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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Hedvig Engberg, MD, Associate Professor
- Telefoonnummer: +46 08 123 700 00
- E-mail: hedvig.engberg@ki.se
Studie Contact Back-up
- Naam: Anna Strandqvist, PhD, clinical psychologist
- E-mail: anna.strandqvist@ki.se
Studie Locaties
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Stockholm, Zweden
- Werving
- Karolinska University Hospital
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Contact:
- Hedvig Engberg, MD PhD
- Telefoonnummer: +46 08 123 700 00
- E-mail: hedvig.engberg@ki.se
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Contact:
- Anna Strandqvist, PhD
- Telefoonnummer: +46 08 123 700 00
- E-mail: anna.strandqvist@ki.se
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Hoofdonderzoeker:
- Hedvig Engberg, MD PhD
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Stockholm County
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Stockholm, Stockholm County, Zweden, 17176
- Werving
- Women's Health Clinic, Karolinska University Hospital
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Contact:
- Hedvig Engberg, MD PhD
- Telefoonnummer: +46 08 123 70 000
- E-mail: hedvig.engberg@ki.se
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Participant satisfaction
Tijdsspanne: Post-treatment (10 weeks)
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Post-treatment (10 weeks)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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1. Recruitment rate 2. Retention rate 3. Intervention completion rate 4. Perceived usefulness of intervention
Tijdsspanne: From enrollment to the end of study after 4 months
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From enrollment to the end of study after 4 months
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Psychiatric co-morbidity
Tijdsspanne: At enrollment and at study end
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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
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 2023-05586-01 Pilot
- 2023 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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