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

Somatic Symptom Disorder Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06301360
• Other study ID #: KOSMOS2 2023-04956-01
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Stockholm University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Medically Unexplained Symptoms
• Somatic Symptom Disorder

Intervention

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.

Locations

Country	Name	City	State
Sweden	Stockholm University	Stockholm
Sweden	Stockholm University	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Daniel Maroti	Wayne State University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	The revised illness perception questionnaire (IPQ-R)	Ratings on illness beliefs.	Change from pre to post treatment (after 10 weeks of treatment)

External Links

•   Information about study project at Stockholm University