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

NCT06631963 | Not Yet Recruiting

• 1 other identifier: KOSMOS3-Grupp
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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.)

• 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.)

• 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.)

Other Outcomes (3)

• Negative Effects Questionnaire (NEQ)

  At post-treatment (after 12 weeks of treatment)

• 8 visual analogue scales

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

• The Credibility and Expectancy Questionnaire (CEQ)

  At treatment session 3 (out of 12)

Study Arms (1)

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.

Behavioral: Emotional Awareness and Expression Therapy

Interventions

Emotional Awareness and Expression Therapy BEHAVIORAL

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.

Group EAET delivered through telehealth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daniel Maroti: lead

Study Sites (1)

Stockholm University

Stockholm, 10691, Sweden

Location

MeSH Terms

Conditions

Medically Unexplained Symptoms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, principal investigator

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 8, 2024
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)