HEAL-FHA: Health and Lifestyle Support for Functional Hypothalamic Amenorrhea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of participants with return of spontaneous menstrual bleeding within 9 months
研究概览
简要总结
The goal of this clinical trial is to learn whether a 10-week psychoeducational health and lifestyle intervention can help women with Functional Hypothalamic Amenorrhea (FHA) restore their endocrine balance and menstrual cycles.
The main questions the study aims to answer are:
Does the intervention lead to the return of regular menstrual bleeding? Does it improve hormonal markers associated with FHA recovery? To answer these questions, researchers will compare the 10-week psychoeducational intervention with treatment as usual (TAU). This comparison will help determine whether the structured program leads to faster or more reliable recovery of menstrual and endocrine function than the care women typically receive today.
Participants will:
Take part in a 10-week psychoeducational program focusing on health behaviors important for FHA recovery (intervention group) or receive treatment as usual (comparison group) Complete questionnaires and health assessments Provide blood samples to measure hormone levels Take part in a gynecological exam to monitor ovary activity and endometrial thickness Be followed for 9 months after the program to track progress This study builds on a previous feasibility study and will help determine whether the intervention is effective and should be used more widely to support women with FHA.
详细描述
The study a randomized, controlled, multicentre trial evaluating a 10-week psychoeducational health and lifestyle intervention with a 9-month follow-up period in women with Functional Hypothalamic Amenorrhea (FHA).
Background and Significance FHA is a functional endocrine condition that can be reversed through behavioural and lifestyle changes. A structured psychoeducational program may support these changes by improving knowledge, motivation, and self-management skills. The intervention will be compared with treatment as usual (TAU) to determine whether it leads to superior restoration of menstrual and endocrine function.
Study Aim The aim of this study is to evaluate whether a 10-week psychoeducational intervention is effective in restoring menstrual and endocrine function in women with FHA.
Study Setting and Participants A total of 70 women with FHA will be recruited following the same procedures used in Study 1. Participants who meet inclusion criteria and provide informed consent will enter the trial. Those who meet exclusion criteria will receive appropriate clinical information, standard care, or referral to relevant healthcare services.
Power Analysis The sample size calculation is based on findings from a previous trial evaluating an individualized Cognitive Behavioural Therapy (CBT) intervention, where ovarian recovery occurred in 87.5% of participants receiving CBT compared with 33% in the observation group. For the current trial, the psychoeducational intervention is expected to yield a slightly lower effect (estimated 70% recovery). With 80% power and α = 0.05, 28 participants per group are required to detect this difference. Allowing for up to 15% attrition, the study will recruit 35 participants per arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •aged 18-42 years
- •fulfill criteria for diagnosis of functional hypothalamic amenorrhea (hypogonadotropic hypogonadism)
- •basic proficiency in Swedish
- •access to a computer.
排除标准
- •Lack of proficiency in language
- •evere psychiatric co-morbidity e.g. psychosis or active eating disorders (anorexia nervosa).
研究组 & 干预措施
Psychoeducational Intervention
Participants in this arm will take part in a 10-week psychoeducational health and lifestyle program designed to support behavioural change related to recovery from Functional Hypothalamic Amenorrhea (FHA). The intervention includes weekly modules focusing on nutrition, exercise behaviours, stress management, and recovery-promoting habits, delivered with evidence-based educational content and practical exercises. Participants will also complete questionnaires and provide blood samples at scheduled timepoints and will be followed for 9 months after the intervention.
干预措施: Psychoeducaction or treatment as usual (Behavioral)
Treatment as Usual (TAU)
Participants in this arm will receive treatment as usual for Functional Hypothalamic Amenorrhea, which may include general clinical advice, routine follow-up, and standard information provided by healthcare services. No structured psychoeducational program will be offered. Participants will complete questionnaires and provide blood samples at the same timepoints as the intervention group.
干预措施: Treatment as usual (TAU) (Other)
结局指标
主要结局
Number of participants with return of spontaneous menstrual bleeding within 9 months
时间窗: Restoration of menstruation after 9 months of follow-up
Restoration of menstruation is defined as a spontaneous menstrual bleed observed reported by the participants. Hormonal assessment will occur on cycle day 21 of the next menstrual cycle following intervention. The outcome will be reported as the number and proportion of participants who experience menstrual restoration.
Change in serum FSH, LH, and estradiol
时间窗: 12 months
For participants who have not experienced menstruation during follow-up serum FSH, LH, and estradiol levels will be measured to evaluate hormonal improvement. Changes from baseline will be reported as mean ± SD and as the proportion of participants showing increase in estradiol consistent with improved ovarian function.
次要结局
未报告次要终点
研究者
Hedvig Engberg
Assistant Professor
Karolinska Institutet