Status:

ACTIVE_NOT_RECRUITING

Does the First Interview Matter: A Comparing Life Stress Interview Versus a Standard Psychiatric Intake Interview for Patients With Functional Somatic Disorder

Lead Sponsor:

Daniel Maroti

Collaborating Sponsors:

Wayne State University

Conditions:

Functional Somatic Disorder

Somatic Symptom Disorder

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Functional somatic syndromes (e.g. irritable bowel syndrome, fibromyalgia) and medically unexplained symptoms (e.g. chronic primary pain) are very common in primary care. These patients make 14 times ...

Eligibility Criteria

Inclusion

  • The research subject certifies that he/she has undergone medical assessment for his/her physical symptoms.
  • The subject must have visited a physician at least three times in the last year.
  • 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 ACE-10 or reach the proposed cut-off point of 21p in the PCL-5).
  • Drugs used should have been stable for at least 1 month.

Exclusion

  • 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. benzodiazipines).
  • 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.

Key Trial Info

Start Date :

October 9 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2025

Estimated Enrollment :

189 Patients enrolled

Trial Details

Trial ID

NCT06149182

Start Date

October 9 2023

End Date

December 31 2025

Last Update

April 17 2024

Active Locations (1)

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1

Stockholm University

Stockholm, Sweden, 10691