Mindfulness Based Program for Infertility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 主要终点
- Changes in Mindfulness skills assessed by the Five Facet Mindfulness Questionnaire (FFMQ)
研究概览
简要总结
The current study aims to test the efficacy a mindfulness based intervention for women facing fertility problems - the Mindfulness Based Program for Infertility (MBPI). MBPI comprises 10 weekly group sessions of approximately 2 hours each, run in small groups of 10-15 women. The main goal of MBPI intervention is to reduce depressive and anxiety symptoms and promote infertility self-efficacy and acceptance and mindfulness skills. The MBPI is intended to develop willingness/acceptance through a process of contacting the present moment and be in touch with the unfolding experience in an open and non-judgmental way, particularly infertility-related experiences.
详细描述
The Mindfulness Based Program for Infertility (MBPI) was developed based on the Mindfulness Based Program for Stress Reduction, the Mind/Body Program for Infertility and basic principles of Acceptance and Commitment Therapy. This program aims, fundamentally, learning and practicing emotion regulation skills, particularly mindfulness and acceptance. It addresses values (chosen life directions) clarification, interpersonal communication, healthy lifestyles, and emotional self-care. The training of these skills occurs at all sessions and is also encouraged between sessions. Support materials are provided for this, including a Participant's Manual and an audio CD with several mindfulness meditation instructions. The MBPI encloses 10 weekly sessions of 2 hours each, except for one of the sessions that lasts for one day. It is a structured psychosocial intervention program, with a group format (max. 15 women). Male partners are invited to participate in 3 sessions.
MBPI sessions were carried out by a clinical psychologist with previous training in contextual-behavioral therapies. A Therapist Manual was structured, describing the details for conducting each session.
Most of the MBPI sessions follow a similar structure. They begin with a first half-hour of sharing (optional). After the first half hour a formal mindfulness practice is held, followed by sharing how participants felt, what they have noticed, how was the experience for them. The set of formal practices selected for the MBPI is commonly used in mindfulness programs. Informal mindfulness practice is also presented as early as the second session through mindful eating. The three minutes breathing space exercise ends each session. Metaphors and experiential exercises are included in most of the sessions. These comprise an experiential exercise of listening to others, the introduction of values clarification (valued life directions) through the imagery exercise "10 years of marriage", the integration of a greater number of positive aspects in day-to-day experience, a psychoeducational component regarding healthy lifestyle (exercise, nutrition, caffeine, alcohol, nicotine, etc.). Moreover, the promotion of psychological flexibility/acceptance is intended to be achieved through mindfulness practice, but also through the use of metaphors such as "the mind as a radio always on", "the coach and passengers" and through emphasizing the importance of values clarification and committed action.
Previously to data collection, ethical approval was obtained from the Scientific Council of the Faculty of Psychology and Educational Sciences of the University of Coimbra. Participants were women aged 18 years old or older, presenting a medically established infertility diagnosis. Participants answered a recruitment announcement posted at the Portuguese Fertility Association (patients association) website after getting the approval of this association board. Participants were informed about the voluntary and confidential nature of the data. A semi-structured clinical interview was used for MBPI admission. This interview allows the gathering of demographic and clinical data and the screening for severe psychopathology. Women who answered the recruitment announcement but lived in places where the MBPI sessions were not scheduled were invited to participate in the study as members of the control group and were given the opportunity to participate in future editions.
All participants were required to sign the informed consent and a numerical unique code was assigned to each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 48 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women dealing with an infertility diagnosis (independently of female, male, both female and male or unknown factor), pursuing infertility medical treatment
排除标准
- •Severe psychiatric problems assessed through a semi-structured clinical interview used for MBPI admission
研究组 & 干预措施
Mindfulness Based Program for Infertility
Behavioral: MBPI
The Mindfulness Based Program for Infertility is a manualized group psychological intervention derived from contextual or 3rd wave cognitive-behavioral therapies intended to develop mindfulness and acceptance skills, as well as to promote perceptions of self-efficacy to deal with the demands of an infertility diagnosis and medical treatment. It comprises 10 weekly sessions of approximately 2hr each, run in small groups (ranging from 10 to 15 participants).
干预措施: Mindfulness Based Program for Infertility (Behavioral)
Treatment As Usual (TAU)
Standard infertility medical treatment provided by IVF clinics (public and private) - no psychological intervention being pursued.
结局指标
主要结局
Changes in Mindfulness skills assessed by the Five Facet Mindfulness Questionnaire (FFMQ)
时间窗: 7 years and 8 months (from Baseline to 7-years follow-up)
Assessed by the Five Facet Mindfulness Questionnaire (FFMQ)
Changes in depressive symptoms assessed by the Beck Depressive Inventory (BDI)
时间窗: 7 years and 8 months (from Baseline to 7-years follow-up)
Assessed by the Beck Depressive Inventory (BDI)
Changes in perceptions of infertility self-efficacy assessed by the Infertility Self-efficacy Scale (ISE)
时间窗: 7 years and 8 months (from Baseline to 7-years follow-up)
Assessed by the Infertility Self-efficacy Scale (ISE)
次要结局
- Changes in anxiety symptoms assessed by the Spielberger State Anxiety Inventory (STAI-Y1)(7 years and 8 months (from Baseline to 7-years follow-up))
- Changes in acceptance skills assessed by the Acceptance and Action Questionnaire (AAQ-II)(7 years and 8 months (from Baseline to 7-years follow-up))
- Changes in self-compassion assessed by the Self-compassion Scale (SCS)(7 years and 8 months (from Baseline to 7-years follow-up))
研究者
Ana Galhardo
Principal Investigator
University of Coimbra
