FatigueNCT06341751
Psychological Treatment for Persistent Fatigue
A study testing Psychological treatment for persistent fatigue in people with Fatigue and Fatigue Syndrome, Chronic, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This is a non-randomized pilot study to investigate the feasibility and acceptability of a transdiagnostic psychological intervention for primary care patients in Region Stockholm, Sweden, who suffer from persistent and disabling fatigue. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Fatigue, Fatigue Syndrome, Chronic, Exhaustion; Syndrome
- What is being tested?
- Psychological treatment for persistent fatigue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- 11 Apr 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-67
- severe, functionally disabling fatigue as a central symptom for at least 3 months
- The fatigue is not a direct effect of an active disease process motivating another treatment (e.g., hypo-/hyperthyroidism, anemia, cancer, dementia) or the effect of medication
- regular access to a computer and to the Internet
- ability to read and write in Swedish.
Who cannot join
- substance abuse disorder in the past 6 months
- Current or past psychosis or bipolar disorder
- Primary psychiatric disorder of such severity that it merits evidence-based treatment (e.g., obsessive compulsive disorder, moderate to severe depression, post-traumatic stress disorder)
- elevated risk for suicide
- anorexia nervosa
- BMI>40
Show all 13Show fewer
- Initiated or changed psychopharmacological medication (e.g., for depression or anxiety disorders) in the past month
- ongoing chemotherapy
- intellectual disability (e.g., severe autism) that affects ability to work with the treatment
- self-harm
- pregnancy
- life circumstances that complicate or make treatment impossible (e.g., domestic violence or ongoing legal disputes)
- ongoing psychological treatment and/or multimodal rehabilitation.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Gustavsberg University Primary Care Clinic
Stockholm, Stockholm County, 134 40
About this study
Official title: Psychological Treatment for Persistent Fatigue: a Feasibility Study
This is a non-randomized pilot study to investigate the feasibility and acceptability of a transdiagnostic psychological intervention for primary care patients in Region Stockholm, Sweden, who suffer from persistent and disabling fatigue.
Read the detailed description
Previous research indicates that fatigue is a transdiagnostic symptom dimension rather than a disorder-specific pathofysiology. Similar psychosocial mechanisms can contribute to the development and perpetuation of fatigue across medical conditions. Cognitive and behavioral interventions targeting these perpetuating mechanisms have been found effective in reducing fatigue severity and functional impairment in a range of different fatigue-dominated diagnostic groups. Based on these findings, the investigators have developed a transdiagnostic intervention for primary care patients who suffer from persistent fatigue, independent of primary diagnosis. The treatment is a psychological intervention based on cognitive and behavioral principles that is administered over a period of 4-6 months. Treatment material will be delivered via an online treatment platform and therapist support will be given both face-to-face and via written asynchronous text-messages in the online treatment platform.
This initial feasibility study is non-randomized, meaning that all included patients will recieve treatment.
The project could provide feasibility of a transdiagnostic treatment for primary care patients with severe and persistent fatigue across medical conditions. If the inclusion procedure, the data-collection procedure, and the treatment are feasible, a larger randomized clinical trial (RCT) studying treatment effect is called for. An adequately powered RCT could provide firm scientific support for a novel, scalable, and cost-effective way to deliver an evidence-based treatment for this large and currently under-treated patient group. This would have a desirable impact on patients, families, healthcare units, and society at large, given that fatigue is associated with substantial suffering and work-disability and that treatment guidelines are currently lacking.
