MedTrace Logo

Internet Based Emotional Awareness and Expression Therapy for Functional Somatic Disorder With and Without Therapist Support

NCT06301360 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-03-12

No results posted yet for this study

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?

Conditions

  • Functional Somatic Disorder
  • Somatic Symptom Disorder
  • Functional Somatic Syndromes

Interventions

BEHAVIORAL

Internet based Emotional Awareness and Expression Therapy (I-EAET)

In I-EAET with therapist support, the therapist and participants communicate asynchronous using written messages. The therapist gives feedback each week on home-work assignments and is available on demand for support. In I-EAET without therapist support, the participants works with home-work assignments on their own and only have technical support.

Sponsors & Collaborators

  • Wayne State University

    collaborator OTHER

  • Daniel Maroti

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-06-01
Completion
2025-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06301360 on ClinicalTrials.gov