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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2019

Interventions

  • Behavioral: Emotional Awareness and Expression Therapy
    • Very much based on “Unlearn your pain” by Howard Schubiner.

Arms, Groups and Cohorts

  • Experimental: Treatment (Emotional Awareness and Expression Therapy)
    • Internet-based Emotional Awareness and Expression Therapy

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • PHQ-9
    • Time Frame: Baseline
    • Patient Health Questionnaire Depression
  • PHQ-9
    • Time Frame: At study completion, after 9 weeks
    • Patient Health Questionnaire Depression
  • GAD-7
    • Time Frame: Baseline
    • Patient Health Questionnaire Anxiety
  • GAD-7
    • Time Frame: At study completion, after 9 weeks
    • Patient Health Questionnaire Anxiety
  • SDS
    • Time Frame: Baseline
    • Sheehan Disability Scale
  • SDS
    • Time Frame: At study completion, after 9 weeks
    • Sheehan Disability Scale

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Karolinska Institutet
  • Collaborator
    • Stockholm University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Robert Johansson, Associate professor – Karolinska Institutet
  • Overall Official(s)
    • Robert Johansson, PhD, Principal Investigator, Karolinska Institutet

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