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

Study Overview
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Brief Summary
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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.

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

Conditions
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Somatic Symptom Disorder

Intervention / Treatment
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* Behavioral: Emotional Awareness and Expression Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Emotional Awareness and Expression Therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (Emotional Awareness and Expression Therapy)<br>Internet-based Emotional Awareness and Expression Therapy | Behavioral: Emotional Awareness and Expression Therapy<br>* Very much based on Unlearn your pain by Howard Schubiner.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PHQ-15 | Patient Health Questionnaire Physical Symptoms | Baseline | 
| PHQ-15 | Change in physical symptoms (as measured by the PHQ-15) | Weekly during treatment, for 9 weeks | 
| PHQ-15 | Patient Health Questionnaire Physical Symptoms | At study completion, after 9 weeks | 
| PHQ-15 | Patient Health Questionnaire Physical Symptoms | At study completion, after 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PHQ-9 | Patient Health Questionnaire Depression | Baseline | 
| PHQ-9 | Patient Health Questionnaire Depression | At study completion, after 9 weeks | 
| PHQ-9 | Patient Health Questionnaire Depression | At study completion, after 4 months | 
| GAD-7 | Patient Health Questionnaire Anxiety | Baseline | 
| GAD-7 | Patient Health Questionnaire Anxiety | At study completion, after 9 weeks | 
| GAD-7 | Patient Health Questionnaire Anxiety | At study completion, after 4 months | 
| SDS | Sheehan Disability Scale | Baseline | 
| SDS | Sheehan Disability Scale | At study completion, after 9 weeks | 
| SDS | Sheehan Disability Scale | At study completion, after 4 months |