NCT06149182

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

Active, enrolled NA Last updated 17 April 2024

What this trial tests

NA trial testing Life stress interview according to EAET in Functional Somatic Disorder in 189 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

9 October 2023

Primary endpoint
1 June 2024

31 December 2025

Quick facts

Lead sponsor	Daniel Maroti
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	189
Start date	9 October 2023
Primary completion	1 June 2024
Estimated completion	31 December 2025
Sites	1 location across Sweden

Drugs / interventions tested

• Life stress interview according to EAET
• Psychiatric interview according to "region stockholm - basutredning"

Conditions studied

• Functional Somatic Disorder — all drugs for Functional Somatic Disorder →
• Somatic Symptom Disorder — all drugs for Somatic Symptom Disorder →

Sponsor

Daniel Maroti

Who can join

18 and older, any sex, with Functional Somatic Disorder or Somatic Symptom Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 more doctor visits than the general population, but describe themselves as less satisfied with the care they receive. Although Region Stockholm in Sweden recently developed care flows based on 'step up' care for the most common patient groups in primary care, patients with functional or medically unexplained symptoms are not mentioned.

Short-term psychodynamic therapies such as Emotional Awareness and Expression Therapy (EAET) and Intensive Short Term Psychodynamic Therapy (ISTDP) have recently been evaluated in three systematic reviews and show good results for patients with medically unexplained symptoms. Short-term psychodynamic therapy considers that good treatment outcomes for patients with functional somatic syndromes can be achieved by increasing awareness of emotions and teaching patients to better experience, express and regulate emotions. In several randomized studies, short-term psychodynamic therapy has shown good effects even compared to other treatments, including cognitive behavioral therapy (CBT).

The overall purpose of this research project is to to evaluate psychodynamic emotion-focused interventions (EAET and ISTDP) for patients with medically unexplained symptoms and high health care consumption. The project includes several studies that will clarify effects and contribute to information on how care flows in primary care for the patient group can be created.

The research question for this specific study is:

Can a therapeutic interview (so-called "EAET life-stress interview") focusing on emotional factors in comparison to a psychiatric interview (so-called "basic assessment") contribute to increased interest in psychological treatment and reduction of physical and psychiatric symptoms in patients with medically unexplained symptoms with relatively high health care consumption? Does the order of interview interventions matter?

Publications & conference data

No peer-reviewed publications indexed yet for this trial.