Functional Somatic DisorderNCT06301360
Internet Based Emotional Awareness and Expression Therapy for Functional Somatic Disorder With and Without Therapist Support
A study testing Internet based Emotional Awareness and Expression Therapy (I-EAET) in people with Functional Somatic Disorder and Somatic Symptom Disorder, run by Daniel Maroti at 2 sites 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, Functional Somatic Syndromes
- What is being tested?
- Internet based Emotional Awareness and Expression Therapy (I-EAET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Dec 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 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 Adverse Childhood Experience (ACE-10) or reach the proposed cut-off point of 23p 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. benzodiazepines).
- 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
2 sites in 1 country.
Sweden2 sites
Stockholm University
Stockholm, Stockholm County, 10691
Stockholm University
Stockholm, 11419
About this study
Official title: How Much Does the Therapist Matter in Internet Based Emotional Awareness and Expression Therapy (I-EAET) for Functional Somatic Disorder? A Randomised Controlled Trial of I-EAET With and Without Therapist Support
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/functional somatic symptoms (MUS/FSD). 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:
Is internet-based Emotional Awareness and Expression Therapy (I-EAET) with therapist more effective than without therapist support for patients with FSD?
- Being tested
- Internet based Emotional Awareness and Expression Therapy (I-EAET)
- Keywords
- Internet based interventions, EAET, Psychodynamic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet based Emotional Awareness and Expression Therapy (I-EAET)Behavioural
In I-EAET with therapist support, the therapist and participants communicate asynchronous using written messages. The therapist gives feedback each week on home-work assignments and is available on demand for support.
In I-EAET without therapist support, the participants works with home-work assignments on their own and only have technical support.
| Study group | Role | What they receive |
|---|---|---|
| I-EAET with therapist support | Experimental | I-EAET is a 10 week treatment intervention combining principles from emotion focused therapies and neuroscience. Main components include psychoeducation on the body-mind connection, anxiety regulation with self-compassion exercises and different techniques for emotional exposure and processing. Participants have help from a therapist giving feedback. Receives: Behavioral: Internet based Emotional Awareness and Expression Therapy (I-EAET) |
| I-EAET without therapist support | Active comparator | I-EAET is a 10 week treatment intervention combining principles from emotion focused therapies and neuroscience. Main components include psychoeducation on the body-mind connection, anxiety regulation with self-compassion exercises and different techniques for emotional exposure and processing. Participants works on their own and have only technical support. Receives: Behavioral: Internet based Emotional Awareness and Expression Therapy (I-EAET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire -15 (PHQ-15)
Ratings 0-2 on how troublesome somatic symptoms are experienced. Higher scores indicates worse symptom/functioning.
Measured: Change from pre to post treatment (after 10 weeks of treatment)
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 treatment (after 10 weeks of treatment)
Secondary outcomes (6)
Generalized Anxiety Disorder-7 (GAD-7)
Ratings 0-3 on impact of anxiety symptoms. Higher scores indicates worse symptom/functioning.
Measured: Change from pre to post treatment (after 10 weeks of treatment)
Patient Health Questionnaire-9 (PHQ-9)
Ratings 0-3 on impact of depressive symptoms. Higher scores indicates worse symptom/functioning.
Measured: Change from pre to post treatment (after 10 weeks of treatment)
Post traumatic stress disorder checklist-5 (PCL-5)
Ratings 0-4 on impact of post traumatic symptoms. Higher scores indicates worse symptom/functioning.
Measured: Change from pre to post treatment (after 10 weeks of treatment)
Difficulties in Emotion Regulation Scale-16 (DERS-16)
Ratings on emotional (dys)regulation. Higher scores indicates worse symptom/functioning.
Measured: Change from pre to post treatment (after 10 weeks of treatment)
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 treatment (after 10 weeks of treatment)
The revised illness perception questionnaire (IPQ-R)
Ratings on illness beliefs.
Measured: Change from pre to post treatment (after 10 weeks of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Dec 2023
- Primary completion1 Jan 2025
- 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
- Parallel groups
- Model description
- RCT with two treatment arms
- Masking
- None (open label)
- Enrolment
- 150 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301360
- Sponsor's protocol ID
- KOSMOS2 2023-04956-01
- Status last verified
- Jul 2026
- First submitted
- 27 Feb 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Original data shared on demand from other researchers and after approval from Swedish Ethical Review Authority.
