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

NCT07589868 | Active Not Recruiting

• 1 other identifier: 2023-05586-01 Pilot
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Functional Hypothalamic Amenorrhea

Keywords

secondary amenorrhea; functional hypogonadotropic hypogonadism; relative energy deficiency; the female athlete triad

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 1. Recruitment rate 2. Retention rate 3. Intervention completion rate 4. Perceived usefulness of intervention

  From enrollment to the end of treatment at 10 weeks

Study Arms (1)

Web-Based Psychoeducational Intervention

EXPERIMENTAL

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

Interventions

10-week web-based psychoeducational program BEHAVIORAL

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.

Web-Based Psychoeducational Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator
• FoU Centrum, Landstinget Sörmland: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: May 15, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

SE (1)