Acceptance and Commitment Therapy for Infertility Patients: A Case Series
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Acceptability of the Intervention
研究概览
简要总结
In the United States, around 19% of reproductive-aged couples suffer from infertility. The psychological distress associated with infertility is well-established; those diagnosed commonly experience depression and anxiety symptoms, diminished quality of life, and relationship dissatisfaction. In the current study, the investigators report on a case series, in which up to 10 infertility patients will receive 12 sessions of Acceptance and Commitment Therapy (ACT). The overarching goal for the current case series is to determine whether ACT might be well-suited for infertility patients experiencing distress. The specific aims are: 1) to describe the components of the intervention that was delivered; 2) to determine the extent to which infertility patients perceive a 12-session ACT intervention beneficial and acceptable; 3) to describe change in mood, stress, and ACT processes across 12 sessions of ACT; and 4) to highlight potential processes through which ACT might promote benefits to the patient by describing how change in mood, stress, and ACT processes relate to each other over the course of 12 sessions of ACT.
详细描述
In this study, the investigators present Acceptance and Commitment Therapy (ACT) as a potentially well-suited intervention for infertility patients, and they highlight mechanisms and processes through which ACT might benefit patients. They present a series of cases in which the therapist uses an ACT approach to treat individuals diagnosed with infertility.
The Duke University Health System includes a fertility clinic, which houses an embedded clinical psychology team. Patients at the fertility center can participate in individual psychotherapy and/ or group psychotherapy as part of their fertility treatment. An interventionist will provide psychotherapy to up to 10 individuals on the therapy waitlist. Patients will be eligible for the study if they: are at least 18 years old, have a diagnosis of infertility, speak English, and are not already participating in individual therapy. Patients will be excluded from the study if they endorse current suicidality and/ or self-harming behavior, current psychosis symptoms, and/ or current substance use.
For those that enroll in the study, patients will complete 12 therapy sessions in the fertility clinic, with sessions lasting between 50 and 60 minutes. Although sessions will vary across individuals, the therapist will aim to target the six core ACT processes in all cases. The therapist will offer both in-person and virtual sessions. Participants will complete a subset of questionnaires at each study session.
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
- 否
入选标准
- •Patients will be eligible if they
- •are at least 18 years old
- •have a diagnosis of infertility
- •speak English
- •are not already participating in individual therapy.
排除标准
- •Patients will be excluded from the study if they
- •endorse current suicidality and/ or self-harming behavior
- •current psychosis symptoms
- •and/ or current substance use
结局指标
主要结局
Acceptability of the Intervention
时间窗: Week 6 (Session 6) and week 12 (Session 12).
Patients will answer several questions about the extent to which they perceive the intervention to be beneficial and acceptable. Patients will answer questions using a 5-point Likert scale, with 1 being 'strongly disagree' and 5 being 'strongly agree.' The investigators will use this information descriptively--for each question, they will describe patient responses by identifying the percentage of patients that responded with each option (e.g., 7 out of 10 patients indicated that they strongly agreed with the following question: \[question\]).
次要结局
- Change in Modified Differential Emotions Scale (mDES)(Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).)
- Change in Valuing Questionnaire (VQ)(Week 1 (Session 1), week 3 (Session 3), week 6 (Session 6), week 9 (Session 9), and week 12 (Session 12).)
- Change in Values-Based Behavior(All sessions, weeks 1-12.)
- Change in Patient Health Questionnaire 9 (PHQ-9)(PHQ-9: Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).)
- Change in Generalized Anxiety Disorder Questionnaire 2 (GAD-2)(GAD-2: Weeks 2 (Session 2), 3 (Session 3), 4 (Session 4), 5 (Session 5), 7 (Session 7), 8 (Session 8), 9 (Session 9), 10 (Session 10), and 11 (Session 11).)
- Change in Intolerance of Uncertainty (IUS)(Week 1 (Session 1), week 3 (Session 3), week 6 (Session 6), week 9 (Session 9), and week 12 (Session 12).)
- Change in Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT-15)(Week 1 (Session 1), week 3 (Session 3), week 6 (Session 6), week 9 (Session 9), and week 12 (Session 12).)
- Change in Fertility Problem Inventory (FPI)(Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).)
- Change in Patient Health Questionnaire 2 (PHQ-2)(PHQ-2: Weeks 2 (Session 2), 3 (Session 3), 4 (Session 4), 5 (Session 5), 7 (Session 7), 8 (Session 8), 9 (Session 9), 10 (Session 10), and 11 (Session 11).)
- Change in Generalized Anxiety Disorder Questionnaire 7 (GAD-7)(GAD-7: Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).)