Somatic Symptom and Related DisordersNCT06631963
Telehealth Group-based Emotional Awareness and Expression Therapy for Patients With Persistent Physical Symptoms: A Pilot Study
A study testing Emotional Awareness and Expression Therapy in people with Somatic Symptom and Related Disorders and Somatic Symptom Disorder, run by Daniel Maroti at 1 site in Sweden.
Trial summary
Delivering Emotional Awareness and Expression Therapy (EAET) through digital or telehealth platforms in a group format offers several key advantages. First, it significantly improves access to care, allowing individuals with persistent physical symptoms (PPS) to receive effective, emotion-focused therapy regardless of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Somatic Symptom and Related Disorders, Somatic Symptom Disorder, Functional Somatic Disorder
- What is being tested?
- Emotional Awareness and Expression Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2025to 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 participant certifies that he or she has undergone a medical evaluation for their physical symptoms (see separate certificate).
- The participant rates either moderate distress from physical symptoms on the PHQ-15 form (over 10 points) or significant distress from a single physical symptom (at least 2 points for that symptom).
- The participant expresses interest in exploring whether emotional factors, such as stress, may contribute to their symptom profile.
- Any prescribed medications must have been stable for at least 1 month.
Who cannot join
- Participants suffer from ongoing substance abuse (alcohol or drugs) or are assessed to have severe mental health issues (psychotic disorders, moderate to high suicide risk, antisocial personality disorder, etc.).
- Participants are currently prescribed medications that are clearly addictive and sedative in nature (e.g., benzodiazepines).
- Participants are involved in other psychological treatments focused on physical symptoms. However, other psychological treatments are allowed as long as the supportive therapy does not occur more than once a month.
- Participants do not have sufficient proficiency in the Swedish language.
Trial locations and contacts
1 site in 1 country.
About this study
Delivering Emotional Awareness and Expression Therapy (EAET) through digital or telehealth platforms in a group format offers several key advantages. First, it significantly improves access to care, allowing individuals with persistent physical symptoms (PPS) to receive effective, emotion-focused therapy regardless of their geographic location. Telehealth can also benefit those who face mobility issues or have limited access to specialized care in rural or underserved areas.
Group-based telehealth EAET promotes social connection among participants, fostering a supportive environment where individuals can share experiences, which may enhance therapeutic outcomes. Additionally, the convenience of remote therapy can reduce barriers to participation, such as time constraints and travel costs, making it easier for patients to commit to treatment.
Finally, the digital format allows for flexible, scalable interventions that can be easily integrated into routine psychiatric care, potentially increasing treatment uptake for individuals who might otherwise avoid in-person therapy due to stigma or logistical challenges.
- Conditions
- Somatic Symptom and Related Disorders, Somatic Symptom Disorder, Functional Somatic Disorder, Functional Somatic Syndrome
- Being tested
- Emotional Awareness and Expression Therapy
- Medical subject headings
- Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Awareness and Expression TherapyBehavioural
Emotional Awareness and Expression Therapy (EAET) is a form of psychotherapy designed to help individuals identify, process, and express emotions that may be linked to physical symptoms or chronic pain. It emphasizes the role of unresolved emotional experiences, such as trauma or interpersonal conflicts, in contributing to physical distress. Through EAET, patients learn to connect their emotions to their physical symptoms, express those emotions in a healthier way, and ultimately reduce both emotional and physical suffering. This therapy has been shown to be effective in treating conditions such as chronic pain, irritable bowel syndrome, and fibromyalgia.
| Study group | Role | What they receive |
|---|---|---|
| Group EAET delivered through telehealth | Other | Group-based Emotional Awareness and Expression Therapy (EAET) delivered through telehealth is a form of psychotherapy that helps individuals recognize and express emotions that may be contributing to physical symptoms. It is conducted in a group setting, allowing participants to share their experiences and support each other. Through a virtual platform, patients engage in structured sessions led by a therapist, where they explore emotional connections to their symptoms, practice emotional expression, and develop healthier coping mechanisms. The telehealth format enables access to therapy from remote locations, enhancing convenience and flexibility while maintaining the benefits of group interaction. Receives: Behavioral: Emotional Awareness and Expression Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionaire-15 (PHQ-15)
Somatic symptom severity during the "last week" was assessed with the PHQ-15. Items were rated 0 ("Not bothered at all"), 1 ("Bothered a little"), or 2 ("Bothered a lot"); total scores range from 0 to 30 for women and 0-27 for men.
