How Much Does the Therapist Matter in Internet Based Emotional Awareness and Expression Therapy (I-EAET) for Functional Somatic Disorder? A Randomised Controlled Trial of I-EAET With and Without Therapist Support

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Functional somatic syndromes (e.g. irritable bowel syndrome, fibromyalgia) and medically unexplained symptoms (e.g. chronic primary pain) are very common in primary care. These patients make 14 times more doctor visits than the general population, but describe themselves as less satisfied with the care they receive. Although Region Stockholm in Sweden recently developed care flows based on 'step up' care for the most common patient groups in primary care, patients with functional or medically unexplained symptoms are not mentioned. Short-term psychodynamic therapies such as Emotional Awareness and Expression Therapy (EAET) and Intensive Short Term Psychodynamic Therapy (ISTDP) have recently been evaluated in three systematic reviews and show good results for patients with medically unexplained symptoms. Short-term psychodynamic therapy considers that good treatment outcomes for patients with functional somatic syndromes can be achieved by increasing awareness of emotions and teaching patients to better experience, express and regulate emotions. In several randomized studies, short-term psychodynamic therapy has shown good effects even compared to other treatments, including cognitive behavioral therapy (CBT). The overall purpose of this research project is to to evaluate psychodynamic emotion-focused interventions (EAET and ISTDP) for patients with medically unexplained symptoms/functional somatic symptoms (MUS/FSD). The project includes several studies that will clarify effects and contribute to information on how care flows in primary care for the patient group can be created. The research question for this specific study is: Is internet-based Emotional Awareness and Expression Therapy (I-EAET) with therapist more effective than without therapist support for patients with FSD?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• The research subject certifies that he/she has undergone medical assessment for his/her physical symptoms.

• The subject rates either moderate distress from bodily symptoms in the PHQ-15 (over 10 points) or severe distress from a single bodily symptom (at least 2 points for this symptom).

• The research participants expresses interest in investigating whether emotional factors such as stress may contribute to symptoms.

• Research subjects either affirm the presence of emotionally difficult life events (affirm at least 1 such event in the Adverse Childhood Experience (ACE-10) or reach the proposed cut-off point of 23p in the PCL-5).

• Drugs used should have been stable for at least 1 month.

Locations
Other Locations
Sweden
Stockholm University
RECRUITING
Stockholm
Stockholm University
RECRUITING
Stockholm
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 150
Treatments
Experimental: I-EAET with therapist support
I-EAET is a 10 week treatment intervention combining principles from emotion focused therapies and neuroscience. Main components include psychoeducation on the body-mind connection, anxiety regulation with self-compassion exercises and different techniques for emotional exposure and processing. Participants have help from a therapist giving feedback.
Active_comparator: I-EAET without therapist support
I-EAET is a 10 week treatment intervention combining principles from emotion focused therapies and neuroscience. Main components include psychoeducation on the body-mind connection, anxiety regulation with self-compassion exercises and different techniques for emotional exposure and processing. Participants works on their own and have only technical support.
Sponsors
Leads: Daniel Maroti
Collaborators: Wayne State University

This content was sourced from clinicaltrials.gov