the baseline, they were offered the opportunity to receive the CBT intervention for free. This ensured that all participants ultimately received cognitive-behavioral therapy if desired, while permitting an examination of the effect size for the intervention compared to routine care.
结局指标
主要结局
Anxiety symptoms as measured by the Hamilton Anxiety Rating Scale
时间窗: 1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment)
The Hamilton Anxiety Ratings Scale (HAM-A) consists of 14 items that provide an overall measure of global anxiety.
次要结局
- Depression as measured by the Montgomery Asberg Depression Rating Scale(1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment))
- Quality of life as measured by the Functional Assessment of Scale Cancer Therapy (FACT-G)(1) At enrollment pre-intervention. 2) Post intervention (2-3 months after enrollment))
研究者
Joseph A. Greer, Ph.D.
Clinical Assistant in Psychology
Massachusetts General Hospital