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Mapping Emotional Dynamics During Corticosteroid Treatment

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05391295
Enrollment
15
Registered
2022-05-25
Start date
2022-09-19
Completion date
2024-07-28
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corticosteroids, Emotions

Brief 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. 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.

Interventions

OTHERShort daily questionnaire

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.

Sponsors

Leiden University Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Mycosis fungoides and/or Sezary syndrome patients * Chronic cluster headache patients * Corticosteroid treatment

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
Mapping emotional dynamics with DTW analysis in CTCL patients and cluster headache patients treated with corticosteroids.Short daily questionnaire for +- 1 month or +- 2 monthsA dynamic time warping (DTW) analysis on the data.

Countries

Netherlands

Contacts

PRINCIPAL_INVESTIGATORErik Giltay, MD, PhD

Leiden University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026