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临床试验/NCT04114227
NCT04114227已完成不适用

Acceptance and Commitment Therapy vs. Supportive Psychotherapy With Cystic Fibrosis Patients

Thomas Jefferson University2 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
146
试验地点
2
主要终点
Beck Anxiety Inventory (BAI)

研究概览

简要总结

The objective of the study is to assess the utility of "Acceptance and Commitment Therapy" (ACT) in which subjects learn new ways to manage uncomfortable experiences and feelings and to engage in positive behaviors, over "Supportive Psychotherapy" in which subjects talk about their experiences to date in a cohort of adult Cystic Fibrosis patients. The hypothesis is that six telehealth/webcam sessions of ACT will lead to an improvement in medication and visit compliance, as well as an overall improved sense of well-being and coping skills, particularly as compared with 6 telehealth/webcam sessions of supportive psychotherapy.

详细描述

Patients will be consented in the adult cystic fibrosis clinic at Drexel University, Children's Hospital of Philadelphia, University of Pennsylvania Medical Center, St. Christopher's Hospital for Children, Duke University Medical Center, Augusta University and the University of Pittsburgh. For Philadelphia sites (CHOP, Drexel, UPenn, St. Chris), Chelsi Nurse will consent patients to treatment. If at remote sites (Duke Univ Med Center, Augusta Univ, U Pittsburgh) by our local site appointed representatives will consent patients to the study. All CF patients will be approached to assess interest.

If patients are willing to be in the study, they will be given a packet of screening questionnaires (addendum #1). These questionnaires will ask patients: 1) how often participants experience different thoughts and feelings, including some related to having cystic fibrosis; 2) how often participants take their cystic fibrosis medications; 3) their coping style, including how long participants persist in thinking about something that has happened to them; The subject will complete each questionnaire again after 6 appointments (i.e., about 6 weeks later), and again about 3-months after their sixth appointment.

Finally, the investigators hope to learn whether these therapies affect how often subjects take their cystic fibrosis medications, and how this affects their health and wellbeing.

To study this, the investigators will review the number of appointments that are missed six months before enrolling in the program, and six months after completing therapy.The investigators will also review their pulmonary function tests, whether subjects go to the hospital or see their doctor for any extra visits, and the presence of any ongoing symptoms of depression or anxiety. All data will be taken from Allscripts, the Drexel outpatient medical chart. Data will be taken only from the departments of the pi and co-pi's. At UPenn, the social worker at the site will input data into Drexel Redcap through a link sent to them.

Participants will complete 6 sessions of our ACT with CF manualized intervention. Participants will be asked to complete a series of brief questionnaires at the time of consent. If desired, they can take these homes to complete and mail back.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • Men and women aged 18 and above.
  • Able to read/understand English.
  • Diagnosis of cystic fibrosis.
  • PHQ-9 score > 4 or GAD-7 score > 4.

排除标准

  • History of suicidal attempts or acute suicidal ideation on clinical assessment.
  • Presence of psychotic disorder or symptoms.
  • Pregnant women.
  • Presence of psychiatric disorders that interfere with the participation of the study, judged by the study or treating clinician. Presence of other medical conditions that interfere with participation in the study, judged by the study or treating clinician.

结局指标

主要结局

Beck Anxiety Inventory (BAI)

时间窗: Change at baseline (study entry point, before any sessions have been delivered), after 6 weeks of treatment, 3 months after the end of 6 sessions of treatment.

This scale is a self-report measure of anxiety.

Beck Depression Inventory-II (BDI-II)

时间窗: Change at baseline (study entry point, before any sessions have been delivered), after 6 weeks of treatment, 3 months after the end of 6 sessions of treatment.

Widely used indicator of the severity of depression.

Cognitive Fusion Questionnaire (CFQ13)

时间窗: Beginning of study, after 6 weeks, after 3 months.

Change in cognitive fusion (rigid attachment to one's thoughts as Truth) measures.

Acceptance and Action Questionnaire (AAQ-II)

时间窗: Beginning of study, after 6 weeks, after 3 months.

Change in acceptance measures.

次要结局

  • FEV1/ FVC ratio(3 months before study, 3 months after study.)
  • The Treatment Adherence Questionnaire-CF(Beginning of study, after 6 weeks, after 3 months.)
  • The Cystic Fibrosis Questionnaire-Revised (CFQ-R)(Beginning of study, after 6 weeks, after 3 months.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

C. Virginia O'Hayer

Principal Investigator

Thomas Jefferson University

研究点 (2)

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