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Completed

NCT Number: NCT06301360

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

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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stockholm University, Stockholm, Stockholm County, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. Patient Health Questionnaire -15 (PHQ-15)

    Time frame: Change from pre to post treatment (after 10 weeks of treatment)

    Ratings 0-2 on how troublesome somatic symptoms are experienced. Higher scores indicates worse symptom/functioning.

  2. Numeric Rating Scales according to EURONET-SOMA

    Time frame: Change from pre to post treatment (after 10 weeks of treatment)

    Visual analogue scale 0-10 for symptom intensity and symptom interference. Higher scores indicates worse symptom/functioning.

Secondary outcomes

  1. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Change from pre to post treatment (after 10 weeks of treatment)

    Ratings 0-3 on impact of anxiety symptoms. Higher scores indicates worse symptom/functioning.

  2. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Change from pre to post treatment (after 10 weeks of treatment)

    Ratings 0-3 on impact of depressive symptoms. Higher scores indicates worse symptom/functioning.

  3. Post traumatic stress disorder checklist-5 (PCL-5)

    Time frame: Change from pre to post treatment (after 10 weeks of treatment)

    Ratings 0-4 on impact of post traumatic symptoms. Higher scores indicates worse symptom/functioning.

  4. Difficulties in Emotion Regulation Scale-16 (DERS-16)

    Time frame: Change from pre to post treatment (after 10 weeks of treatment)

    Ratings on emotional (dys)regulation. Higher scores indicates worse symptom/functioning.

  5. Sheehan Disability Scale (SDS)

    Time frame: Change from pre to post treatment (after 10 weeks of treatment)

    Visual analogue scale 0-10 for symptom interference in daily life. Higher scores indicates worse symptom/functioning.

  6. The revised illness perception questionnaire (IPQ-R)

    Time frame: Change from pre to post treatment (after 10 weeks of treatment)

    Ratings on illness beliefs.

Other outcomes

  1. Mediational measure: DERS-16

    Time frame: Each week once a week throughout 10 weeks of treatment

    Ratings on emotional (dys)regulation. Higher scores indicates worse symptom/functioning.

  2. Mediational measure: PHQ-15

    Time frame: Each week once a week throughout 10 weeks of treatment

    Ratings 0-2 on how troublesome somatic symptoms are experienced. Higher scores indicates worse symptom/functioning.

  3. Mediational measure: PHQ-4

    Time frame: Each week once a week throughout 10 weeks of treatment

    Ratings 0-2 on how troublesome somatic symptoms are experienced. Higher scores indicates worse symptom/functioning.

Sponsors and collaborators

Lead sponsor

Daniel Maroti

Other

Collaborators

  • Wayne State University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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