A 10-Week Online Education Program for Women With Functional Hypothalamic Amenorrhea: Developing and Testing Feasibility and Acceptability (HEAL FHA Pilot)

A 10-Week Online Education Program for Women With Functional Hypothalamic Amenorrhea: Developing and Testing Feasibility and Acceptability of HEAL FHA

This study is a single-arm feasibility trial evaluating a 10-week web-based psychoeducational intervention for women with functional hypothalamic amenorrhea (FHA). The primary aim is to assess feasibility and acceptability prior to a future randomized controlled trial.

Study Overview

• Status: Active, not recruiting
• Conditions: Functional Hypothalamic Amenorrhea
• Intervention / Treatment: Behavioral: 10-week web-based psychoeducational program

Detailed Description

Intervention The intervention is delivered via a secure web-based platform over 10 weeks. It consists of sequentially released modules including psychoeducational content, reflective exercises, and practical strategies targeting factors relevant to FHA, including energy availability, stress regulation, recovery, nutrition, physical activity, and psychological well-being. The program is self-guided and designed for remote access. No therapist support is provided within the platform.

The intervention content has been developed through an iterative co-creation process involving clinicians (gynecology, psychology, physiotherapy, dietetics) and patient representatives.

Study procedures and setting Participants are recruited via self-referral or clinical referral from gynecological outpatient services. All participants undergo baseline clinical assessment at the Gynecological Endocrinology Clinic at Karolinska University Hospital to confirm diagnosis of FHA prior to enrollment.

Assessments are conducted at baseline (T0), post-intervention at 10 weeks (T1), and follow-up at 4 weeks post-intervention (T2).

At baseline, diagnosis is confirmed through clinical evaluation, medical history, gynecological examination, and hormonal assessment consistent with hypogonadotropic hypogonadism. Psychiatric comorbidity is assessed using the Mini-International Neuropsychiatric Interview (MINI).

Self-report questionnaires are completed electronically via REDCap at T0 and T1, assessing psychological and behavioral outcomes including perceived stress, coping, anxiety, depressive symptoms, eating-related behaviors, exercise patterns, and personality-related traits associated with FHA.

Outcomes Primary outcomes include feasibility and acceptability metrics: recruitment rate, retention, intervention completion, adherence to modules, and participant satisfaction.

Secondary outcome includes change in luteinizing hormone (LH) levels from baseline to post-intervention as a physiological marker of hypothalamic-pituitary-gonadal axis activity.

Exploratory outcomes include changes in psychological and behavioral measures from baseline to post-intervention and follow-up.

Statistical analysis Descriptive statistics will be used to summarize feasibility outcomes. Changes in continuous outcomes will be analyzed using paired t-tests or Wilcoxon signed-rank tests as appropriate. Missing data will be handled using multiple imputation. Analyses will be conducted using IBM SPSS Statistics.

Ethical considerations Participants not meeting eligibility criteria or requiring additional clinical care will be referred to appropriate healthcare services. The study is conducted in accordance with applicable ethical guidelines for human research.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Female participants aged 18-40 years Clinical diagnosis of functional hypothalamic amenorrhea (hypogonadotropic hypogonadism) confirmed by clinical assessment Ability to understand and read Swedish Access to a computer and internet connection Willing and able to provide informed consent

Exclusion Criteria:

Current or past diagnosis of anorexia nervosa Severe psychiatric comorbidity (e.g., psychotic disorders) that may interfere with study participation Inability to understand or read Swedish Medical or gynecological conditions other than FHA that explain amenorrhea

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Web-Based Psychoeducational Intervention; Participants will complete a 10-week web-based psychoeducational intervention for functional hypothalamic amenorrhea, with assessments at baseline, post-treatment, and 4-week follow-up.	Behavioral: 10-week web-based psychoeducational program; The intervention is a 10-week, self-guided, web-based psychoeducational program targeting biopsychosocial mechanisms underlying functional hypothalamic amenorrhea, including stress, energy availability, and exercise-related behaviors. Content was developed by a multidisciplinary clinical team in collaboration with patient representatives.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant satisfaction	Self-reported satisfaction with the intervention assessed post-treatment using a standardized questionnaire. (Unit of Measure: score on satisfaction scale)	Post-treatment (10 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Recruitment rate 2. Retention rate 3. Intervention completion rate 4. Perceived usefulness of intervention	Proportion of eligible participants who consent to participate in the study. (Unit of Measure: percentage of eligible participants); Proportion of participants completing post-treatment assessment at 10 weeks. (Unit of Measure: percentage of enrolled participants); Proportion of participants completing all 10 modules of the web-based program. (Unit of Measure: percentage of enrolled participants); Participant-rated perceived usefulness of the program assessed post-treatment using a standardized rating scale. (Unit of Measure: scale score)	From enrollment to the end of treatment at 10 weeks

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital; FoU Centrum, Landstinget Sörmland

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: secondary amenorrhea; relative energy deficiency; functional hypogonadotropic hypogonadism; the female athlete triad
• Other Study ID Numbers: 2023-05586-01 Pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No