Functional Hypothalamic Amenorrhea
Conditions
Keywords
secondary amenorrhea, functional hypogonadotropic hypogonadism, relative energy deficiency, the female athlete triad
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.
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.
Interventions
BEHAVIORAL10-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.
Sponsors
Karolinska Institutet
Karolinska University Hospital
FoU Centrum, Landstinget Sörmland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant satisfaction | Post-treatment (10 weeks) | Self-reported satisfaction with the intervention assessed post-treatment using a standardized questionnaire. (Unit of Measure: score on satisfaction scale) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1. Proportion of eligible participants who consent to participate in the study. (Unit of Measure: percentage of eligible participants) 2. Proportion of participants completing post-treatment assessment at 10 weeks. (Unit of Measure: percentage of enrolled participants) 3. Proportion of participants completing all 10 modules of the web-based program. (Unit of Measure: percentage of enrolled participants) 4. Participant-rated perceived usefulness of the program assessed post-treatment using a standardized rating scale. (Unit of Measure: scale score) |
Countries
Sweden
Outcome results
None listed