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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Stockholm、スウェーデン
- Karolinska University Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Participant satisfaction
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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1. Recruitment rate 2. Retention rate 3. Intervention completion rate 4. Perceived usefulness of intervention
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2023-05586-01 Pilot
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。