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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Stockholm, Suécia
- Karolinska University Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Participant satisfaction
Prazo: Post-treatment (10 weeks)
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Self-reported satisfaction with the intervention assessed post-treatment using a standardized questionnaire. (Unit of Measure: score on satisfaction scale) |
Post-treatment (10 weeks)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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1. Recruitment rate 2. Retention rate 3. Intervention completion rate 4. Perceived usefulness of intervention
Prazo: From enrollment to the end of treatment at 10 weeks
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From enrollment to the end of treatment at 10 weeks
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 2023-05586-01 Pilot
Plano para dados de participantes individuais (IPD)
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