Clinical trial NCT06301360: Internet Based Emotional Awareness and Expression Therapy for Functional Somatic Disorder With and Without Therapist Support
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Somatic Disorder
Somatic Symptom Disorder
Functional Somatic Syndromes
Keywords: Internet based interventions
EAET
Psychodynamic therapy
Lead sponsor: Stockholm University
Sponsor class: OTHER
Collaborators: name: Wayne State University
First posted: 2024-03-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT with two treatment arms
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Patient Health Questionnaire -15 (PHQ-15)
timeFrame: Change from pre to post treatment (after 10 weeks of treatment)
measure: Numeric Rating Scales according to EURONET-SOMA
timeFrame: Change from pre to post treatment (after 10 weeks of treatment)
Secondary outcomes:
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Change from pre to post treatment (after 10 weeks of treatment)
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Change from pre to post treatment (after 10 weeks of treatment)
measure: Post traumatic stress disorder checklist-5 (PCL-5)
timeFrame: Change from pre to post treatment (after 10 weeks of treatment)
measure: Difficulties in Emotion Regulation Scale-16 (DERS-16)
timeFrame: Change from pre to post treatment (after 10 weeks of treatment)
measure: Sheehan Disability Scale (SDS)
timeFrame: Change from pre to post treatment (after 10 weeks of treatment)
measure: The revised illness perception questionnaire (IPQ-R)
timeFrame: Change from pre to post treatment (after 10 weeks of treatment)
Other outcomes:
measure: Mediational measure: DERS-16
timeFrame: Each week once a week throughout 10 weeks of treatment
measure: Mediational measure: PHQ-15
timeFrame: Each week once a week throughout 10 weeks of treatment
measure: Mediational measure: PHQ-4
timeFrame: Each week once a week throughout 10 weeks of treatment
Locations:
city: Stockholm
country: Sweden
facility: Stockholm University
city: Stockholm
country: Sweden
facility: Stockholm University
Study officials:
References: