Persistent Physical Symptoms (PPS)EAET for PPSNCT06631911
Emotional Awareness and Expression Therapy for Patients With Persistent Physical Symptoms in Routine Psychiatric Care: A Pilot Study
A study testing Emotional Awareness and Expression Therapy (EAET) in people with Persistent Physical Symptoms (PPS) and Functional Somatic Disorder, run by Daniel Maroti at 1 site in Sweden.
Trial summary
Emotional Awareness and Expression Therapy (EAET) has emerged as a promising approach for addressing persistent physical symptoms (PPS). Investigating EAET within the context of routine psychiatric care is crucial for several reasons: Many patients with PPS experience significant distress and functional impairment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Physical Symptoms (PPS), Functional Somatic Disorder, Functional Somatic Syndromes
- What is being tested?
- Emotional Awareness and Expression Therapy (EAET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2024to 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 they have undergone a medical assessment for their physical symptoms (see separate certificate).
- The participant rates either moderate distress from physical symptoms on the PHQ-15 questionnaire (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 one 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 permitted as long as the supportive therapy does not occur more than once a month.
- Participants do not have sufficient proficiency in the Swedish language.
- Please note that it is the chief physician of each respective research sponsor who, based on collected anamnesis and self-assessment information, makes the final decision regarding whether a participant should be included or excluded from the research project.
Trial locations and contacts
1 site in 1 country.
About this study
Emotional Awareness and Expression Therapy (EAET) has emerged as a promising approach for addressing persistent physical symptoms (PPS). Investigating EAET within the context of routine psychiatric care is crucial for several reasons:
Many patients with PPS experience significant distress and functional impairment, yet traditional medical treatments often fail to provide adequate relief. Integrating EAET into routine care could offer a valuable therapeutic option for this population.
Read more
Preliminary studies suggest that EAET can lead to significant reductions in pain and other somatic symptoms. Investigating its effectiveness in routine care settings could enhance treatment outcomes for patients who have not responded to conventional therapies.
There is often a disconnect between mental health and physical health treatment in routine care. Investigating EAET can help bridge this gap, fostering collaboration between mental health professionals and primary care providers to address the complexities of patients\' health issues.
- Conditions
- Persistent Physical Symptoms (PPS), Functional Somatic Disorder, Functional Somatic Syndromes, Somatic Symptom Disorder (DSM-5)
- Being tested
- Emotional Awareness and Expression Therapy (EAET)
- Keywords
- Emotional Awareness and Expression Therapy, Group psychotherapy, routine care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Awareness and Expression Therapy (EAET)Behavioural
Emotional Awareness and Expression Therapy (EAET) is a manualized, short-term psychodynamic therapy that, in this instance, is delivered in a group format.
The core of Emotional Awareness and Expression Therapy (EAET) involves helping individuals identify, understand, and express their emotions in a therapeutic setting. The therapy emphasizes the connection between unprocessed emotions and physical symptoms, encouraging participants to explore the emotional underpinnings of their distress. Through guided discussions, psychoeducation, and expressive exercises, participants learn to recognize patterns of emotional avoidance, develop self-compassion, and improve interpersonal communication. This process aims to reduce somatic symptoms and enhance overall emotional well-being by fostering a greater awareness of emotional experiences.
| Study group | Role | What they receive |
|---|---|---|
| Emotional Awareness and Expression Therapy | Other | Please see description for intervention Receives: Behavioral: Emotional Awareness and Expression Therapy (EAET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-15 (PHQ-15)
Somatic symptom severity during the "last week " are assessed with the Patient Health Questionnaire-15 (PHQ-15). Items are rated 0 ("not bothered at all"), 1 ("bothered a little"), or 2 ("bothered a lot"); total scores range from 0 to 30.
Measured: Pre-post treatment (at treatment termination)
Visual Analoge Scales
A second primary outcome is the two Visual Analoge Scales suggested by the EURONET-SOMA network (Rief et al., 2017). Somatic symptom intensity is 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: Pre-post treatment (at treatment termination)
Secondary outcomes (6)
Sheehan Disability Scale
SDS consist on three visual analogue scales ranging from 0-10 for symptom interference in daily life. Higher scores indicate worse symptom/functioning, with a maximum score of 30.
Measured: 1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
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: 1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
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: 1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
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: 1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
Visual Analoge Scales
Visual Analoge Scales suggested by the EURONET-SOMA network (Rief et al., 2017). Somatic symptom intensity is 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: Pre-FU (12 weeks after intervention)
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: Pre-FU (12 weeks after intervention)
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 Nov 2024
- 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 Persistent Physical Symptoms (PPS)Studies 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
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Maroti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Maroti, Stockholm University
- Investigators
- Daniel Maroti, PhD, Principal investigator, Department of Psychology, Faculty of Social Sciences, Stockholm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631911
- Sponsor's protocol ID
- EAET for PPS: a pilot study
- Other IDs
- 5631, 1111
- Acronym
- EAET for PPS
- 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: The participants has not agreed to 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
- Emotional Awareness and Expression Therapy for Patients With Persistent Physical Symptoms in Routine Psychiatric Care: A Pilot Study
- ClinicalTrials.gov ID
- NCT06631911
- Acronym / sponsor ID
- EAET for PPS / EAET for PPS: a pilot study
- Conditions
- Persistent Physical Symptoms (PPS), Functional Somatic Disorder, Functional Somatic Syndromes, Somatic Symptom Disorder (DSM-5)
- Keywords
- Emotional Awareness and Expression Therapy, Group psychotherapy, routine care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: To few resources
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Daniel MarotiUniversity, hospital or other
- Study start
- 1 Nov 2024 (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.
