Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot) (HEAL FHA Pilot)
Feasibility and Acceptability of a Digital Psychoeducational Self-help Program for Women With Functional Hypothalamic Amenorrhea: a Single-arm Pilot Study (HEAL-FHA Pilot)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Intervention The intervention is delivered via a secure web-based platform over 10 weeks. Delivered via Inera's Stöd och behandling platform (1177) with BankID login; one module per week; no therapist support. 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 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 and 8 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 DIAMOND Psychiatric Interview.
Self-report questionnaires are completed electronically via REDCap at T0, T1 and T2, 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 Analyses are descriptive. Proportions are presented with exact 95% confidence intervals and changes from baseline with 95% confidence intervals; no formal hypothesis testing of effectiveness is planned. Missing data are described and not imputed.
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hedvig Engberg, MD, Associate Professor
- Numéro de téléphone: +46 08 123 700 00
- E-mail: hedvig.engberg@ki.se
Sauvegarde des contacts de l'étude
- Nom: Anna Strandqvist, PhD, clinical psychologist
- E-mail: anna.strandqvist@ki.se
Lieux d'étude
-
-
-
Stockholm, Suède
- Recrutement
- Karolinska University Hospital
-
Contact:
- Hedvig Engberg, MD PhD
- Numéro de téléphone: +46 08 123 700 00
- E-mail: hedvig.engberg@ki.se
-
Contact:
- Anna Strandqvist, PhD
- Numéro de téléphone: +46 08 123 700 00
- E-mail: anna.strandqvist@ki.se
-
Chercheur principal:
- Hedvig Engberg, MD PhD
-
-
Stockholm County
-
Stockholm, Stockholm County, Suède, 17176
- Recrutement
- Women's Health Clinic, Karolinska University Hospital
-
Contact:
- Hedvig Engberg, MD PhD
- Numéro de téléphone: +46 08 123 70 000
- E-mail: hedvig.engberg@ki.se
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Women aged 18-40 years with functional hypothalamic amenorrhea (hypogonadotropic hypogonadism) verified by a gynecologist; able to read and understand Swedish; access to an internet-enabled device and BankID; written informed consent.
Exclusion Criteria:
Current anorexia nervosa, bulimia nervosa or binge-eating disorder according to the DIAMOND structured diagnostic interview (other specified feeding or eating disorder is not an exclusion criterion); severe psychiatric comorbidity requiring other or more intensive care, including psychosis; insufficient Swedish proficiency; other causes of amenorrhea, including pregnancy, thyroid disease, hyperprolactinemia and polycystic ovary syndrome.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Participant satisfaction
Délai: Post-treatment (10 weeks)
|
|
Post-treatment (10 weeks)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
1. Recruitment rate 2. Retention rate 3. Intervention completion rate 4. Perceived usefulness of intervention
Délai: From enrollment to the end of study after 4 months
|
|
From enrollment to the end of study after 4 months
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Psychiatric co-morbidity
Délai: At enrollment and at study end
|
EDE-Q, PSS-14, GAD-7, PHQ-9, WHO-5, ISI, IPAQ and FSFI-6 [baseline and 4 months]; psychiatric diagnoses according to DIAMOND [baseline]. |
At enrollment and at study end
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2023-05586-01 Pilot
- 2023 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .