Functional Somatic DisorderNCT06149182
Does the First Interview Matter: A Comparing Life Stress Interview Versus a Standard Psychiatric Intake Interview for Patients With Functional Somatic Disorder
A study testing Life stress interview according to EAET and Psychiatric interview according to "region stockholm - basutredning" in people with Functional Somatic Disorder and Somatic Symptom Disorder, run by Daniel Maroti at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Somatic Disorder, Somatic Symptom Disorder
- What is being tested?
- Life stress interview according to EAET and Psychiatric interview according to "region stockholm - basutredning"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteSweden
- Study dates
- 9 Oct 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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?
- Being tested
- Life stress interview according to EAET, Psychiatric interview according to "region stockholm - basutredning"
- Keywords
- Functional somatic disorder, Somatic symptom disorder, life stress interview, emotional awareness and expression therapy, intensive short term psychodynamic therapy, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life stress interview according to EAETBehavioural
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"Behavioural
This interview has the aim to gain enough information to diagnose some of the main psychiatric disorders
| Study group | Role | What they receive |
|---|---|---|
| Life stress interview/therapeutic interview | Experimental | Revised "Life stress interview" according to protocol from emotional awareness and expression therapy Receives: Behavioral: Life stress interview according to EAET |
| Psychiatric interview | Active comparator | Psychiatric interview (M.I.N.I. etc) according to "Region stockholm - basutredning" Receives: Behavioral: Psychiatric interview according to "region stockholm - basutredning" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scales according to EURONET-SOMA
Visual analogue scale 0-10 for symptom intensity and symptom interference. Higher scores indicates worse symptom/functioning.
Measured: Change from pre to follow up (6 weeks after interview)
PHQ-15
Ratings 0-2 on how troublesome somatic symptoms are experienced. Higher scores indicates worse symptom/functioning.
Measured: Change from pre to follow up (6 weeks after interview)
Secondary outcomes (8)
Numeric Rating Scales according to EURONET-SOMA
Visual analogue scale 0-10 for symptom intensity and symptom interference. Higher scores indicates worse symptom/functioning.
Measured: Change from pre to post (within 1 week after interview)
PHQ-15
Ratings 0-2 on how troublesome somatic symptoms are experienced. Higher scores indicates worse symptom/functioning.
Measured: Change from pre to post (within 1 week after interview)
PHQ-9
Ratings 0-3 on impact of depressive symptoms. Higher scores indicates worse symptom/functioning.
Measured: Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
GAD-7
Ratings 0-3 on impact of anxiety symptoms.Higher scores indicates worse symptom/functioning.
Measured: Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
PCL-5
Ratings 0-4 on impact of post traumatic symptoms. Higher scores indicates worse symptom/functioning.
Measured: Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
DERS-16
Ratings on emotional (dys)regulation. Higher scores indicates worse symptom/functioning.
Measured: Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
Sheehan Disability Scale (SDS)
Visual analogue scale 0-10 for symptom interference in daily life. Higher scores indicates worse symptom/functioning.
Measured: Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
IPQ-R
Ratings on illness beliefs.
Measured: Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start9 Oct 2023
- Primary completion1 Jun 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Somatic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Maroti
- Sponsor type
- University, hospital or other
- Collaborators
- Wayne State University
- Responsible party
- Sponsor-investigator, Daniel Maroti, Stockholm University
- Investigators
- Peter Lilliengren, PhD, Principal investigator, Stockholm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149182
- Sponsor's protocol ID
- StockholmU
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2023
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06149182
- Acronym / sponsor ID
- StockholmU
- Keywords
- Functional somatic disorder, Somatic symptom disorder, life stress interview, emotional awareness and expression therapy, intensive short term psychodynamic therapy, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Daniel MarotiUniversity, hospital or other
- Collaborators
- Wayne State University
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Life stress interview/therapeutic interview | Experimental | Behavioral: Life stress interview according to EAETRevised "Life stress interview" according to protocol from emotional awareness and expression therapy |
| Psychiatric interview | Active comparator | Behavioral: Psychiatric interview according to "region stockholm - basutredning"Psychiatric interview (M.I.N.I. etc) according to "Region stockholm - basutredning" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life stress interview according to EAETThis 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. | Behavioural | Life stress interview/therapeutic interview |
| Psychiatric interview according to "region stockholm - basutredning"This interview has the aim to gain enough information to diagnose some of the main psychiatric disorders | Behavioural | Psychiatric interview |
Primary outcome
Numeric Rating Scales according to EURONET-SOMA
Time frame: Change from pre to follow up (6 weeks after interview)
Visual analogue scale 0-10 for symptom intensity and symptom interference. Higher scores indicates worse symptom/functioning.
PHQ-15
Time frame: Change from pre to follow up (6 weeks after interview)
Ratings 0-2 on how troublesome somatic symptoms are experienced. Higher scores indicates worse symptom/functioning.
8 secondary outcomes
Numeric Rating Scales according to EURONET-SOMA
Time frame: Change from pre to post (within 1 week after interview)
PHQ-15
Time frame: Change from pre to post (within 1 week after interview)
PHQ-9
Time frame: Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
GAD-7
Time frame: Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
PCL-5
Time frame: Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
DERS-16
Time frame: Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
Sheehan Disability Scale (SDS)
Time frame: Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
IPQ-R
Time frame: Change from pre to post (within 1 week after interview) and follow up (6 weeks after interview)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Lilliengren, PhD principal investigator
Stockholm University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life stress interview according to EAET and Psychiatric interview according to "region stockholm - basutredning" in people with Functional Somatic Disorder and Somatic Symptom Disorder, run by Daniel Maroti at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scales according to EURONET-SOMA (time frame: Change from pre to follow up (6 weeks after interview)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.