- Conditions
- Fatigue, Fatigue Syndrome, Chronic, Exhaustion; Syndrome
- Being tested
- Psychological treatment for persistent fatigue
- Keywords
- Psychological treatment, Primary care, cognitive behavioral therapy, internet intervention, feasibility
- Medical subject headings
- Fatigue, Fatigue Syndrome, Chronic, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological treatment for persistent fatigueBehavioural
The treatment consists of three main phases: 1) goal-setting; stabilizing sleep-wake patterns and even distribution of activities over the day (pacing). Attention-shifting and cognitive reappraisal 2. Gradual increase in physical activity followed by gradual increase in mental and social activity 3. Individual work to reach treatment goals.
| Study group | Role | What they receive |
|---|---|---|
| Psychological treatment | Experimental | Blended treatment, i.e., both physical face-to-face sessions and internet-based asynchronous support. Treatment period is 4-6 months (6 months primary endpoint). Receives: Behavioral: Psychological treatment for persistent fatigue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment adherence and completion
Treatment adherence will be assessed by evaluating how many sessions (face-to-face and video-based) the patient received, how many modules of the internet-delivered material the patient accessed, and the amount of time the patient spent in the online treatment platform (data extracted from the platform).
Further, number of drop-outs (i.e., patients who discontinued treatment before treatment completion) will be analyzed
Measured: Post-treatment (6 months)
Treatment credibility
Assessed using the Credibility/Expectancy Questionnaire (C-Scale). The C-Scale is a 5-item measure, scale range is 0 to 50 points with higher scores indicating higher treatment credibility.
Measured: Three weeks after treatment start
Patient satisfaction
Client Satisfaction Questionnaire (CSQ-8). Total scores range from 8 to 32, with higher scores indicating greater treatment satisfaction.
Measured: Post-treatment (6 months)
Working alliance
Assessed using the Working Alliance Questionnaire (WAI - short version). Scale range is from 6 to 42 with higher scores indicating a better percieved working alliance.
Measured: Week 3 and 15 of treatment
Negative effects of treatment
The Negative Effects of Treatment Questionnaire (NEQ-20). The self-report measure consists of three parts. First, respondents endorse specific items in case they have occurred or not during treatment, yes/no (dummy coded as a variable: 1/0). Second, the respondents rate how negatively the negative effect was on four-point Likert-scale, ranging from "Not at all" to "Extremely", 0-4 ("0" being minimum and "4" being maximum). Third, the respondents attribute the negative effect to "The treatment I received" (1) or "Other circumstances" (0) (dummy coded as a variable: 1/0).
Measured: Post-treatment (6 months)
Open-ended questions regarding treatment content and presentation
Post-treatment, patients will be asked open-ended questions regarding their perception of the different components of the treatment, how much time they spent working with the treatment, and their thoughts about the usability of the digital platform.
Measured: Post-treatment (6 months)
Secondary outcomes (16)
Feasibility of study inclusion procedures and data-collection
The recruitment procedure will be evaluated by accessing data from ALMA (a fully automated clinical desicion-support in the medical journal). ALMA aggregates anonymous data regarding number of times the algorithm has been activated and the number of times it has resulted in a referral to the study platform where screening for study inclusion is completed. Of those who complete screening, we will assess the proportion of patients who are included or excluded in the study.
Data-collection procedures will be assessed by evaluating data-attrition at the various measurement points.
Measured: Data will be collected during the recruitment and inclusion phase of the study.
Fatigue severity, primary self-rated symptom outcome
Fatigue severity (self-rated) using the Checklist Individual Strenghts- Fatigue severity subscale. The domain Fatigue severity contains 8 items scored on a 7-point Likert scale (range 8-56; higher scores=more severe fatigue). A score above 35 points on the CIS-F indicates severe fatigue.
Measured: Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.
Problems concentrating
Subscale in the Checklist Individual Strengths Questionnaire (CIS), 5 items. Scale range: 5 to 35 with higher scores representing more problems concentrating.
Measured: Assessed pre- and at post treatment (6 months)
Reduced physical activity
Subscale in the Checklist Individual Strengths Questionnaire (CIS), 3 items. Scale range: 3 to 21 with higher scores representing less physical activity.
