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

Primary Purpose

Somatic Symptom Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Emotional Awareness and Expression Therapy
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Somatic Symptom Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (Emotional Awareness and Expression Therapy)

Arm Description

Internet-based Emotional Awareness and Expression Therapy

Outcomes

Primary Outcome Measures

PHQ-15
Patient Health Questionnaire Physical Symptoms
PHQ-15
Change in physical symptoms (as measured by the PHQ-15)
PHQ-15
Patient Health Questionnaire Physical Symptoms
PHQ-15
Patient Health Questionnaire Physical Symptoms

Secondary Outcome Measures

PHQ-9
Patient Health Questionnaire Depression
PHQ-9
Patient Health Questionnaire Depression
PHQ-9
Patient Health Questionnaire Depression
GAD-7
Patient Health Questionnaire Anxiety
GAD-7
Patient Health Questionnaire Anxiety
GAD-7
Patient Health Questionnaire Anxiety
SDS
Sheehan Disability Scale
SDS
Sheehan Disability Scale
SDS
Sheehan Disability Scale

Full Information

First Posted
October 4, 2019
Last Updated
April 15, 2020
Sponsor
Karolinska Institutet
Collaborators
Stockholm University
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1. Study Identification

Unique Protocol Identification Number
NCT04122846
Brief Title
Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder
Acronym
MBS1
Official Title
Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Stockholm University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Somatic Symptom Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Emotional Awareness and Expression Therapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (Emotional Awareness and Expression Therapy)
Arm Type
Experimental
Arm Description
Internet-based Emotional Awareness and Expression Therapy
Intervention Type
Behavioral
Intervention Name(s)
Emotional Awareness and Expression Therapy
Intervention Description
Very much based on "Unlearn your pain" by Howard Schubiner.
Primary Outcome Measure Information:
Title
PHQ-15
Description
Patient Health Questionnaire Physical Symptoms
Time Frame
Baseline
Title
PHQ-15
Description
Change in physical symptoms (as measured by the PHQ-15)
Time Frame
Weekly during treatment, for 9 weeks
Title
PHQ-15
Description
Patient Health Questionnaire Physical Symptoms
Time Frame
At study completion, after 9 weeks
Title
PHQ-15
Description
Patient Health Questionnaire Physical Symptoms
Time Frame
At study completion, after 4 months
Secondary Outcome Measure Information:
Title
PHQ-9
Description
Patient Health Questionnaire Depression
Time Frame
Baseline
Title
PHQ-9
Description
Patient Health Questionnaire Depression
Time Frame
At study completion, after 9 weeks
Title
PHQ-9
Description
Patient Health Questionnaire Depression
Time Frame
At study completion, after 4 months
Title
GAD-7
Description
Patient Health Questionnaire Anxiety
Time Frame
Baseline
Title
GAD-7
Description
Patient Health Questionnaire Anxiety
Time Frame
At study completion, after 9 weeks
Title
GAD-7
Description
Patient Health Questionnaire Anxiety
Time Frame
At study completion, after 4 months
Title
SDS
Description
Sheehan Disability Scale
Time Frame
Baseline
Title
SDS
Description
Sheehan Disability Scale
Time Frame
At study completion, after 9 weeks
Title
SDS
Description
Sheehan Disability Scale
Time Frame
At study completion, after 4 months
Other Pre-specified Outcome Measures:
Title
EPS-25
Description
Emotional Processing Scale (Measure of treatment process)
Time Frame
Baseline
Title
EPS-25
Description
Emotional Processing Scale (Measure of treatment process)
Time Frame
Weekly during treatment, for 9 weeks
Title
EPS-25
Description
Emotional Processing Scale (Measure of treatment process)
Time Frame
At study completion, after 9 weeks
Title
EPS-25
Description
Emotional Processing Scale (Measure of treatment process)
Time Frame
At study completion, after 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Johansson, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33679478
Citation
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.
Results Reference
derived

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

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