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WithdrawnNCT06631963Updated Jul 27, 2026

Telehealth Group-based Emotional Awareness and Expression Therapy for Patients With Persistent Physical Symptoms: A Pilot Study

An interventional study of Emotional Awareness and Expression Therapy in Somatic Symptom and Related Disorders, Somatic Symptom Disorder and Functional Somatic Disorder, sponsored by Daniel Maroti. Withdrawn at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Daniel Maroti · Not applicable, Interventional, and Treatment

Why this study was withdrawn
To few resources
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Somatic Symptom and Related Disorders
  • Somatic Symptom Disorder
  • Functional Somatic Disorder
  • Functional Somatic Syndrome
03

In context

Medically Unexplained Symptoms

71 studies on the registry are indexed under Medically Unexplained Symptoms; 22 are open to participants now.

Browse Medically Unexplained Symptoms studies →

Lead sponsor

Daniel Maroti is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    Group EAET delivered through telehealth

    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.

    Behavioral: Emotional Awareness and Expression Therapy

Interventions

  • BehavioralEmotional Awareness and Expression Therapy

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    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.)

  2. 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").

    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.)

Secondary outcomes

  1. 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.

    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.)

  2. 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.

    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.)

  3. 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.

    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.)

Other outcomes

  1. Negative Effects Questionnaire (NEQ)

    Participants respond to a series of statements regarding potential negative effects they may have experienced during or after therapy, typically using a Likert scale (e.g., 1 = "Not at all," to 5 = "Extremely"). The total score is computed by summing the responses, where higher scores indicate a greater frequency or severity of negative effects.

    Time frame: At post-treatment (after 12 weeks of treatment)

  2. 8 visual analogue scales

    A - 2 questions) 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"). B - 2 questions). On a scale 1-10 (as above) what is the capacity of emotional processing. C - 2 questions) On a scale 1-10 what is the capacity for self-compassion. D - 2 questions) On a scale 1-10 how much of symptoms is attributed to medical causes.

    Time frame: Mediational measure: Each week once a week throughout treatment, i.e. 11 measurement points. Week 2-12.

  3. The Credibility and Expectancy Questionnaire (CEQ)

    The CEQ includes items rated on a Likert scale (e.g., 1 to 9), where patients indicate their level of agreement with statements regarding the credibility and expected outcomes of the treatment.

    Time frame: At treatment session 3 (out of 12)

07

Study locations

1 site
  • Stockholm University
    Stockholm, 10691, Sweden
08

References and documents

Individual participant data

Plan to share: No — Participants has not approved this.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2025 to primary completion in Dec 2025, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2024
First posted
Oct 8, 2024
StartActual
Jan 1, 2025
Primary completionActual
Dec 31, 2025
CompletionActual
Dec 31, 2025
Last update
Jul 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06631963
Lead sponsor
Daniel Maroti
Responsible party
Daniel Maroti (PhD, principal investigator, Stockholm University) — Sponsor-investigator
First posted
Oct 8, 2024
Start date
Jan 1, 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025
Last update
Jul 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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