Clinical trial NCT06631963: Telehealth Group-based Emotional Awareness and Expression Therapy for Patients With Persistent Physical Symptoms: A Pilot Study
Official title: Telehealth Group-based Emotional Awareness and Expression Therapy for Patients With Persistent Physical Symptoms: A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Somatic Symptom and Related Disorders
Somatic Symptom Disorder
Functional Somatic Disorder
Functional Somatic Syndrome
Lead sponsor: Stockholm University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Patient Health Questionaire-15 (PHQ-15)
timeFrame: 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.)
measure: Visual Analoge Scales
timeFrame: 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:
measure: Patient Health Questionaire-9 (PHQ-9)
timeFrame: 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.)
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: 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.)
measure: Post traumatic symptom Check List-5 (PCL-5)
timeFrame: 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:
measure: Negative Effects Questionnaire (NEQ)
timeFrame: At post-treatment (after 12 weeks of treatment)
measure: 8 visual analogue scales
timeFrame: Mediational measure: Each week once a week throughout treatment, i.e. 11 measurement points. Week 2-12.
measure: The Credibility and Expectancy Questionnaire (CEQ)
timeFrame: At treatment session 3 (out of 12)
Locations:
city: Stockholm
country: Sweden
facility: Stockholm University
Study officials:
References: