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Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder - A Randomized Controlled Trial (MBS2)

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ClinicalTrials.gov Identifier: NCT04751825
Recruitment Status : Completed
First Posted : February 12, 2021
Last Update Posted : June 10, 2022
Sponsor:
Collaborators:
Stockholm University
Wayne State University
Information provided by (Responsible Party):
Robert Johansson, Karolinska Institutet

Brief Summary:
The main purpose of this study is to conduct a Randomised Controlled Trial (RCT) where we evaluate an internet administrated version of Emotional Awareness and Expression Therapy (I-EAET) in the treatment of Somatic Symptom Disorder (SSD). We will include 160 patients with SSD that will be randomized to taking part of the Internet based treatment for ten weeks (80 patients) or a waiting list control condition (80 patients). A between-subject design will be used. Self-report measures of symptom level and mechanisms of change will be conducted weekly for the primary outcome measures (PHQ-15, BPI-4) and the process measure (EPS-25). The other self-report measures will be conducted before, after treatment and at follow up at 4-month and 12.

Condition or disease Intervention/treatment Phase
Somatic Symptom Disorder Behavioral: I-EAET Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT with Wait-List condition
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder - A Randomized Controlled Trial
Actual Study Start Date : February 1, 2021
Actual Primary Completion Date : April 15, 2021
Actual Study Completion Date : April 15, 2022

Arm Intervention/treatment
Experimental: I-EAET
Internet administrated Emotional and Awareness and Expression Therapy (I-EAET). 10 weeks. Self-help treatment with therapist contact via text messages at least once a week.
Behavioral: I-EAET
See information in arm description.

No Intervention: WL
Wait-list.



Primary Outcome Measures :
  1. Patient Health Questionnaire-15. Min (0), Max (30), higher score indicate more somatic symptoms [ Time Frame: Baseline ]
    Measuring somatic symptoms

  2. Patient Health Questionnaire-15. Min (0), Max (30), higher score indicate more somatic symptoms [ Time Frame: Post-intervention (10 weeks from start) ]
    Measuring somatic symptoms

  3. Patient Health Questionnaire-15. Min (0), Max (30), higher score indicate more somatic symptoms [ Time Frame: FU at 4 months ]
    Measuring somatic symptoms

  4. Patient Health Questionnaire-15. Min (0), Max (30), higher score indicate more somatic symptoms [ Time Frame: FU at 12 months ]
    Measuring somatic symptoms

  5. Brief Pain Inventory -4, min (0), max (40) higher score indicate more severe symptoms [ Time Frame: Baseline ]
    Measuring pain symptoms

  6. Brief Pain Inventory -4, min (0), max (40) higher score indicate more severe symptoms [ Time Frame: Post-intervention (10 weeks from start) ]
    Measuring pain symptoms

  7. Brief Pain Inventory -4, min (0), max (40) higher score indicate more severe symptoms [ Time Frame: FU at 4 months. ]
    Measuring pain symptoms

  8. Brief Pain Inventory -4, min (0), max (40) higher score indicate more severe symptoms [ Time Frame: FU at 12 months. ]
    Measuring pain symptoms


Secondary Outcome Measures :
  1. Generalized Anxiety Disorder-7, min (0), max (21), higher score indicate more severe symptoms [ Time Frame: Baseline ]
    Measuring anxiety symptoms

  2. Generalized Anxiety Disorder-7, min (0), max (21), higher score indicate more severe symptoms [ Time Frame: Post-intervention (10 weeks from start) ]
    Measuring anxiety symptoms

  3. Generalized Anxiety Disorder-7, min (0), max (21), higher score indicate more severe symptoms [ Time Frame: FU at 4 month ]
    Measuring anxiety symptoms

  4. Generalized Anxiety Disorder-7, min (0), max (21), higher score indicate more severe symptoms [ Time Frame: FU at 12 month ]
    Measuring anxiety symptoms

  5. Patient Health Questionnaire-9, min (0), max (27), higher score indicate more severe symptoms [ Time Frame: Baseline ]
    Measuring depressive symptoms

  6. Patient Health Questionnaire-9, min (0), max (27), higher score indicate more severe symptoms [ Time Frame: Post-intervention (10 weeks from start) ]
    Measuring depressive symptoms

  7. Patient Health Questionnaire-9, min (0), max (27), higher score indicate more severe symptoms [ Time Frame: FU at 4 month ]
    Measuring depressive symptoms

  8. Patient Health Questionnaire-9, min (0), max (27), higher score indicate more severe symptoms [ Time Frame: FU at 12 month ]
    Measuring depressive symptoms

  9. Post-traumatic Stress Disorder CheckList-5, min (0), max (80), higher score indicate more severe symptoms [ Time Frame: Baseline ]
    Measuring post traumatic symptoms

  10. Post-traumatic Stress Disorder CheckList-5, min (0), max (80), higher score indicate more severe symptoms [ Time Frame: Post-intervention (10 weeks from start) ]
    Measuring post traumatic symptoms

  11. Post-traumatic Stress Disorder CheckList-5, min (0), max (80), higher score indicate more severe symptoms [ Time Frame: FU at 4 month ]
    Measuring post traumatic symptoms

  12. Post-traumatic Stress Disorder CheckList-5, min (0), max (80), higher score indicate more severe symptoms [ Time Frame: FU at 12 month ]
    Measuring post traumatic symptoms

  13. Shehan Disability Scale (SDS), min (0), max (30), higher score indicate more severe disability [ Time Frame: Baseline ]
    Measuring activity level in three domains (social, work and leisure time)