Measured: Assessed pre- and at post treatment (6 months)
Reduced motivation
Subscale in the Checklist Individual Strengths Questionnaire (CIS), 4 items. Scale range: 4 to 28 with higher scores representing less motivation.
Measured: Assessed pre- and at post treatment (6 months)
Depressive symptoms
Patient Health Questionnaire-9 (PHQ-9). Scale range is from 0 to 27, higher scores representing more depressive symptoms Note: the suicide-item will be administered every three weeks during the treatment phase.
Measured: Assessed pre- and at post treatment (6 months). The individual item assessing suicide risk will be administered every 3 weeks during the traetment phase.
Somatic symptoms
Physical Health Questionnaire-15 (PHQ-15). Scale range is from 0 to 30, higher scores representing more somatic symptoms
Measured: Assessed pre- and at post treatment (6 months)
General anxiety
The General Anxiety Questionnaire (GAD-7). Scale range is from 0 to 21, higher scores representing more anxiety.
Measured: Assessed pre- and at post treatment (6 months)
Insomnia
The Insomnia Severity Inventory (ISI) 7 items. Scale range is from 0 to 28, higher scores representing higher insomnia severity.
NOTE: an additional item will be added to assess hypersomnia.
Measured: Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.
Perceived Stress
The Perceived Stress Scale (PSS-10). Scale range is from 0 to 40, higher scores representing a higher level of perceived stress.
Measured: Assessed pre- and at post treatment (6 months)
Burnout
The Shirom-Melamed Burnout Questionnaire (SMBQ-18). Scale range is from 0 to 6, higher scores representing a higher level of burnout.
Measured: Assessed pre- and at post treatment (6 months)
Self-rated health
The Self-rated health questionnaire (SRH-5). A single item with 5 response-categories, 0 (very bad health); 4 (very good health)
Measured: Assessed pre- and at post treatment (6 months)
Cognitive and behavioral responses to symptoms
Cognitive and Behavioral Responses to Symptoms Questionnaire (CBRQ), 18-items. The scale assesses six domains: Fear avoidance (3 items, scale range 0-12); Damage beliefs (3 items, scale range 0-12); Embarrassment avoidance (3 items, scale range 0-12); Symptom focusing (3 items, scale range 0-12); All-or-nothing behaviour (3 items, scale range 0-12); Resting behaviour (3 items, scale range 0-12).
Measured: Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.
General self-efficacy
The General self-efficacy scale (GSE), 10 items. Scale range is from 10 to 40, higher scores representing a higher level of self-efficacy.
Measured: Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.
Functional disability
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), 12 items. Scoring from 0 (maximum functional disability) to 100 (no functional disability)
Measured: Assessed pre- and at post treatment (6 months)
Work and Social Adjustment
the Work and Social Adjustment Scale (WSAS), 5 items. Scale range 0 to 40 with higher scores representing better work and social adjustment.
Measured: Assessed pre- and at post treatment (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start11 Apr 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Forte, The Swedish Research Council, Region Stockholm
- Responsible party
- Principal investigator, Elin Lindsäter, Karolinska Institutet
- Investigators
- Elin Lindsäter, PhD, Principal investigator, Region Stockholm and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341751
- Sponsor's protocol ID
- 2024-00393-01
- Status last verified
- Jul 2024
- First submitted
- 13 Mar 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Svardman F, Samuelsson C, Foyen LF, Oremark A, Hogfeldt A, Emad JA, Sjowall D, Ruck C, Hedman-Lagerlof E, Knoop H, Lindsater E. Transdiagnostic cognitive behavioral therapy for severe and persistent fatigue - a feasibility study in primary care. BMC Prim Care. 2026 Apr 29;27(1):168. doi: 10.1186/s12875-026-03346-x.
