Somatic Symptom DisorderMBS2NCT04751825
Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder - A Randomized Controlled Trial
A study testing I-EAET in people with Somatic Symptom Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Somatic Symptom Disorder
- What is being tested?
- I-EAET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2021to 15 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Research background Somatic Symptom Disorder (SSD; DSM-5) is one of the most prevalent disorders encountered in primary care settings (1). Typically in SSD, distressing somatic complaints are accompanied by abnormal thoughts, feelings, and behaviors, emphasizing the role of psychological factors. The experience of somatic symptoms is commonly associated with high levels of impairment in quality of life, psychological distress or increased healthcare utilization (2). In addition, SSD has been associated with an elevated risk for chronic manifestation and comorbid mental disorders, work loss or early retirement (3). Although cognitive behavior therapy (CBT) is the best evidenced psychological treatment for SSD, effect sizes are rather moderate or even small (4). Therefore the question of how to develop more effective treatment protocols for SSD arises.
Difficulties in emotional processing and expression have been demonstrated with patients with SSD in several studies (5). Importantly though, there are indications that an emotion focus in treatment increases the possibility of symptom reduction for patients with SSD (6). In addition, many patients with SSD have experienced stressful/traumatic life events (7). Hence, another potential reason for the limited effect of CBT for SSD may be that these traumas have not been adequately addressed in treatment.
Emotional Awareness and Expression Therapy (EAET) is an affect-focused psychodynamic form of psychotherapy, that has an explicit focus on emotional processing and resolving attachment trauma (8). There is a promising research support for EAET for treating SSD related disorders, where it has been shown to be more effective than CBT in two randomized controlled trials where fibromyalgia and chronic musculoskeletal pain were targeted, respectively (9,10).
Many of today's models of psychotherapy has been tested as guided self-help via the Internet (11). This is a cost-effective, scalable form of psychotherapy delivery. While there exists promising evidence that Internet-based affect-focused psychodynamic therapy is effective in the treatment of depression and anxiety disorders (12,13), there are no published studies on EAET in the format of guided self-help delivered via the Internet.
Preliminary results from a pilot study on Internet-based EAET However, our own group very recently completed a (yet unpublished) pilot trial of Internet based EAET (I-EAET), with an explicit focus on emotional processing using expressive writing. The project was approved by the Swedish Ethical Review Authority (Dnr 2019-03317). We included 52 patients with SSD who took part of a nine-week program based on EAET. Details of the I-EAET intervention are described in the Methods sections below. A large within-group reduction in somatic symptoms (PHQ-15) was observed (Cohen's d = 1.12; 95% CI: 0.77-1.46). Small to moderate magnitude reductions in anxiety (GAD-7), depression (PHQ-9), trauma related symptoms (PCL-5), and dysfunctional emotional processing (EPS25) occurred. Almost one-quarter of the sample (23.1%) achieved a 50% or greater reduction in somatic symptoms. The treatment also significantly increased patient's ability to take part in social and family life (Sheehan Disability Scale). The results were maintained at a four month follow-up. While the results are to be interpreted carefully, the effects seem promising. Further research studies on I-EAET using randomized controlled trials are warranted.
This research proposal is about testing the effects of I-EAET in the treatment of SSD, compared to a waiting-list control condition, using a randomized controlled trial. The long term goal is to develop an intervention that can increase treatment optimization in SSD.
Research questions
- Can Internet-delivered EAET with an explicit focus on expressive writing decrease bodily symptoms and pain, depression, anxiety and insomnia symptoms, among patients with SSD, as compared to a control condition? b) Is symptom reduction throughout treatment of SSD associated with an increase in emotional processing? c) Are the effects maintained at a 4-month- and 12-month follow-up?
Methods The I-EAET intervention was developed as part of the pilot trial, conducted during late 2019. It is primarily based on Howard Schubiner's book "Unlearn your pain" (14). The I-EAET intervention includes 1) a psychoeducational component on the brain and the nervous system, 2) self-compassion training using meditation techniques, 3) awareness practice on the relationship between trauma, emotions and bodily symptoms, 4) emotional processing using expressive writing exercises, and 5) adaptive interpersonal communication in situations that might trigger pain symptoms. The treatment will last 10 weeks. A secure web-platform (the KI e-Health Core Facility) will be used to provide the treatment via the Internet. Every week the participant in the treatment reads a text consisting of 10-20 pages. The text specifies the theme for the week (i.e. self-compassion) and the home-work assignments to be conducted during the week. Typically, the participants do a daily meditation exercise for 10-15 minutes and an expressive writing assignment for 15-30 minutes. In the daily meditation exercises the participant learn to observe self-critical thoughts and to notice that these thoughts sometimes is anger turned at oneself. Using these meditation exercises, the participants learns to develop a compassionate voice instead of their self-critical one. In the written assignments, usually a stressful or traumatic life event is targeted where emotions are processed in a prespecified order. Emotions tied to these situations are often anger, guilt about anger, sadness and love.
When the participants have done the homework for the week, they send it to their designated psychologist and get written feedback.
Randomized controlled trial of Internet-based EAET for SSD 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.
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.
