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Clinical Trials/NCT04122846
NCT04122846
Completed
N/A

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

Karolinska Institutet1 site in 1 country50 target enrollmentSeptember 30, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Somatic Symptom Disorder
Sponsor
Karolinska Institutet
Enrollment
50
Locations
1
Primary Endpoint
PHQ-15
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 30, 2019
End Date
April 1, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert Johansson

Associate professor

Karolinska Institutet

Eligibility Criteria

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

Outcomes

Primary Outcomes

PHQ-15

Time Frame: At study completion, after 4 months

Patient Health Questionnaire Physical Symptoms

Secondary Outcomes

  • PHQ-9(At study completion, after 4 months)
  • GAD-7(At study completion, after 4 months)
  • SDS(At study completion, after 4 months)

Study Sites (1)

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