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

Not Applicable

Completed

• Conditions: Somatic Symptom Disorder
• Interventions: Behavioral: Emotional Awareness and Expression Therapy

• Registration Number: NCT04122846
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-09-30
• Study First Submitted: 2019-10-04
• Study First Submitted QC: 2019-10-09
• Study First Posted: 2019-10-10
• Status Verified: 2020-04
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Last Update Submitted: 2020-04-15
• Last Update Posted: 2020-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (Emotional Awareness and Expression Therapy)	Emotional Awareness and Expression Therapy	Internet-based Emotional Awareness and Expression Therapy

Primary Outcome Measures

Name	Time	Method
PHQ-15	At study completion, after 4 months	Patient Health Questionnaire Physical Symptoms

Secondary Outcome Measures

Name	Time	Method
PHQ-9	At study completion, after 4 months	Patient Health Questionnaire Depression
GAD-7	At study completion, after 4 months	Patient Health Questionnaire Anxiety
SDS	At study completion, after 4 months	Sheehan Disability Scale

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden