EmotionsNCT05391295
Mapping Emotional Dynamics During Corticosteroid Treatment
An observational study of Emotions and Corticosteroids, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Synthetic glucocorticoids can result in neuropsychiatric adverse effects in a minority of patients. Although, not all patients experience severe adverse effects, more subtle emotional disturbances are often experienced. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Emotions, Corticosteroids
- What is being tested?
- Short daily questionnaire
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Sep 2022to 28 Jul 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Mycosis fungoides and/or Sezary syndrome patients and cluster headache patients who will be treated according to standard regular care, which is a corticosteroid treatment regime.
Who may be able to join
- Mycosis fungoides and/or Sezary syndrome patients
- Chronic cluster headache patients
- Corticosteroid treatment
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mapping Emotional Dynamics in Cutaneous T-cell Lymphoma (Type Mycosis Fungoides and/or Sezary Syndrome) Patients and Chronic Cluster Headache Patients During Treatment With Corticosteroids: a Case Series Study
Rationale: Synthetic glucocorticoids can result in neuropsychiatric adverse effects in a minority of patients. Although, not all patients experience severe adverse effects, more subtle emotional disturbances are often experienced. With a variation on ecological momentary assessment (EMA), with a daily assessment, the investigators will collect the patient's emotional symptoms in real time and in the patients natural environment during corticosteroid treatment. With dynamic time warping (DTW) analysis the investigators aim to analyse the temporal dynamics of different emotional states and visualize these emotional dynamics over time. The patient dermatologist and neurologist will receive the idiographic results as a feedback form, which may give insights into temporal (and possibly causal) central emotions, which may help to overcome mood disturbances.
Objective: Mapping emotional dynamics with DTW analysis in 6 mycosis fungoides or Sezary syndrome patients and 6 chronic cluster headache patients treated with systemic corticosteroids.
Read more
Study design: Case series report study. Study population: Six patients with cutaneous T-cell lymphoma (type mycosis fungoides and/or Sezary syndrome), and six patients with cluster headache.
Main study parameters/endpoints: An idiographic DTW analysis of emotional dynamics during and after corticosteroid treatment in six mycosis fungoides and/or Sezary syndrome patients, and six chronic cluster headache patients.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no additional risks associated with study participation. The patients who will participate in this case series study need to complete a 5-minute survey daily using a m-Path smartphone app during corticosteroid treatment. The data analysis may increase the insight into centrality measures of emotions and the emotional clusters for the individual patient.
Read the detailed description
This is a case series study in which we want to map emotional dynamics with DTW analysis in 6 mycosis fungoides and/or Sezary syndrome patients and 10 chronic cluster headache patients, who will be treated with a corticosteroid regime. Duration of the study will approximately be 40-60 days, depending on the duration of the treatment:
- The mycosis fungoides and/or Sezary syndrome patients are treated for approximately 40 days.
- The chronic cluster headache patients are treated for approximately 60 days.
The patient will be treated according to standard regular care. This will not change. For study purposes, a 15 minute explanation of the survey will be given. We will ask the patient to install the m-Path app on their smartphone, and to complete the daily survey (with 23 statements with a slider) on his/her phone during the treatment period, which will take approximately 5 minutes per day. At the end of the study the patient will get the results visualized, with a 30 minute explanation of the results, which may increase insights of the patient's emotions dynamics over time during corticosteroid treatment.
- Conditions
- Emotions, Corticosteroids
- Being tested
- Short daily questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short daily questionnaireOther
This study includes 1 survey that needs to be filled out by the patient on his/her phone daily during the course of corticosteroid treatment. The investigators will start the survey few days before the corticosteroid treatment and it will continue till the end of the treatment regime. The treatment regime is regular care and patient specific, but will approximately have a duration of 40 days. In case of prolonged treatment with steroids it is decided to have a limit for our study: either until 7 days after the end of corticosteroid treatment or a maximum of 60 days.
| Study group | Role | What they receive |
|---|---|---|
| 6 CTCL patients, and 10 chronic cluster headache patients | The patients will be treated according to standard regular care, which is a corticosteroid treatment regime. Receives: Other: Short daily questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mapping emotional dynamics with DTW analysis in CTCL patients and cluster headache patients treated with corticosteroids.
A dynamic time warping (DTW) analysis on the data.
