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:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT06301360
Eligibility Criteria:
Inclusion Criteria:
* The research subject certifies that he/she has undergone medical assessment for his/her physical symptoms.
* The subject rates either moderate distress from bodily symptoms in the PHQ-15 (over 10 points) or severe distress from a single bodily symptom (at least 2 points for this symptom).
* The research participants expresses interest in investigating whether emotional factors such as stress may contribute to symptoms.
* Research subjects either affirm the presence of emotionally difficult life events (affirm at least 1 such event in the Adverse Childhood Experience (ACE-10) or reach the proposed cut-off point of 23p in the PCL-5).
* Drugs used should have been stable for at least 1 month.
Exclusion Criteria:
* Research subjects suffer from ongoing substance abuse (alcohol or drugs) or are deemed to have serious mental illness (psychotic illness, suicidal ideation, antisocial personality disorder etc).
* The research subjects have ongoing medication of a clearly addictive and sedative nature (e.g. benzodiazepines).
* The research subject participates in other psychological treatment focusing on physical symptoms. However, other psychological treatment is allowed where the support therapy does not take place more often than once a month.
* The research subject does not master the Swedish language sufficiently to be able to assimilate written material in Swedish.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06301360
Study Brief:
Protocol Section:
NCT06301360