Emotions Clinical Trial
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
NCT number | NCT05391295 |
Other study ID # | W2022.002 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 19, 2022 |
Est. completion date | March 2025 |
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.
Status | Recruiting |
Enrollment | 12 |
Est. completion date | March 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Mycosis fungoides and/or Sezary syndrome patients - Chronic cluster headache patients - Corticosteroid treatment Exclusion Criteria: - N/A |
Country | Name | City | State |
---|---|---|---|
Netherlands | LUMC | Leiden | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Short daily questionnaire for +- 1 month or +- 2 months |
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