Transforming Psychotherapy for Chronically Ill Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- State-trait Anxiety Inventory (STAI), a 40-item self-report measure of anxiety symptoms.Beck Depression Inventory-II (BDI-II), assessing 21 depression symptoms. Client Satisfaction Questionnaire (CSQ), an 8-item, empirical, self-report measure.
研究概览
简要总结
The primary objective of this research is to pilot test a brief mental heath treatment specifically tailored to meet the needs of chronically ill patients with anxiety and/or depression. Using an open-trial format, the proposed study will examine the feasibility of a brief psychosocial intervention. Primary outcomes will assess intervention effects on patient and clinician rated symptoms of anxiety and depression. If proven feasible and effective among this group of participants, the intervention (due to its brief format and focus on medically ill patient needs) will possess unique characteristics that will increase the ability of medical care settings to implement mental health treatments, and will provide valuable pilot data for the development of a larger research project to determine the efficacy of this intervention among a larger group of chronically ill patients relative to usual care.
详细描述
Select one category that most adequately describes your research:
Pilot
Discuss the research design including but not limited to such issues as: probability of group assignment, potential for subject to be randomized to placebo group, use of control subjects, etc.
The proposed project is designed to pilot test the feasibility of a brief psychosocial intervention among depressed and/or anxious medical patients with confirmed symptoms of COPD and/or CHF causing significant impairment as ascertained by validated surveys. We will test the intervention with an open-trial format. Therefore, all patients who meet the inclusion criteria described below will receive the intervention. Group assignment, randomization, and use of control subjects are not applicable to this pilot research project. Data will be collected at baseline, post-treatment (8 weeks), and at 3 month follow-up. Trained members of the study staff will conduct assessments, intervention and follow-up sessions following a protocol. A licensed psychologist will supervise all members of the study staff.
F2. Procedure
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
- 是
入选标准
- •Confirmation of CHF or COPD diagnosis according to medical chart review
- •Ongoing symptoms of functional limitations due to CHF (NYHA classification of II , III, or IV as obtained by telephone interview) or COPD (Score of 3 or greater on the Medical Research Council Dyspnoea Scale [MRC] as obtained by telephone interview)
- •Eligible patients must have clinically significant symptoms of either anxiety and/or depression as measured using patient self report questionnaires. Clinical cutoff scores for depression will be based on the Beck Depression Inventory - Second Edition (scores of 14 or more) while anxiety cutoffs will be determined using the State-Trait Anxiety Inventory (score of 40 or greater)
- •Eligible patients will be English-speaking, as this intervention has not yet been translated to any other language.
排除标准
- •History of substance abuse, bipolar disorder, psychosis or active suicidal intent (obtained from chart review and standardized structured clinical interview)
- •NYHA class I, or MRC levels 1 and
- •Class 1 CHF patients and Level 1 and 2 COPD patients (by definition) will have no significantly limiting CHF or COPD symptoms. This information will be obtained through patient self-report of CHF and COPD symptoms
- •Mental status examination score in the cognitively impaired range on an established 6-item screen
- •Inability to provide informed consent or severe physical limitations restricting completion of the study protocol (e.g. vision, hearing, or physical functioning)
- •Non-English speaking patients will be excluded from participation, as this intervention has not yet been translated to any other language.
结局指标
主要结局
State-trait Anxiety Inventory (STAI), a 40-item self-report measure of anxiety symptoms.Beck Depression Inventory-II (BDI-II), assessing 21 depression symptoms. Client Satisfaction Questionnaire (CSQ), an 8-item, empirical, self-report measure.
时间窗: Assessments at baseline, post treatment, and 3 month follow-up.
次要结局
- Kansas City Cardiomyopathy Questionnaire (KCCQ), a 23-item self-report measure of constructs. Chronic Respiratory Questionnaire (CRQ), measuring QoL change over time in COPD patients. Short Form 36 (SF-36), a generic measure of health-related QoL.(Assessments at baseline, post treatment, and 3 month follow-up.)