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

Somatic Symptom Disorder Clinical Trial

— MBS1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04122846
• Other study ID #: KIMBS1
• Status: Completed
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: April 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medically Unexplained Symptoms
• Somatic Symptom Disorder

Intervention

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

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	EPS-25	Emotional Processing Scale (Measure of treatment process)	Baseline
Other	EPS-25	Emotional Processing Scale (Measure of treatment process)	Weekly during treatment, for 9 weeks
Other	EPS-25	Emotional Processing Scale (Measure of treatment process)	At study completion, after 9 weeks
Other	EPS-25	Emotional Processing Scale (Measure of treatment process)	At study completion, after 4 months
Primary	PHQ-15	Patient Health Questionnaire Physical Symptoms	Baseline
Primary	PHQ-15	Change in physical symptoms (as measured by the PHQ-15)	Weekly during treatment, for 9 weeks
Primary	PHQ-15	Patient Health Questionnaire Physical Symptoms	At study completion, after 9 weeks
Primary	PHQ-15	Patient Health Questionnaire Physical Symptoms	At study completion, after 4 months
Secondary	PHQ-9	Patient Health Questionnaire Depression	Baseline
Secondary	PHQ-9	Patient Health Questionnaire Depression	At study completion, after 9 weeks
Secondary	PHQ-9	Patient Health Questionnaire Depression	At study completion, after 4 months
Secondary	GAD-7	Patient Health Questionnaire Anxiety	Baseline
Secondary	GAD-7	Patient Health Questionnaire Anxiety	At study completion, after 9 weeks
Secondary	GAD-7	Patient Health Questionnaire Anxiety	At study completion, after 4 months
Secondary	SDS	Sheehan Disability Scale	Baseline
Secondary	SDS	Sheehan Disability Scale	At study completion, after 9 weeks
Secondary	SDS	Sheehan Disability Scale	At study completion, after 4 months