Clinical trial NCT06149182: Does the First Interview Matter: A Comparing Life Stress Interview Versus a Standard Psychiatric Intake Interview for Patients With Functional Somatic Disorder
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Functional Somatic Disorder
Somatic Symptom Disorder
Keywords: Functional somatic disorder
Somatic symptom disorder
life stress interview
emotional awareness and expression therapy
intensive short term psychodynamic therapy
randomized controlled trial
Lead sponsor: Stockholm University
Sponsor class: OTHER
Collaborators: name: Wayne State University
First posted: 2023-11-28
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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?


Eligibility criteria: 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.

Primary outcomes:
measure: Numeric Rating Scales according to EURONET-SOMA
timeFrame: Change from pre to follow up (6 weeks after interview)
measure: PHQ-15
timeFrame: Change from pre to follow up (6 weeks after interview)
Secondary outcomes:
measure: Numeric Rating Scales according to EURONET-SOMA
timeFrame: Change from pre to post (within 1 week after interview)
measure: PHQ-15
timeFrame: Change from pre to post (within 1 week after interview)
measure: PHQ-9
timeFrame: Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
measure: GAD-7
timeFrame: Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
measure: PCL-5
timeFrame: Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
measure: DERS-16
timeFrame: Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
measure: Sheehan Disability Scale (SDS)
timeFrame: Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
measure: IPQ-R
timeFrame: Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholm University
Study officials:
affiliation: Stockholm University
name: Peter Lilliengren, PhD
role: PRINCIPAL_INVESTIGATOR
References: