Feasibility of a 10-week self-guided digital program for functional hypothalamic amenorrhea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm feasibility study of a 10-week, web-based psychoeducational program designed for women with functional hypothalamic amenorrhea. The intervention is delivered remotely through a secure platform with weekly modules that cover energy balance, stress, nutrition, physical activity, and wellbeing, without therapist support. Participants are recruited from gynecology clinics and confirmed to have FHA using clinical evaluation and hormonal assessment, then complete assessments at baseline, after 10 weeks, and 4 and 8 weeks post-intervention. The study aims to determine feasibility and acceptability, rather than clinical efficacy, in preparation for a future randomized trial. Data include clinical, hormonal, and DIAMOND psychiatric interviews, plus self-report measures to track changes over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Women aged 18-40 years with functional hypothalamic amenorrhea (hypogonadotropic hypogonadism) verified by a gynecologist; able to read and understand Swedish; access to an internet-enabled device and BankID; written informed consent.

Exclusion Criteria:

Current anorexia nervosa, bulimia nervosa or binge-eating disorder according to the DIAMOND structured diagnostic interview (other specified feeding or eating disorder is not an exclusion criterion); severe psychiatric comorbidity requiring other or more intensive care, including psychosis; insufficient Swedish proficiency; other causes of amenorrhea, including pregnancy, thyroid disease, hyperprolactinemia and polycystic ovary syndrome.

Where it's running

• Women's Health Clinic, Karolinska University Hospital
  Stockholm, Stockholm County, Sweden Recruiting
• Karolinska University Hospital
  Stockholm, Sweden Recruiting

Study contacts

• Study coordinator: Hedvig Engberg, MD, Associate Professor
• Email: hedvig.engberg@ki.se
• Phone: +46 08 123 700 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.