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

Study Overview

• Status: Not yet recruiting
• Conditions: Somatic Symptom Disorder; Somatic Symptom and Related Disorders; Functional Somatic Disorder; Functional Somatic Syndrome
• Intervention / Treatment: Behavioral: Emotional Awareness and Expression Therapy

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 10691
    • Stockholm University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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").	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At post-treatment (after 12 weeks of treatment)
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.	Mediational measure: Each week once a week throughout treatment, i.e. 11 measurement points. Week 2-12.
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.	At treatment session 3 (out of 12)

Collaborators and Investigators

• Sponsor: Daniel Maroti

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Medically Unexplained Symptoms
• Other Study ID Numbers: KOSMOS3-Grupp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participants has not approved this.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No