  14. Shehan Disability Scale (SDS), min (0), max (30), higher score indicate more severe disability [ Time Frame: Post-intervention (10 weeks from start) ]
    Measuring activity level in three domains (social, work and leisure time)

  15. Shehan Disability Scale (SDS), min (0), max (30), higher score indicate more severe disability [ Time Frame: FU at 4 month ]
    Measuring activity level in three domains (social, work and leisure time)

  16. Shehan Disability Scale (SDS), min (0), max (30), higher score indicate more severe disability [ Time Frame: FU at 12 month ]
    Measuring activity level in three domains (social, work and leisure time)

  17. Epworth Sleepiness Scale, min (0), max (24) higher score indicate more severe symptoms [ Time Frame: Baseline ]
    Measuring sleepiness symptoms from

  18. Epworth Sleepiness Scale, min (0), max (24) higher score indicate more severe symptoms [ Time Frame: Post-intervention (10 weeks from start) ]
    Measuring sleepiness symptoms from

  19. Epworth Sleepiness Scale, min (0), max (24) higher score indicate more severe symptoms [ Time Frame: FU at 4 month ]
    Measuring sleepiness symptoms from

  20. Epworth Sleepiness Scale, min (0), max (24) higher score indicate more severe symptoms [ Time Frame: FU at 12 month ]
    Measuring sleepiness symptoms from

  21. Insomnia Severy Index, min (0), max (21), higher score indicate more severe symptoms [ Time Frame: Baseline ]
    Measuring insomnia symptoms

  22. Insomnia Severy Index, min (0), max (21), higher score indicate more severe symptoms [ Time Frame: Post-intervention (10 weeks from start) ]
    Measuring insomnia symptoms

  23. Insomnia Severy Index, min (0), max (21), higher score indicate more severe symptoms [ Time Frame: FU at 4 month ]
    Measuring insomnia symptoms

  24. Insomnia Severy Index, min (0), max (21), higher score indicate more severe symptoms [ Time Frame: FU at 12 month ]
    Measuring insomnia symptoms

  25. Negative Effects Questionnaire, min (0), max (128), higher score indicate more severe negative effects [ Time Frame: Post-intervention (10 weeks from start) ]
    Measuring Negative Effects

  26. Negative Effects Questionnaire, min (0), max (128), higher score indicate more severe negative effects [ Time Frame: FU at 12 months ]
    Measuring Negative Effects

  27. Level of Emotional Awareness Scale, min (0), max (100), higher score indicate better emotional awareness capacity [ Time Frame: Baseline ]
    Measuring emotional awareness capacity

  28. Level of Emotional Awareness Scale, min (0), max (100), higher score indicate better emotional awareness capacity [ Time Frame: FU 4 month ]
    Measuring emotional awareness capacity

  29. Emotional Processing Scale-25, min (0), max (225), higher score indicates more pronounced difficulties with emotional processing capacity [ Time Frame: Baseline ]
    Measuring emotional processing capacity

  30. Emotional Processing Scale-25, min (0), max (225), higher score indicates more pronounced difficulties with emotional processing capacity [ Time Frame: Post-intervention (10 weeks from start) ]
    Measuring emotional processing capacity

  31. Emotional Processing Scale-25, min (0), max (225), higher score indicates more pronounced difficulties with emotional processing capacity [ Time Frame: FU 4 month ]
    Measuring emotional processing capacity

  32. Emotional Processing Scale-25, min (0), max (225), higher score indicates more pronounced difficulties with emotional processing capacity [ Time Frame: FU at 12 months ]
    Measuring emotional processing capacity


Other Outcome Measures:
  1. Process measure: Generalized Anxiety Disorder-2, min (0), max (6), higher score indicates more pronounced symptoms [ Time Frame: During treatment: Once every week for 10 weeks ]
    Measuring anxiety symptoms

  2. Process measure: Patient Health Questionnaire-2, min (0), max (6), higher score indicates more pronounced symptoms [ Time Frame: During treatment: Once every week for 10 weeks ]
    Measuring depressive symptoms

  3. Process measure: Emotional Processing Scale-25, min (0), max (225), higher score indicates more pronounced difficulties with emotional processing capacity [ Time Frame: During treatment: Once every week for 10 weeks ]
    Measuring emotional processing capacity

  4. Process measure: Patient Health Questionnaire-15. Min (0), Max (30), higher score indicate more somatic symptoms [ Time Frame: During treatment: Once every week for 10 weeks ]
    Measuring diverse somatic symptoms

  5. Process measure: Brief Pain Inventory-4, min (0), max (40) higher score indicate more severe symptoms [ Time Frame: During treatment: Once every week for 10 weeks ]
    Measuring pain symptoms



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 18 years
  • A total score ≥5 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 symptom, 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
  • Ongoing psychological intervention or psychotherapy that target somatic symptoms
  • Ongoing medical treatment that may interfere with the psychological treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04751825


Locations
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Sweden
Karolinska Institute
Stockholm, Sweden, 17177
Sponsors and Collaborators
Karolinska Institutet
Stockholm University
Wayne State University
Investigators
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Principal Investigator: Robert Johansson, PhD Karolinska Insitutet
Publications:
Schubiner H, Betzold M. Unlearn your pain : a 28-day process to reprogram your brain. Pleasant Ridge, MI: Mind Body Publishing; 2012.

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Responsible Party: Robert Johansson, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04751825    
Other Study ID Numbers: KIMBS2
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Johansson, Karolinska Institutet:
Emotional Awareness and Expression Therapy
Somatic symptom disorder
Central sensitisation
Fibromyalgia
Pain
Self-help
Emotional processing
Trauma
Additional relevant MeSH terms:
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Disease
Medically Unexplained Symptoms
Pathologic Processes