Measured: Short daily questionnaire for +- 1 month or +- 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start19 Sep 2022
- Primary completion28 Jul 2024
- Study completion28 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmotionsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik J. Giltay, MD, PhD, Leiden University Medical Center
- Investigators
- Erik Giltay, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391295
- Sponsor's protocol ID
- W2022.002
- Status last verified
- Aug 2026
- First submitted
- 20 May 2022
- Last updated
- 27 Aug 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Emotional Dynamics in Cutaneous T-cell Lymphoma (Type Mycosis Fungoides and/or Sezary Syndrome) Patients and Chronic Cluster Headache Patients During Treatment With Corticosteroids: a Case Series Study
- ClinicalTrials.gov ID
- NCT05391295
- Acronym / sponsor ID
- W2022.002
- Conditions
- Emotions, Corticosteroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 28 Jul 2024 (actual)
- Study completion
- 28 Jul 2024 (actual)
- First posted
- 25 May 2022 (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.
Rationale: Synthetic glucocorticoids can result in neuropsychiatric adverse effects in a minority of patients. Although, not all patients experience severe adverse effects, more subtle emotional disturbances are often experienced. With a variation on ecological momentary assessment (EMA), with a daily assessment, the investigators will collect the patient's emotional symptoms in real time and in the patients natural environment during corticosteroid treatment. With dynamic time warping (DTW) analysis the investigators aim to analyse the temporal dynamics of different emotional states and visualize these emotional dynamics over time. The patient dermatologist and neurologist will receive the idiographic results as a feedback form, which may give insights into temporal (and possibly causal) central emotions, which may help to overcome mood disturbances.
Objective: Mapping emotional dynamics with DTW analysis in 6 mycosis fungoides or Sezary syndrome patients and 6 chronic cluster headache patients treated with systemic corticosteroids.
Study design: Case series report study. Study population: Six patients with cutaneous T-cell lymphoma (type mycosis fungoides and/or Sezary syndrome), and six patients with cluster headache.
Main study parameters/endpoints: An idiographic DTW analysis of emotional dynamics during and after corticosteroid treatment in six mycosis fungoides and/or Sezary syndrome patients, and six chronic cluster headache patients.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no additional risks associated with study participation. The patients who will participate in this case series study need to complete a 5-minute survey daily using a m-Path smartphone app during corticosteroid treatment. The data analysis may increase the insight into centrality measures of emotions and the emotional clusters for the individual patient.
Detailed description
This is a case series study in which we want to map emotional dynamics with DTW analysis in 6 mycosis fungoides and/or Sezary syndrome patients and 10 chronic cluster headache patients, who will be treated with a corticosteroid regime. Duration of the study will approximately be 40-60 days, depending on the duration of the treatment:
- The mycosis fungoides and/or Sezary syndrome patients are treated for approximately 40 days.
- The chronic cluster headache patients are treated for approximately 60 days.
The patient will be treated according to standard regular care. This will not change. For study purposes, a 15 minute explanation of the survey will be given. We will ask the patient to install the m-Path app on their smartphone, and to complete the daily survey (with 23 statements with a slider) on his/her phone during the treatment period, which will take approximately 5 minutes per day. At the end of the study the patient will get the results visualized, with a 30 minute explanation of the results, which may increase insights of the patient's emotions dynamics over time during corticosteroid treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 6 CTCL patients, and 10 chronic cluster headache patients | – | Other: Short daily questionnaireThe patients will be treated according to standard regular care, which is a corticosteroid treatment regime. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mycosis fungoides and/or Sezary syndrome patients and cluster headache patients who will be treated according to standard regular care, which is a corticosteroid treatment regime.
Key inclusion criteria (3 listed)
- Mycosis fungoides and/or Sezary syndrome patients
- Chronic cluster headache patients
- Corticosteroid treatment
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Short daily questionnaireThis study includes 1 survey that needs to be filled out by the patient on his/her phone daily during the course of corticosteroid treatment. The investigators will start the survey few days before the corticosteroid treatment and it will continue till the end of the treatment regime. The treatment regime is regular care and patient specific, but will approximately have a duration of 40 days. In case of prolonged treatment with steroids it is decided to have a limit for our study: either until 7 days after the end of corticosteroid treatment or a maximum of 60 days. | Other | 6 CTCL patients, and 10 chronic cluster headache patients |
Primary outcome
Mapping emotional dynamics with DTW analysis in CTCL patients and cluster headache patients treated with corticosteroids.
Time frame: Short daily questionnaire for +- 1 month or +- 2 months
A dynamic time warping (DTW) analysis on the data.
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 27 Aug 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. This study is not recruiting at the moment.
Erik Giltay, MD, PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emotions and Corticosteroids, run by Leiden University Medical Center at 1 site in Netherlands.
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 3 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: finished, as of the sponsor's last update on 27 Aug 2026. 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 Netherlands. 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?
Mapping emotional dynamics with DTW analysis in CTCL patients and cluster headache patients treated with corticosteroids. (time frame: Short daily questionnaire for +- 1 month or +- 2 months). 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 27 Aug 2026.