Measured: Change from pre to post treatment (i.e pre-treatment ca. 1 week before treatment. Post-treatment ca 1 week after treatment ends at 12 weeks.)
Visual Analoge Scales
Visual Analoge Scales suggested by the EURONET-SOMA network (Rief et al., 2017). Somatic symptom intensity was measured from 1 ("No symptom") to 10 ("Symptom as bad as you can imagine") and somatic symptom interference from 1 ("No interference") to 10 ("Maximum interference").
Measured: Change from pre to post treatment (i.e pre-treatment ca. 1 week before treatment. Post-treatment ca 1 week after treatment ends at 12 weeks.)
Secondary outcomes (3)
Patient Health Questionaire-9 (PHQ-9)
PHQ-9 consists of nine questions withs ratings 0-3 (0= "not at all", 3= "almost every day") on impact of depressive symptoms. Higher scores indicate worse symptom/functioning with a maximum score of 27.
Measured: Change from pre to post treatment (i.e pre-treatment ca. 1 week before treatment. Post-treatment ca 1 week after treatment ends at 12 weeks.)
Generalized Anxiety Disorder 7-item scale (GAD-7)
GAD-7 consists of seven questions with ratings 0-3 (0= "not at all", 3= "almost every day") on impact of anxiety symptoms. Higher scores indicate worse symptom/functioning functioning with a maximum score of 21.
Measured: Change from pre to post treatment (i.e pre-treatment ca. 1 week before treatment. Post-treatment ca 1 week after treatment ends at 12 weeks.)
Post traumatic symptom Check List-5 (PCL-5)
PCL-5 consists of 20 questions with ratings 0-4 on impact of post traumatic symptoms. Higher scores indicate worse symptom/functioning with a maximum score of 80.
Measured: Change from pre to post treatment (i.e pre-treatment ca. 1 week before treatment. Post-treatment ca 1 week after treatment ends at 12 weeks.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Jan 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Why it stopped: To few resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatic Symptom and Related DisordersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Maroti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Maroti, Stockholm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631963
- Sponsor's protocol ID
- KOSMOS3-Grupp
- Status last verified
- Jul 2026
- First submitted
- 1 Oct 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: Participants has not approved this.
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
- Telehealth Group-based Emotional Awareness and Expression Therapy for Patients With Persistent Physical Symptoms: A Pilot Study
- ClinicalTrials.gov ID
- NCT06631963
- Acronym / sponsor ID
- KOSMOS3-Grupp
- Conditions
- Somatic Symptom and Related Disorders, Somatic Symptom Disorder, Functional Somatic Disorder, Functional Somatic Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: To few resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Daniel MarotiUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 8 Oct 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.
Delivering Emotional Awareness and Expression Therapy (EAET) through digital or telehealth platforms in a group format offers several key advantages. First, it significantly improves access to care, allowing individuals with persistent physical symptoms (PPS) to receive effective, emotion-focused therapy regardless of their geographic location. Telehealth can also benefit those who face mobility issues or have limited access to specialized care in rural or underserved areas.
Group-based telehealth EAET promotes social connection among participants, fostering a supportive environment where individuals can share experiences, which may enhance therapeutic outcomes. Additionally, the convenience of remote therapy can reduce barriers to participation, such as time constraints and travel costs, making it easier for patients to commit to treatment.
Finally, the digital format allows for flexible, scalable interventions that can be easily integrated into routine psychiatric care, potentially increasing treatment uptake for individuals who might otherwise avoid in-person therapy due to stigma or logistical challenges.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group EAET delivered through telehealth | Other | Behavioral: Emotional Awareness and Expression TherapyGroup-based Emotional Awareness and Expression Therapy (EAET) delivered through telehealth is a form of psychotherapy that helps individuals recognize and express emotions that may be contributing to physical symptoms. It is conducted in a group setting, allowing participants to share their experiences and support each other. Through a virtual platform, patients engage in structured sessions led by a therapist, where they explore emotional connections to their symptoms, practice emotional expression, and develop healthier coping mechanisms. The telehealth format enables access to therapy from remote locations, enhancing convenience and flexibility while maintaining the benefits of group interaction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The participant certifies that he or she has undergone a medical evaluation for their physical symptoms (see separate certificate).
- The participant rates either moderate distress from physical symptoms on the PHQ-15 form (over 10 points) or significant distress from a single physical symptom (at least 2 points for that symptom).
- The participant expresses interest in exploring whether emotional factors, such as stress, may contribute to their symptom profile.
- Any prescribed medications must have been stable for at least 1 month.
Key exclusion criteria (4 listed)
- Participants suffer from ongoing substance abuse (alcohol or drugs) or are assessed to have severe mental health issues (psychotic disorders, moderate to high suicide risk, antisocial personality disorder, etc.).
- Participants are currently prescribed medications that are clearly addictive and sedative in nature (e.g., benzodiazepines).
- Participants are involved in other psychological treatments focused on physical symptoms. However, other psychological treatments are allowed as long as the supportive therapy does not occur more than once a month.
- Participants do not have sufficient proficiency in the Swedish language.
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 |
|---|---|---|
| Emotional Awareness and Expression TherapyEmotional Awareness and Expression Therapy (EAET) is a form of psychotherapy designed to help individuals identify, process, and express emotions that may be linked to physical symptoms or chronic pain. It emphasizes the role of unresolved emotional experiences, such as trauma or interpersonal conflicts, in contributing to physical distress. Through EAET, patients learn to connect their emotions to their physical symptoms, express those emotions in a healthier way, and ultimately reduce both emotional and physical suffering. This therapy has been shown to be effective in treating conditions such as chronic pain, irritable bowel syndrome, and fibromyalgia. | Behavioural | Group EAET delivered through telehealth |
Primary outcome
Patient Health Questionaire-15 (PHQ-15)
Time frame: Change from pre to post treatment (i.e pre-treatment ca. 1 week before treatment. Post-treatment ca 1 week after treatment ends at 12 weeks.)
Somatic symptom severity during the "last week" was assessed with the PHQ-15. Items were rated 0 ("Not bothered at all"), 1 ("Bothered a little"), or 2 ("Bothered a lot"); total scores range from 0 to 30 for women and 0-27 for men.
Visual Analoge Scales
Time frame: Change from pre to post treatment (i.e pre-treatment ca. 1 week before treatment. Post-treatment ca 1 week after treatment ends at 12 weeks.)
Visual Analoge Scales suggested by the EURONET-SOMA network (Rief et al., 2017). Somatic symptom intensity was measured from 1 ("No symptom") to 10 ("Symptom as bad as you can imagine") and somatic symptom interference from 1 ("No interference") to 10 ("Maximum interference").
3 secondary outcomes
Patient Health Questionaire-9 (PHQ-9)
Time frame: Change from pre to post treatment (i.e pre-treatment ca. 1 week before treatment. Post-treatment ca 1 week after treatment ends at 12 weeks.)
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: Change from pre to post treatment (i.e pre-treatment ca. 1 week before treatment. Post-treatment ca 1 week after treatment ends at 12 weeks.)
Post traumatic symptom Check List-5 (PCL-5)
Time frame: Change from pre to post treatment (i.e pre-treatment ca. 1 week before treatment. Post-treatment ca 1 week after treatment ends at 12 weeks.)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No. Participants has not approved this.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Awareness and Expression Therapy in people with Somatic Symptom and Related Disorders 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 4 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: withdrawn, 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 was withdrawn before enrolling participants, so there are no results.
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 Questionaire-15 (PHQ-15) (time frame: Change from pre to post treatment (i.e pre-treatment ca. 1 week before treatment. Post-treatment ca 1 week after treatment ends at 12 weeks.)). 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.