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

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

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?

Study Overview

• Status: Recruiting
• Conditions: Somatic Symptom Disorder; Functional Somatic Disorder; Functional Somatic Syndromes
• Intervention / Treatment: Behavioral: Internet based Emotional Awareness and Expression Therapy (I-EAET)

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 10691
    • Recruiting
    • Stockholm University
    • Contact: Daniel Maroti, Med Dr; Phone Number: +46738028474; Email: daniel.maroti@su.se
  • Stockholm, Sweden, 11419
    • Recruiting
    • Stockholm University
    • Contact: Daniel Maroti; Phone Number: 0738028474; Email: daniel.maroti@su.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire -15 (PHQ-15)	Ratings 0-2 on how troublesome somatic symptoms are experienced. Higher scores indicates worse symptom/functioning.	Change from pre to post treatment (after 10 weeks of treatment)
Numeric Rating Scales according to EURONET-SOMA	Visual analogue scale 0-10 for symptom intensity and symptom interference. Higher scores indicates worse symptom/functioning.	Change from pre to post treatment (after 10 weeks of treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalized Anxiety Disorder-7 (GAD-7)	Ratings 0-3 on impact of anxiety symptoms. Higher scores indicates worse symptom/functioning.	Change from pre to post treatment (after 10 weeks of treatment)
Patient Health Questionnaire-9 (PHQ-9)	Ratings 0-3 on impact of depressive symptoms. Higher scores indicates worse symptom/functioning.	Change from pre to post treatment (after 10 weeks of treatment)
Post traumatic stress disorder checklist-5 (PCL-5)	Ratings 0-4 on impact of post traumatic symptoms. Higher scores indicates worse symptom/functioning.	Change from pre to post treatment (after 10 weeks of treatment)
Difficulties in Emotion Regulation Scale-16 (DERS-16)	Ratings on emotional (dys)regulation. Higher scores indicates worse symptom/functioning.	Change from pre to post treatment (after 10 weeks of treatment)
Sheehan Disability Scale (SDS)	Visual analogue scale 0-10 for symptom interference in daily life. Higher scores indicates worse symptom/functioning.	Change from pre to post treatment (after 10 weeks of treatment)
The revised illness perception questionnaire (IPQ-R)	Ratings on illness beliefs.	Change from pre to post treatment (after 10 weeks of treatment)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mediational measure: DERS-16	Ratings on emotional (dys)regulation. Higher scores indicates worse symptom/functioning.	Each week once a week throughout 10 weeks of treatment
Mediational measure: PHQ-15	Ratings 0-2 on how troublesome somatic symptoms are experienced. Higher scores indicates worse symptom/functioning.	Each week once a week throughout 10 weeks of treatment
Mediational measure: PHQ-4	Ratings 0-2 on how troublesome somatic symptoms are experienced. Higher scores indicates worse symptom/functioning.	Each week once a week throughout 10 weeks of treatment

Collaborators and Investigators

• Sponsor: Daniel Maroti
• Collaborators: Wayne State University

Publications and helpful links

Helpful Links

• Information about study project at Stockholm University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: March 3, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Psychodynamic therapy; Internet based interventions; EAET
• Additional Relevant MeSH Terms: Medically Unexplained Symptoms
• Other Study ID Numbers: KOSMOS2 2023-04956-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Original data shared on demand from other researchers and after approval from Swedish Ethical Review Authority.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No