Functional Hypothalamic AmenorrheaHEAL FHA PilotNCT07589868
Feasibility of a Digital Self-help Program for Functional Hypothalamic Amenorrhea (HEAL-FHA Pilot)
A study testing 10-week web-based psychoeducational program in people with Functional Hypothalamic Amenorrhea, run by Karolinska Institutet at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Functional Hypothalamic Amenorrhea
- What is being tested?
- 10-week web-based psychoeducational program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesSweden
- Study dates
- 2 Nov 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anna Strandqvist, PhD, clinical psychologist contact
Sweden2 sites, 2 recruiting
- Recruiting
Women's Health Clinic, Karolinska University Hospital
Stockholm, Stockholm County, 17176
Hedvig Engberg, MD PhD, +46 08 123 70 000, hedvig.engberg@ki.se
- Recruiting
Karolinska University Hospital
Stockholm
Hedvig Engberg, MD PhD, +46 08 123 700 00, hedvig.engberg@ki.se
Anna Strandqvist, PhD, +46 08 123 700 00, anna.strandqvist@ki.se
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Functional Hypothalamic Amenorrhea
- Being tested
- 10-week web-based psychoeducational program
- Keywords
- secondary amenorrhea, functional hypogonadotropic hypogonadism, relative energy deficiency, the female athlete triad
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10-week web-based psychoeducational programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Web-Based Psychoeducational Intervention | Experimental | 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. Receives: Behavioral: 10-week web-based psychoeducational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant satisfaction
- Recruitment: number screened, eligible and enrolled, and proportion of eligible women who consent [Time frame: October 2026-March 2027].
- Retention: proportion of enrolled participants completing the 4-month assessment [4 months].
- Adherence: number of modules completed and proportion completing at least 5 of 10 modules (platform log data) [10 weeks].
- Treatment satisfaction: Client Satisfaction Questionnaire (CSQ-8) [3 months].
Measured: Post-treatment (10 weeks)
Secondary outcomes (1)
1. Recruitment rate 2. Retention rate 3. Intervention completion rate 4. Perceived usefulness of intervention
- Proportion of eligible participants who consent to participate in the study. (Unit of Measure: percentage of eligible participants)
- Proportion of participants completing post-treatment assessment at 10 weeks. (Unit of Measure: percentage of enrolled participants)
- Proportion of participants completing all 10 modules of the web-based program. (Unit of Measure: percentage of enrolled participants)
- Participant-rated perceived usefulness of the program assessed post-treatment using a standardized rating scale. (Unit of Measure: scale score) 5 . Treatment credibility [3 weeks].
- Negative effects: Negative Effects Questionnaire (NEQ-20) [3 months].
Measured: From enrollment to the end of study after 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start2 Nov 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Hypothalamic AmenorrheaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, FoU Centrum, Landstinget Sörmland
- Responsible party
- Principal investigator, Hedvig Engberg, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589868
- Sponsor's protocol ID
- 2023-05586-01 Pilot
- Other IDs
- 2023
- Acronym
- HEAL FHA Pilot
- Status last verified
- Nov 2026
- First submitted
- 17 Feb 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Digital Psychoeducational Self-help Program for Women With Functional Hypothalamic Amenorrhea: a Single-arm Pilot Study (HEAL-FHA Pilot)
- ClinicalTrials.gov ID
- NCT07589868
- Acronym / sponsor ID
- HEAL FHA Pilot / 2023-05586-01 Pilot
- Conditions
- Functional Hypothalamic Amenorrhea
- Keywords
- secondary amenorrhea, functional hypogonadotropic hypogonadism, relative energy deficiency, the female athlete triad
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, FoU Centrum, Landstinget Sörmland
- Study start
- 2 Nov 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Web-Based Psychoeducational Intervention | Experimental | Behavioral: 10-week web-based psychoeducational programParticipants will complete a 10-week web-based psychoeducational intervention for functional hypothalamic amenorrhea, with assessments at baseline, post-treatment, and 4-week follow-up. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10-week web-based psychoeducational programThe 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. | Behavioural | Web-Based Psychoeducational Intervention |
Primary outcome
Participant satisfaction
Time frame: Post-treatment (10 weeks)
1. Recruitment: number screened, eligible and enrolled, and proportion of eligible women who consent [Time frame: October 2026-March 2027]. 2. Retention: proportion of enrolled participants completing the 4-month assessment [4 months]. 3. Adherence: number of modules completed and proportion completing at least 5 of 10 modules (platform log data) [10 weeks]. 4. Treatment satisfaction: Client Satisfaction Questionnaire (CSQ-8) [3 months].
1 secondary outcome
1. Recruitment rate 2. Retention rate 3. Intervention completion rate 4. Perceived usefulness of intervention
Time frame: From enrollment to the end of study after 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Strandqvist, PhD, clinical psychologist contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10-week web-based psychoeducational program in people with Functional Hypothalamic Amenorrhea, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hedvig Engberg, MD, Associate Professor (+46 08 123 700 00, hedvig.engberg@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant satisfaction (time frame: Post-treatment (10 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.