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

NCT04751825 | Completed

• 1 other identifier: KIMBS2
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Somatic Symptom Disorder

Keywords

Emotional Awareness and Expression Therapy; Somatic symptom disorder; Central sensitisation; Fibromyalgia; Pain; Self-help; Emotional processing; Trauma

Outcome Measures

Primary Outcomes (8)

• Patient Health Questionnaire-15. Min (0), Max (30), higher score indicate more somatic symptoms

  Measuring somatic symptoms

  Baseline

• Patient Health Questionnaire-15. Min (0), Max (30), higher score indicate more somatic symptoms

  Measuring somatic symptoms

  Post-intervention (10 weeks from start)

• Patient Health Questionnaire-15. Min (0), Max (30), higher score indicate more somatic symptoms

  Measuring somatic symptoms

  FU at 4 months

• Patient Health Questionnaire-15. Min (0), Max (30), higher score indicate more somatic symptoms

  Measuring somatic symptoms

  FU at 12 months

• Brief Pain Inventory -4, min (0), max (40) higher score indicate more severe symptoms

  Measuring pain symptoms

  Baseline

• Brief Pain Inventory -4, min (0), max (40) higher score indicate more severe symptoms

  Measuring pain symptoms

  Post-intervention (10 weeks from start)

• Brief Pain Inventory -4, min (0), max (40) higher score indicate more severe symptoms

  Measuring pain symptoms

  FU at 4 months.

• Brief Pain Inventory -4, min (0), max (40) higher score indicate more severe symptoms

  Measuring pain symptoms

  FU at 12 months.

Secondary Outcomes (32)

• Generalized Anxiety Disorder-7, min (0), max (21), higher score indicate more severe symptoms

  Baseline

• Generalized Anxiety Disorder-7, min (0), max (21), higher score indicate more severe symptoms

  Post-intervention (10 weeks from start)

• Generalized Anxiety Disorder-7, min (0), max (21), higher score indicate more severe symptoms

  FU at 4 month

• Generalized Anxiety Disorder-7, min (0), max (21), higher score indicate more severe symptoms

  FU at 12 month

• Patient Health Questionnaire-9, min (0), max (27), higher score indicate more severe symptoms

  Baseline

Other Outcomes (5)

• Process measure: Generalized Anxiety Disorder-2, min (0), max (6), higher score indicates more pronounced symptoms

  During treatment: Once every week for 10 weeks

• Process measure: Patient Health Questionnaire-2, min (0), max (6), higher score indicates more pronounced symptoms

  During treatment: Once every week for 10 weeks

• Process measure: Emotional Processing Scale-25, min (0), max (225), higher score indicates more pronounced difficulties with emotional processing capacity

  During treatment: Once every week for 10 weeks

Study Arms (2)

I-EAET

EXPERIMENTAL

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

WL

NO INTERVENTION

Wait-list.

Interventions

I-EAET BEHAVIORAL

See information in arm description.

I-EAET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Stockholm University: collaborator
• Wayne State University: collaborator

Study Sites (1)

Karolinska Institute

Stockholm, 17177, Sweden

Location

Related Publications (15)

• Budtz-Lilly A, Vestergaard M, Fink P, Carlsen AH, Rosendal M. The prognosis of bodily distress syndrome: a cohort study in primary care. Gen Hosp Psychiatry. 2015 Nov-Dec;37(6):560-6. doi: 10.1016/j.genhosppsych.2015.08.002. Epub 2015 Aug 20.

  PMID: 26371705 BACKGROUND

• den Boeft M, Twisk JW, Terluin B, Penninx BW, van Marwijk HW, Numans ME, van der Wouden JC, van der Horst HE. The association between medically unexplained physical symptoms and health care use over two years and the influence of depressive and anxiety disorders and personality traits: a longitudinal study. BMC Health Serv Res. 2016 Mar 22;16:100. doi: 10.1186/s12913-016-1332-7.

  PMID: 27125311 BACKGROUND

• Rask MT, Rosendal M, Fenger-Gron M, Bro F, Ornbol E, Fink P. Sick leave and work disability in primary care patients with recent-onset multiple medically unexplained symptoms and persistent somatoform disorders: a 10-year follow-up of the FIP study. Gen Hosp Psychiatry. 2015 Jan-Feb;37(1):53-9. doi: 10.1016/j.genhosppsych.2014.10.007. Epub 2014 Oct 22.

  PMID: 25456975 BACKGROUND

• van Dessel N, den Boeft M, van der Wouden JC, Kleinstauber M, Leone SS, Terluin B, Numans ME, van der Horst HE, van Marwijk H. Non-pharmacological interventions for somatoform disorders and medically unexplained physical symptoms (MUPS) in adults. Cochrane Database Syst Rev. 2014 Nov 1;2014(11):CD011142. doi: 10.1002/14651858.CD011142.pub2.