PubMed 42056913
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Treatment for Persistent Fatigue: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06341751
- Acronym / sponsor ID
- 2024-00393-01
- Conditions
- Fatigue, Fatigue Syndrome, Chronic, Exhaustion; Syndrome
- Keywords
- Psychological treatment, Primary care, cognitive behavioral therapy, internet intervention, feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Forte, The Swedish Research Council, Region Stockholm
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 2 Apr 2024 (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 is a non-randomized pilot study to investigate the feasibility and acceptability of a transdiagnostic psychological intervention for primary care patients in Region Stockholm, Sweden, who suffer from persistent and disabling fatigue.
Detailed description
Previous research indicates that fatigue is a transdiagnostic symptom dimension rather than a disorder-specific pathofysiology. Similar psychosocial mechanisms can contribute to the development and perpetuation of fatigue across medical conditions. Cognitive and behavioral interventions targeting these perpetuating mechanisms have been found effective in reducing fatigue severity and functional impairment in a range of different fatigue-dominated diagnostic groups. Based on these findings, the investigators have developed a transdiagnostic intervention for primary care patients who suffer from persistent fatigue, independent of primary diagnosis. The treatment is a psychological intervention based on cognitive and behavioral principles that is administered over a period of 4-6 months. Treatment material will be delivered via an online treatment platform and therapist support will be given both face-to-face and via written asynchronous text-messages in the online treatment platform.
This initial feasibility study is non-randomized, meaning that all included patients will recieve treatment.
The project could provide feasibility of a transdiagnostic treatment for primary care patients with severe and persistent fatigue across medical conditions. If the inclusion procedure, the data-collection procedure, and the treatment are feasible, a larger randomized clinical trial (RCT) studying treatment effect is called for. An adequately powered RCT could provide firm scientific support for a novel, scalable, and cost-effective way to deliver an evidence-based treatment for this large and currently under-treated patient group. This would have a desirable impact on patients, families, healthcare units, and society at large, given that fatigue is associated with substantial suffering and work-disability and that treatment guidelines are currently lacking.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychological treatment | Experimental | Behavioral: Psychological treatment for persistent fatigueBlended treatment, i.e., both physical face-to-face sessions and internet-based asynchronous support. Treatment period is 4-6 months (6 months primary endpoint). |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 18-67
- severe, functionally disabling fatigue as a central symptom for at least 3 months
- The fatigue is not a direct effect of an active disease process motivating another treatment (e.g., hypo-/hyperthyroidism, anemia, cancer, dementia) or the effect of medication
- regular access to a computer and to the Internet
- ability to read and write in Swedish.
Key exclusion criteria (13 listed)
- substance abuse disorder in the past 6 months
- Current or past psychosis or bipolar disorder
- Primary psychiatric disorder of such severity that it merits evidence-based treatment (e.g., obsessive compulsive disorder, moderate to severe depression, post-traumatic stress disorder)
- elevated risk for suicide
- anorexia nervosa
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 |
|---|---|---|
| Psychological treatment for persistent fatigueThe treatment consists of three main phases: 1) goal-setting; stabilizing sleep-wake patterns and even distribution of activities over the day (pacing). Attention-shifting and cognitive reappraisal 2. Gradual increase in physical activity followed by gradual increase in mental and social activity 3. Individual work to reach treatment goals. | Behavioural | Psychological treatment |
Primary outcome
Treatment adherence and completion
Time frame: Post-treatment (6 months)
Treatment adherence will be assessed by evaluating how many sessions (face-to-face and video-based) the patient received, how many modules of the internet-delivered material the patient accessed, and the amount of time the patient spent in the online treatment platform (data extracted from the platform). Further, number of drop-outs (i.e., patients who discontinued treatment before treatment completion) will be analyzed
Treatment credibility
Time frame: Three weeks after treatment start
Assessed using the Credibility/Expectancy Questionnaire (C-Scale). The C-Scale is a 5-item measure, scale range is 0 to 50 points with higher scores indicating higher treatment credibility.
