Online therapy for emotional awareness in patients with functional somatic disorders
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
This study is testing an online therapy to help people with functional somatic disorders, like irritable bowel syndrome and fibromyalgia, better understand and express their emotions to see if it can reduce their symptoms and improve their care experience.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stockholm University Academic / other |
| Locations | 2 sites (Stockholm and 1 other locations) |
| Trial ID | NCT06301360 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Internet-based Emotional Awareness and Expression Therapy (I-EAET) for patients suffering from functional somatic disorders, which include conditions like irritable bowel syndrome and fibromyalgia. The approach focuses on enhancing emotional awareness and expression to alleviate distress associated with bodily symptoms. Participants will engage in therapy either with or without therapist support, aiming to improve their overall satisfaction with care and reduce the frequency of doctor visits. The study is set in Stockholm, Sweden, and targets individuals who have experienced emotional difficulties related to their physical symptoms.
Who should consider this trial
Good fit: Ideal candidates are individuals who have medically unexplained symptoms and express interest in exploring the emotional aspects of their condition.
Not a fit: Patients with ongoing substance abuse or serious mental illnesses may not benefit from this therapy.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the quality of life for patients with functional somatic disorders by addressing emotional factors contributing to their symptoms.
How similar studies have performed: Previous studies have shown promising results for short-term psychodynamic therapies in treating medically unexplained symptoms, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Stockholm and 1 other locations
- Stockholm University — Stockholm, Sweden (Recruiting)
- Stockholm University — Stockholm, Sweden (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.