Emotional Awareness and Expression Therapy (EAET) has emerged as a promising approach for addressing persistent physical symptoms (PPS). Investigating EAET within the context of routine psychiatric care is crucial for several reasons:
Many patients with PPS experience significant distress and functional impairment, yet traditional medical treatments often fail to provide adequate relief. Integrating EAET into routine care could offer a valuable therapeutic option for this population.
Preliminary studies suggest that EAET can lead to significant reductions in pain and other somatic symptoms. Investigating its effectiveness in routine care settings could enhance treatment outcomes for patients who have not responded to conventional therapies.
There is often a disconnect between mental health and physical health treatment in routine care. Investigating EAET can help bridge this gap, fostering collaboration between mental health professionals and primary care providers to address the complexities of patients\' health issues.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Emotional Awareness and Expression Therapy | Other | Behavioral: Emotional Awareness and Expression Therapy (EAET)Please see description for intervention |
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 they have undergone a medical assessment for their physical symptoms (see separate certificate).
- The participant rates either moderate distress from physical symptoms on the PHQ-15 questionnaire (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 one month.
Key exclusion criteria (5 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 permitted as long as the supportive therapy does not occur more than once a month.
- Participants do not have sufficient proficiency in the Swedish language.
- Please note that it is the chief physician of each respective research sponsor who, based on collected anamnesis and self-assessment information, makes the final decision regarding whether a participant should be included or excluded from the research project.
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 Therapy (EAET)Emotional Awareness and Expression Therapy (EAET) is a manualized, short-term psychodynamic therapy that, in this instance, is delivered in a group format. The core of Emotional Awareness and Expression Therapy (EAET) involves helping individuals identify, understand, and express their emotions in a therapeutic setting. The therapy emphasizes the connection between unprocessed emotions and physical symptoms, encouraging participants to explore the emotional underpinnings of their distress. Through guided discussions, psychoeducation, and expressive exercises, participants learn to recognize patterns of emotional avoidance, develop self-compassion, and improve interpersonal communication. This process aims to reduce somatic symptoms and enhance overall emotional well-being by fostering a greater awareness of emotional experiences. | Behavioural | Emotional Awareness and Expression Therapy |
Primary outcome
Patient Health Questionnaire-15 (PHQ-15)
Time frame: Pre-post treatment (at treatment termination)
Somatic symptom severity during the "last week " are assessed with the Patient Health Questionnaire-15 (PHQ-15). Items are rated 0 ("not bothered at all"), 1 ("bothered a little"), or 2 ("bothered a lot"); total scores range from 0 to 30.
Visual Analoge Scales
Time frame: Pre-post treatment (at treatment termination)
A second primary outcome is the two Visual Analoge Scales suggested by the EURONET-SOMA network (Rief et al., 2017). Somatic symptom intensity is 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").
6 secondary outcomes
Sheehan Disability Scale
Time frame: 1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
Post traumatic symptom Check List-5 (PCL-5),
Time frame: 1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
Patient Health Questionaire-9 (PHQ-9)
Time frame: 1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: 1. Pre-post treatment (at treatment termination). 2. Pre-Follow up (12 weeks after intervention).
Visual Analoge Scales
Time frame: Pre-FU (12 weeks after intervention)
Patient Health Questionaire-15 (PHQ-15)
Time frame: Pre-FU (12 weeks after intervention)
Results and safety
The study was stopped early (reason given: To few resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No. The participants has not agreed to this
Related trials for Persistent Physical Symptoms (PPS)
Recruiting
My Symptoms Young - a New Internet-based Programme for Young People With Persistent Physical Symptoms in Primary Care: Exploration of Effect and Health Literacy Characteristics Among Users
Persistent Physical Symptoms (PPS), Bodily Distress Syndrome
Active, not recruitingObservational study
The Pilot of the Turku Outpatient Clinic for Functional and Fatigue Disorders
Persistent Physical Symptoms (PPS), Functional Disorder
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.
Daniel Maroti, PhD principal investigator
Department of Psychology, Faculty of Social Sciences, 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 Emotional Awareness and Expression Therapy (EAET) in people with Persistent Physical Symptoms (PPS) and Functional Somatic 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 5 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: stopped early, 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 stopped early (reason given: To few resources). Results are not available in the source record.
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: Pre-post treatment (at treatment termination)). 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.