Mapping Emotional Dynamics During Corticosteroid Treatment

NCT05391295 | Recruiting

• 1 other identifier: W2022.002
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotions; Corticosteroids

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

6 CTCL patients, and 6 chronic cluster headache patients

The patients will be treated according to standard regular care, which is a corticosteroid treatment regime.

Other: Short daily questionnaire

Interventions

Short daily questionnaire OTHER

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.

6 CTCL patients, and 6 chronic cluster headache patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

LUMC

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

Study Officials

• Erik Giltay, MD, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulien van Tilborg, MSc

CONTACT

0031 71 5263448; P.J.van_Tilborg@lumc.nl

Erik Giltay, MD, PhD

CONTACT

0031 71 5263448; e.j.giltay@lumc.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: September 19, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

NL (1)