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

Somatic Symptom Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06149182
• Other study ID #: StockholmU
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 9, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Stockholm University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 189
• Est. completion date: December 31, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The research subject certifies that he/she has undergone medical assessment for his/her physical symptoms.

2. The subject must have visited a physician at least three times in the last year.

3. 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).

4. The research participants expresses interest in investigating whether emotional factors such as stress may contribute to symptoms.

5. 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).

6. Drugs used should have been stable for at least 1 month.

Exclusion Criteria:

1. 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).

2. The research subjects have ongoing medication of a clearly addictive and sedative nature (e.g. benzodiazipines).

3. 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.

4. The research subject does not master the Swedish language sufficiently to be able to assimilate written material in Swedish.

Related Conditions & MeSH terms

• Medically Unexplained Symptoms
• Somatic Symptom Disorder
• Stress, Psychological

Intervention

Behavioral:
• Life stress interview according to EAET
This interview has the aim to jointly explore potential emotional factors contributing to patients functional somatic symptoms. While exploring this, it has the aim to not only describe such potential patterns but also emotionally process them.
• Psychiatric interview according to "region stockholm - basutredning"
This interview has the aim to gain enough information to diagnose some of the main psychiatric disorders

Locations

Country	Name	City	State
Sweden	Stockholm University	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Daniel Maroti	Wayne State University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Rating Scales according to EURONET-SOMA	Visual analogue scale 0-10 for symptom intensity and symptom interference. Higher scores indicates worse symptom/functioning.	Change from pre to follow up (6 weeks after interview)
Primary	PHQ-15	Ratings 0-2 on how troublesome somatic symptoms are experienced. Higher scores indicates worse symptom/functioning.	Change from pre to follow up (6 weeks after interview)
Secondary	Numeric Rating Scales according to EURONET-SOMA	Visual analogue scale 0-10 for symptom intensity and symptom interference. Higher scores indicates worse symptom/functioning.	Change from pre to post (within 1 week after interview)
Secondary	PHQ-15	Ratings 0-2 on how troublesome somatic symptoms are experienced. Higher scores indicates worse symptom/functioning.	Change from pre to post (within 1 week after interview)
Secondary	PHQ-9	Ratings 0-3 on impact of depressive symptoms. Higher scores indicates worse symptom/functioning.	Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
Secondary	GAD-7	Ratings 0-3 on impact of anxiety symptoms.Higher scores indicates worse symptom/functioning.	Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
Secondary	PCL-5	Ratings 0-4 on impact of post traumatic symptoms. Higher scores indicates worse symptom/functioning.	Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
Secondary	DERS-16	Ratings on emotional (dys)regulation. Higher scores indicates worse symptom/functioning.	Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
Secondary	Sheehan Disability Scale (SDS)	Visual analogue scale 0-10 for symptom interference in daily life. Higher scores indicates worse symptom/functioning.	Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
Secondary	IPQ-R	Ratings on illness beliefs.	Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)