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Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder

Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04122846
Acronym
MBS1
Enrollment
50
Registered
2019-10-10
Start date
2019-09-30
Completion date
2020-04-01
Last updated
2020-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Somatic Symptom Disorder

Brief summary

The main purpose of the study is to conduct an initial feasibility evaluation of the new Internet-based EAET treatment manual. We will include 50 patients with somatic symptom disorder to take part of the treatment for nine weeks through the Internet. A within-subject design will be used. Self-report measures of symptom level and mechanisms of change will be conducted weekly. Feedback on content, process and potential caveats will be collected using surveys and written evaluations from the participants at post-treatment. Linear mixed models will be used to investigate trajectories of change in symptoms and processes.

Interventions

Very much based on Unlearn your pain by Howard Schubiner.

Sponsors

Stockholm University
CollaboratorOTHER
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Emotional Awareness and Expression Therapy

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age over 18 years * A total score ≥10 on the PHQ-15 * A diagnosis of SSD according to the DSM-5, i.e ≥1 of the 3 of: disproportionate thoughts about the somatic symtom, persistently high level of anxiety, or excessive time and energy devoted in regard to symptoms or health concerns * Symptom duration ≥6 months * Written statement from a medical professional that states that a medical evaluation has been conducted.

Exclusion criteria

* Alcohol or substance addiction * A diagnosis of a psychological condition that might require other treatment (e.g., psychosis, suicidality, etc) * Other severe medical condition that might require other treatment * Ongoing psychological intervention or psychotherapy that may interfere with the psychological treatment * Ongoing medical treatment that may interfere with the psychological treatment

Design outcomes

Primary

MeasureTime frameDescription
PHQ-15BaselinePatient Health Questionnaire Physical Symptoms

Secondary

MeasureTime frameDescription
PHQ-9BaselinePatient Health Questionnaire Depression
GAD-7BaselinePatient Health Questionnaire Anxiety
SDSBaselineSheehan Disability Scale

Other

MeasureTime frameDescription
EPS-25BaselineEmotional Processing Scale (Measure of treatment process)

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026