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
- How Much Does the Therapist Matter in Internet Based Emotional Awareness and Expression Therapy (I-EAET) for Functional Somatic Disorder? A Randomised Controlled Trial of I-EAET With and Without Therapist Support
- ClinicalTrials.gov ID
- NCT06301360
- Acronym / sponsor ID
- KOSMOS2 2023-04956-01
- Keywords
- Internet based interventions, EAET, Psychodynamic therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Daniel MarotiUniversity, hospital or other
- Collaborators
- Wayne State University
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 8 Mar 2024 (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/functional somatic symptoms (MUS/FSD). 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:
Is internet-based Emotional Awareness and Expression Therapy (I-EAET) with therapist more effective than without therapist support for patients with FSD?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT with two treatment arms
| Arm | Type | Receives |
|---|---|---|
| I-EAET with therapist support | Experimental | Behavioral: Internet based Emotional Awareness and Expression Therapy (I-EAET)I-EAET is a 10 week treatment intervention combining principles from emotion focused therapies and neuroscience. Main components include psychoeducation on the body-mind connection, anxiety regulation with self-compassion exercises and different techniques for emotional exposure and processing. Participants have help from a therapist giving feedback. |
| I-EAET without therapist support | Active comparator | Behavioral: Internet based Emotional Awareness and Expression Therapy (I-EAET)I-EAET is a 10 week treatment intervention combining principles from emotion focused therapies and neuroscience. Main components include psychoeducation on the body-mind connection, anxiety regulation with self-compassion exercises and different techniques for emotional exposure and processing. Participants works on their own and have only technical support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The research subject certifies that he/she has undergone medical assessment for his/her physical symptoms.
- 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 Adverse Childhood Experience (ACE-10) or reach the proposed cut-off point of 23p in the PCL-5).
- Drugs used should have been stable for at least 1 month.
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. benzodiazepines).
- 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 |
|---|---|---|
| Internet based Emotional Awareness and Expression Therapy (I-EAET)In I-EAET with therapist support, the therapist and participants communicate asynchronous using written messages. The therapist gives feedback each week on home-work assignments and is available on demand for support. In I-EAET without therapist support, the participants works with home-work assignments on their own and only have technical support. | Behavioural | I-EAET with therapist support, I-EAET without therapist support |
Primary outcome
Patient Health Questionnaire -15 (PHQ-15)
Time frame: Change from pre to post treatment (after 10 weeks of treatment)
Ratings 0-2 on how troublesome somatic symptoms are experienced. Higher scores indicates worse symptom/functioning.
Numeric Rating Scales according to EURONET-SOMA
Time frame: Change from pre to post treatment (after 10 weeks of treatment)
Visual analogue scale 0-10 for symptom intensity and symptom interference. Higher scores indicates worse symptom/functioning.
6 secondary outcomes
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Change from pre to post treatment (after 10 weeks of treatment)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Change from pre to post treatment (after 10 weeks of treatment)
Post traumatic stress disorder checklist-5 (PCL-5)
Time frame: Change from pre to post treatment (after 10 weeks of treatment)
Difficulties in Emotion Regulation Scale-16 (DERS-16)
Time frame: Change from pre to post treatment (after 10 weeks of treatment)
Sheehan Disability Scale (SDS)
Time frame: Change from pre to post treatment (after 10 weeks of treatment)
The revised illness perception questionnaire (IPQ-R)
Time frame: Change from pre to post treatment (after 10 weeks of treatment)
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.
- Information about study project at Stockholm UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No. Original data shared on demand from other researchers and after approval from Swedish Ethical Review Authority.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet based Emotional Awareness and Expression Therapy (I-EAET) in people with Functional Somatic Disorder and Somatic Symptom Disorder, run by Daniel Maroti at 2 sites 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 5 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 2 sites 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?
Patient Health Questionnaire -15 (PHQ-15) (time frame: Change from pre to post treatment (after 10 weeks of treatment)). 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.