Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-24 @ 9:55 PM
NCT ID:
NCT07058532
Eligibility Criteria:
Inclusion Criteria:
* Adult women (18 years or older), assigned female at birth and self-identify as women
* Diagnosed with or experience of chronic, widespread (non-cancer) pain lasting at least two years
* Diagnosed with or living with one or more mild mental health disorders (e.g., anxiety, mild depression), without current or past severe psychiatric conditions
* Diagnosed with or experience of nociplastic pain (e.g., fibromyalgia)
* Not currently using medications that may impair cognitive functioning (e.g., benzodiazepines, anticholinergics, opioids, antipsychotics)
* Able to attend approximately 11 in-person visits over a 3-month period
* Willing and able to participate in a structured therapeutic writing intervention
* Purposefully selected to reflect a range of lived experiences relevant to the study's aims
Exclusion Criteria:
* Presence of severe mental health disorders (e.g., schizophrenia, bipolar disorder, severe depression, or other psychotic conditions)
* Use of medications known to impair memory, attention, or decision-making (e.g., benzodiazepines, anticholinergics, opioids, antipsychotics)
* Participation in other concurrent treatments that may influence study outcomes
* Cognitive limitations that would hinder meaningful engagement in the writing intervention
* Individuals not assigned female at birth or who do not identify as women
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07058532
Study Brief:
Protocol Section:
NCT07058532