  PMID: 25362239 BACKGROUND

• Beck T, Breuss M, Kumnig M, Schussler G. The first step is the hardest - emotion recognition in patients with somatoform disorders. Z Psychosom Med Psychother. 2013;59(4):385-90. doi: 10.13109/zptm.2013.59.4.385.

  PMID: 24307338 BACKGROUND

• Farnam A, Somi MH, Farhang S, Mahdavi N, Ali Besharat M. The therapeutic effect of adding emotional awareness training to standard medical treatment for irritable bowel syndrome: a randomized clinical trial. J Psychiatr Pract. 2014 Jan;20(1):3-11. doi: 10.1097/01.pra.0000442934.38704.3a.

  PMID: 24419306 BACKGROUND

• Coppens E, Van Wambeke P, Morlion B, Weltens N, Giao Ly H, Tack J, Luyten P, Van Oudenhove L. Prevalence and impact of childhood adversities and post-traumatic stress disorder in women with fibromyalgia and chronic widespread pain. Eur J Pain. 2017 Oct;21(9):1582-1590. doi: 10.1002/ejp.1059. Epub 2017 May 24.

  PMID: 28543929 BACKGROUND

• Lumley MA, Schubiner H. Emotional Awareness and Expression Therapy for Chronic Pain: Rationale, Principles and Techniques, Evidence, and Critical Review. Curr Rheumatol Rep. 2019 May 23;21(7):30. doi: 10.1007/s11926-019-0829-6.

  PMID: 31123837 BACKGROUND

• Yarns BC, Lumley MA, Cassidy JT, Steers WN, Osato S, Schubiner H, Sultzer DL. Emotional Awareness and Expression Therapy Achieves Greater Pain Reduction than Cognitive Behavioral Therapy in Older Adults with Chronic Musculoskeletal Pain: A Preliminary Randomized Comparison Trial. Pain Med. 2020 Nov 1;21(11):2811-2822. doi: 10.1093/pm/pnaa145.

  PMID: 32451528 BACKGROUND

• Lumley MA, Schubiner H, Lockhart NA, Kidwell KM, Harte SE, Clauw DJ, Williams DA. Emotional awareness and expression therapy, cognitive behavioral therapy, and education for fibromyalgia: a cluster-randomized controlled trial. Pain. 2017 Dec;158(12):2354-2363. doi: 10.1097/j.pain.0000000000001036.

  PMID: 28796118 BACKGROUND

• Andersson G. Internet-Delivered Psychological Treatments. Annu Rev Clin Psychol. 2016;12:157-79. doi: 10.1146/annurev-clinpsy-021815-093006. Epub 2015 Dec 11.

  PMID: 26652054 BACKGROUND

• Johansson R, Bjorklund M, Hornborg C, Karlsson S, Hesser H, Ljotsson B, Rousseau A, Frederick RJ, Andersson G. Affect-focused psychodynamic psychotherapy for depression and anxiety through the Internet: a randomized controlled trial. PeerJ. 2013 Jul 9;1:e102. doi: 10.7717/peerj.102. Print 2013.

  PMID: 23862104 BACKGROUND

• Johansson R, Hesslow T, Ljotsson B, Jansson A, Jonsson L, Fardig S, Karlsson J, Hesser H, Frederick RJ, Lilliengren P, Carlbring P, Andersson G. Internet-based affect-focused psychodynamic therapy for social anxiety disorder: A randomized controlled trial with 2-year follow-up. Psychotherapy (Chic). 2017 Dec;54(4):351-360. doi: 10.1037/pst0000147.

  PMID: 29251954 BACKGROUND

• Schubiner H, Betzold M. Unlearn your pain : a 28-day process to reprogram your brain. Pleasant Ridge, MI: Mind Body Publishing; 2012.

  BACKGROUND

• Maroti D, Lumley MA, Schubiner H, Lilliengren P, Bileviciute-Ljungar I, Ljotsson B, Johansson R. Internet-based emotional awareness and expression therapy for somatic symptom disorder: A randomized controlled trial. J Psychosom Res. 2022 Dec;163:111068. doi: 10.1016/j.jpsychores.2022.111068. Epub 2022 Oct 22.

  PMID: 36327532 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Pain; Wounds and Injuries

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Johansson, PhD

  Karolinska Insitutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: RCT with Wait-List condition

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 12, 2021
• Study Start: February 1, 2021
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2022
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

SE (1)