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

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

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06631963
Enrollment
0
Registered
2024-10-08
Start date
2025-01-01
Completion date
2025-12-31
Last updated
2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Somatic Disorder, Functional Somatic Syndrome, Somatic Symptom and Related Disorders, Somatic Symptom Disorder

Brief 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.

Interventions

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.

Sponsors

Daniel Maroti
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Patient Health Questionaire-15 (PHQ-15)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 ScalesChange 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").

Secondary

MeasureTime frameDescription
Patient Health Questionaire-9 (PHQ-9)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.)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.
Generalized Anxiety Disorder 7-item scale (GAD-7)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.)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.
Post traumatic symptom Check List-5 (PCL-5)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.)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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026