跳至主要内容
临床试验/NCT06645782
NCT06645782已完成不适用

Virtual, Group Adaptation of a Cystic Fibrosis (CF) Specific Cognitive Behavioural Therapy for Adults With CF: An Exploration of Effectiveness, Feasibility, and Participant Experiences.

University of Regina2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Acceptability of virtual group CF-CBT.

研究概览

简要总结

The overall goal of this clinical trial is to: a) explore the feasibility, acceptability, and participant experiences with the group version of CF-CBT; b) examine the effectiveness of the virtual delivery of a group version of CF-CBT in reducing depression and anxiety symptoms, perceived stress, coping skills, and health related quality of life among adults with CF.

The primary research questions is:

• How feasible and acceptable (i.e., drop out, adherence, and satisfaction) is virtual, group CF-CBT?

The secondary research questions is:

• How will virtual, group CF-CBT affect depression and anxiety?

The tertiary/other research questions are:

  • How will virtual, group CF-CBT affect perceived stress, coping skills, and health related quality of life?
  • What is the association between group cohesion and depression, anxiety, perceived stress, coping skills, and health related quality of life?

Participants will:

  • Complete short demographic questionnaire regarding their personal and health information.
  • Complete questionnaires about symptoms of depression, anxiety, perceived stress, coping skills, and health related quality of life at pre- and post-program. An additional measure of treatment expectancy will be completed at pre-program only. At post-program only, measures of group cohesion and treatment satisfaction will be completed.
  • Complete the CF-CBT online mental health program over eight weeks.
  • Be invited to complete an interview about their experiences with the program.

Primary outcomes will be compared to benchmark study of individual CF-CBT. Secondary outcomes (i.e., depression, anxiety) will be compared against themselves (i.e., pre- and post-group). Tertiary/other outcomes (i.e., perceived stress, coping skills, health related quality of life) will be compared against themselves (i.e., pre- and post-group). The associations between self-reported outcome measures and group cohesion will be analyzed by computing Pearson correlation coefficients.

详细描述

BACKGROUND: CF is a genetic, life-limiting, chronic disease that affects approximately 4300 Canadians (~70,000 to 100,000 patients worldwide; Cystic Fibrosis Canada, 2018; Cystic Fibrosis Worldwide, n.d.; Sawicki et al., 2011). People with cystic fibrosis (pwCF) demonstrate high rates of depression and anxiety (Quittner et al., 2014) and the corresponding deleterious impact on functioning is alarming (e.g., decreased lung function and worse adherence to critical life prolonging therapies; Smith et al., 2010; Yohannes et al., 2012). While evidence-based psychological approaches for depression and anxiety, such as cognitive behavioral therapy (CBT), are effective in reducing depression and anxiety symptoms that are co-morbid with other chronic illnesses (e.g., diabetes, COPD, and cancer; Uchendu & Blake, 2016; Williams et al., 2020; Shi et al., 2019; Gandy et al., 2013; López-López et al., 2019), there is a need to design tailored treatments to address the specialized needs of pwCF. To this end, Friedman, Georgiopoulos, and colleagues developed CF-CBT, an innovative, effective, 8-session, individually delivered CF-specific CBT-based intervention program to promote emotional well-being for adults with CF (Friedman et al., 2022a; Friedman et al., 2022b). Virtual delivery of CF-CBT in a group format is one way to address the potentially prohibitive costs of mental health treatment while also addressing infection control guidelines for pwCF, which preclude in-person groups (Saiman et al., 2014)). CF-CBT has been recently modified (i.e., session structure, activities) for group delivery; however, feasibility, acceptability, effectiveness of, and patient experiences with this mode of delivery have yet to be investigated.

PARTICIPANTS: G*Power 3.1 was used to calculate the study sample size based upon on secondary analyses (i.e., t-test). Assuming 80% power, an alpha of 0.05, and an effect size of 0.5 (medium), a sample size of at least 27 participants would be needed. The investigation aims to recruit 28-30 participants to address attrition. Participants with CF will be recruited from CF clinics in British Columbia, Canada. Participants will be consecutively enrolled into groups upon completing pre-program measures. The investigators will seek to have a 2:1 women to men ratio to address gender variations in mental health symptoms and disorders.

HYPOTHESES:

Primary hypothesis:

  1. Virtual, group CF-CBT will be feasible and acceptable, as indexed by low rates of drop out and high rates of adherence and satisfaction.

研究设计

研究类型
Interventional
分配方式
Na
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

入选标准

  • At least 18 years of age.
  • Must speak and read in English.
  • Must have depression and/or anxiety scores in the mild to moderate range (as per the PHQ-9 and GAD-7) prior to study baseline.

排除标准

  • Those with suicidal intent (either with or without a plan).

研究组 & 干预措施

Virtual, group CF-CBT

Experimental

干预措施: Virtual, Group CF-CBT (Behavioral)

结局指标

主要结局

Acceptability of virtual group CF-CBT.

时间窗: From recruitment to completion of treatment (8 weeks).

Determined by rates of program completion and program satisfaction.

Feasibility of virtual, group CF-CBT.

时间窗: From recruitment to completion of treatment (8 weeks).

Determined by rates of participants recruitment (i.e., how many are interested, enroll) and rates of attendance.

Participant scores on the Client Satisfaction Questionnaire (CSQ) at the end of 8 week treatment.

时间窗: Post-intervention (8 weeks)

The CSQ measures satisfaction with a received service on an 8-item scale with items reflecting how satisfied the individual was with the service they completed. Total scores can range from a minimum score of 8 to a maximum score of 32.

次要结局

  • Change from baseline in the Patient Health Questionnaire-9 (PHQ-9) at the end of 8 week treatment.(Baseline and post-intervention (8 weeks))
  • Change from baseline in the Generalized Anxiety Disorder-7 (GAD-7) at the end of 8 week treatment.(Baseline and post-intervention (8 weeks))

研究者

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

Anna Dollimount

Principal Investigator

University of Regina

研究点 (2)

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