Patient satisfaction
Time frame: Post-treatment (6 months)
Client Satisfaction Questionnaire (CSQ-8). Total scores range from 8 to 32, with higher scores indicating greater treatment satisfaction.
Working alliance
Time frame: Week 3 and 15 of treatment
Assessed using the Working Alliance Questionnaire (WAI - short version). Scale range is from 6 to 42 with higher scores indicating a better percieved working alliance.
Negative effects of treatment
Time frame: Post-treatment (6 months)
The Negative Effects of Treatment Questionnaire (NEQ-20). The self-report measure consists of three parts. First, respondents endorse specific items in case they have occurred or not during treatment, yes/no (dummy coded as a variable: 1/0). Second, the respondents rate how negatively the negative effect was on four-point Likert-scale, ranging from "Not at all" to "Extremely", 0-4 ("0" being minimum and "4" being maximum). Third, the respondents attribute the negative effect to "The treatment I received" (1) or "Other circumstances" (0) (dummy coded as a variable: 1/0).
Open-ended questions regarding treatment content and presentation
Time frame: Post-treatment (6 months)
Post-treatment, patients will be asked open-ended questions regarding their perception of the different components of the treatment, how much time they spent working with the treatment, and their thoughts about the usability of the digital platform.
16 secondary outcomes
Feasibility of study inclusion procedures and data-collection
Time frame: Data will be collected during the recruitment and inclusion phase of the study.
Fatigue severity, primary self-rated symptom outcome
Time frame: Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.
Problems concentrating
Time frame: Assessed pre- and at post treatment (6 months)
Reduced physical activity
Time frame: Assessed pre- and at post treatment (6 months)
Reduced motivation
Time frame: Assessed pre- and at post treatment (6 months)
Depressive symptoms
Time frame: Assessed pre- and at post treatment (6 months). The individual item assessing suicide risk will be administered every 3 weeks during the traetment phase.
Somatic symptoms
Time frame: Assessed pre- and at post treatment (6 months)
General anxiety
Time frame: Assessed pre- and at post treatment (6 months)
Insomnia
Time frame: Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.
Perceived Stress
Time frame: Assessed pre- and at post treatment (6 months)
Burnout
Time frame: Assessed pre- and at post treatment (6 months)
Self-rated health
Time frame: Assessed pre- and at post treatment (6 months)
Cognitive and behavioral responses to symptoms
Time frame: Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.
General self-efficacy
Time frame: Assessed pre- and at post treatment (6 months), and every three weeks during the treatment phase.
Functional disability
Time frame: Assessed pre- and at post treatment (6 months)
Work and Social Adjustment
Time frame: Assessed pre- and at post treatment (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Derived from this study: PubMed 42056913Svardman F, Samuelsson C, Foyen LF, Oremark A, Hogfeldt A, Emad JA, Sjowall D, Ruck C, Hedman-Lagerlof E, Knoop H, Lindsater E. Transdiagnostic cognitive behavioral therapy for severe and persistent fatigue - a feasibility study in primary care. BMC Prim Care. 2026 Apr 29;27(1):168. doi: 10.1186/s12875-026-03346-x.
Related trials for Fatigue
Not yet recruitingObservational study
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
Primary Biliary Cholangitis (PBC)
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
Not yet recruiting
Effect of Baduanjin Exercise on Pain, Fatigue, and Quality of Recovery After Abdominal Surgery
Abdominal Surgery, Baduanjin
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Not yet recruiting
A Clinical Trial to Evaluate the Effects of A Supplement on Symptoms of Menopause and Overall Well-being
Menopause, Menopausal Symptoms
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. This study is not recruiting at the moment.
Elin Lindsäter, PhD principal investigator
Region Stockholm and Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological treatment for persistent fatigue in people with Fatigue and Fatigue Syndrome, Chronic, run by Karolinska Institutet at 1 site 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment adherence and completion (time frame: Post-treatment (6 months)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06341751, which also lists 1 linked publication.
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 3 Jun 2025.