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

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Completed
• CT.gov ID: NCT04122846
• Collaborator: Stockholm University (Other)
• Enrollment: 50
• Location: 1
• Arm: 1
• Actual Duration (Months): 6
• Patients Per Site Per Month: 8.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Somatic Symptom Disorder	Behavioral: Emotional Awareness and Expression Therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Emotional Awareness and Expression TherapyEmotional Awareness and Expression Therapy
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder
• Actual Study Start Date: Sep 30, 2019
• Actual Primary Completion Date: Apr 1, 2020
• Actual Study Completion Date: Apr 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. PHQ-15 [Baseline]

   Patient Health Questionnaire Physical Symptoms

2. PHQ-15 [Weekly during treatment, for 9 weeks]

   Change in physical symptoms (as measured by the PHQ-15)

3. PHQ-15 [At study completion, after 9 weeks]

   Patient Health Questionnaire Physical Symptoms

4. PHQ-15 [At study completion, after 4 months]

   Patient Health Questionnaire Physical Symptoms

Secondary Outcome Measures

1. PHQ-9 [Baseline]

   Patient Health Questionnaire Depression

2. PHQ-9 [At study completion, after 9 weeks]

   Patient Health Questionnaire Depression

3. PHQ-9 [At study completion, after 4 months]

   Patient Health Questionnaire Depression

4. GAD-7 [Baseline]

   Patient Health Questionnaire Anxiety

5. GAD-7 [At study completion, after 9 weeks]

   Patient Health Questionnaire Anxiety

6. GAD-7 [At study completion, after 4 months]

   Patient Health Questionnaire Anxiety

7. SDS [Baseline]

   Sheehan Disability Scale

8. SDS [At study completion, after 9 weeks]

   Sheehan Disability Scale

9. SDS [At study completion, after 4 months]

   Sheehan Disability Scale

Other Outcome Measures

1. EPS-25 [Baseline]

   Emotional Processing Scale (Measure of treatment process)

2. EPS-25 [Weekly during treatment, for 9 weeks]

   Emotional Processing Scale (Measure of treatment process)

3. EPS-25 [At study completion, after 9 weeks]

   Emotional Processing Scale (Measure of treatment process)

4. EPS-25 [At study completion, after 4 months]

   Emotional Processing Scale (Measure of treatment process)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska Institutet	Stockholm		Sweden

Sponsors and Collaborators

• Karolinska Institutet
• Stockholm University

Investigators

• Principal Investigator: Robert Johansson, PhD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Robert Johansson, Associate professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT04122846
• Other Study ID Numbers: KIMBS1
• First Posted: Oct 10, 2019
• Last Update Posted: Apr 16, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Medically Unexplained Symptoms

Study Results

No Results Posted as of Apr 16, 2020