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

Last updated: March 8, 2024
Sponsor: Daniel Maroti
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anxiety Disorders

Hypochondriasis

Functional Dyspepsia

Treatment

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

Clinical Study ID

NCT06301360
KOSMOS2 2023-04956-01
  • Ages > 18
  • All Genders

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?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The research subject certifies that he/she has undergone medical assessment forhis/her physical symptoms.
  • The subject rates either moderate distress from bodily symptoms in the PHQ-15 (over 10points) or severe distress from a single bodily symptom (at least 2 points for thissymptom).
  • The research participants expresses interest in investigating whether emotionalfactors 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 reachthe proposed cut-off point of 23p in the PCL-5).
  • Drugs used should have been stable for at least 1 month.

Exclusion

Exclusion Criteria:

  • Research subjects suffer from ongoing substance abuse (alcohol or drugs) or are deemedto have serious mental illness (psychotic illness, suicidal ideation, antisocialpersonality disorder etc).
  • The research subjects have ongoing medication of a clearly addictive and sedativenature (e.g. benzodiazepines).
  • The research subject participates in other psychological treatment focusing onphysical symptoms. However, other psychological treatment is allowed where the supporttherapy does not take place more often than once a month.
  • The research subject does not master the Swedish language sufficiently to be able toassimilate written material in Swedish.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Internet based Emotional Awareness and Expression Therapy (I-EAET)
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Stockholm University

    Stockholm, 10691
    Sweden

    Active - Recruiting

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