Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder (MBS1)

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 Overview

• Status: Completed
• Conditions: Somatic Symptom Disorder
• Intervention / Treatment: Behavioral: Emotional Awareness and Expression Therapy

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
EPS-25	Emotional Processing Scale (Measure of treatment process)	Baseline
EPS-25	Emotional Processing Scale (Measure of treatment process)	Weekly during treatment, for 9 weeks
EPS-25	Emotional Processing Scale (Measure of treatment process)	At study completion, after 9 weeks
EPS-25	Emotional Processing Scale (Measure of treatment process)	At study completion, after 4 months

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Stockholm University
• Investigators: Principal Investigator: Robert Johansson, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• Maroti D, Ek J, Widlund RM, Schubiner H, Lumley MA, Lilliengren P, Bileviciute-Ljungar I, Ljotsson B, Johansson R. Internet-Administered Emotional Awareness and Expression Therapy for Somatic Symptom Disorder With Centralized Symptoms: A Preliminary Efficacy Trial. Front Psychiatry. 2021 Feb 12;12:620359. doi: 10.3389/fpsyt.2021.620359. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Medically Unexplained Symptoms
• Other Study ID Numbers: KIMBS1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No