Time plan January 2021: Recruitment, screening procedure and diagnostic interviews February 2021: Treatment start + Pre-treatment measures conducted April 2021: Treatment ends + Post-treatment measures conducted September 2021: Four-month follow-up + Treatment offered to patients on waiting-list April 2022: Twelve-month follow-up measures
Significance An EAET intervention conducted through the Internet, with a strong focus on emotional processing using expressive writing could potentially increase treatment optimization in SSD and offer a new potential treatment avenue. Furthermore, although several theoretical models of SSD exist, the field lacks solid empirical results from treatment trials, where the analyses of mechanisms of change are conducted using state-of-the-art methods. Such analyses could help to pinpoint the relation between symptom change and emotional processing throughout different phases of treatment.
Ethical considerations Given that the treatment manual in our studies has not been evaluated before, special considerations will be given to adverse effects. As weekly symptom measures will be conducted, we will be able to monitor patients closely for any potential deterioration that will need to be handled. Medical experts will be available for consultation throughout the treatment periods. Adverse events of treatment will also be monitored by using the Negative Effects Questionnaire (NEQ).
- Conditions
- Somatic Symptom Disorder
- Being tested
- I-EAET
- Keywords
- Emotional Awareness and Expression Therapy, Somatic symptom disorder, Central sensitisation, Fibromyalgia, Pain, Self-help, Emotional processing, Trauma
- Medical subject headings
- Fibromyalgia, Pain, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-EAETBehavioural
See information in arm description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: I-EAET |
| WL | No intervention | Wait-list. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-15. Min (0), Max (30), higher score indicate more somatic symptoms
Measuring somatic symptoms
Measured: Baseline
Patient Health Questionnaire-15. Min (0), Max (30), higher score indicate more somatic symptoms
Measuring somatic symptoms
Measured: Post-intervention (10 weeks from start)
Patient Health Questionnaire-15. Min (0), Max (30), higher score indicate more somatic symptoms
Measuring somatic symptoms
Measured: FU at 4 months
Patient Health Questionnaire-15. Min (0), Max (30), higher score indicate more somatic symptoms
Measuring somatic symptoms
Measured: FU at 12 months
Brief Pain Inventory -4, min (0), max (40) higher score indicate more severe symptoms
Measuring pain symptoms
Measured: Baseline
Brief Pain Inventory -4, min (0), max (40) higher score indicate more severe symptoms
Measuring pain symptoms
Measured: Post-intervention (10 weeks from start)
Brief Pain Inventory -4, min (0), max (40) higher score indicate more severe symptoms
Measuring pain symptoms
Measured: FU at 4 months.
Brief Pain Inventory -4, min (0), max (40) higher score indicate more severe symptoms
Measuring pain symptoms
Measured: FU at 12 months.
Secondary outcomes (32)
Generalized Anxiety Disorder-7, min (0), max (21), higher score indicate more severe symptoms
Measuring anxiety symptoms
Measured: Baseline
Generalized Anxiety Disorder-7, min (0), max (21), higher score indicate more severe symptoms
Measuring anxiety symptoms
Measured: Post-intervention (10 weeks from start)
Generalized Anxiety Disorder-7, min (0), max (21), higher score indicate more severe symptoms
Measuring anxiety symptoms
Measured: FU at 4 month
Generalized Anxiety Disorder-7, min (0), max (21), higher score indicate more severe symptoms
Measuring anxiety symptoms
Measured: FU at 12 month
Patient Health Questionnaire-9, min (0), max (27), higher score indicate more severe symptoms
Measuring depressive symptoms
Measured: Baseline
Patient Health Questionnaire-9, min (0), max (27), higher score indicate more severe symptoms
Measuring depressive symptoms
Measured: Post-intervention (10 weeks from start)
Patient Health Questionnaire-9, min (0), max (27), higher score indicate more severe symptoms
Measuring depressive symptoms
Measured: FU at 4 month
Patient Health Questionnaire-9, min (0), max (27), higher score indicate more severe symptoms
Measuring depressive symptoms
Measured: FU at 12 month
Post-traumatic Stress Disorder CheckList-5, min (0), max (80), higher score indicate more severe symptoms
Measuring post traumatic symptoms
Measured: Baseline
Post-traumatic Stress Disorder CheckList-5, min (0), max (80), higher score indicate more severe symptoms
Measuring post traumatic symptoms
Measured: Post-intervention (10 weeks from start)
Post-traumatic Stress Disorder CheckList-5, min (0), max (80), higher score indicate more severe symptoms
Measuring post traumatic symptoms
Measured: FU at 4 month
Post-traumatic Stress Disorder CheckList-5, min (0), max (80), higher score indicate more severe symptoms
Measuring post traumatic symptoms
Measured: FU at 12 month
Shehan Disability Scale (SDS), min (0), max (30), higher score indicate more severe disability
Measuring activity level in three domains (social, work and leisure time)
Measured: Baseline
Shehan Disability Scale (SDS), min (0), max (30), higher score indicate more severe disability
Measuring activity level in three domains (social, work and leisure time)
Measured: Post-intervention (10 weeks from start)
Shehan Disability Scale (SDS), min (0), max (30), higher score indicate more severe disability
Measuring activity level in three domains (social, work and leisure time)
Measured: FU at 4 month
Shehan Disability Scale (SDS), min (0), max (30), higher score indicate more severe disability
Measuring activity level in three domains (social, work and leisure time)
Measured: FU at 12 month
Epworth Sleepiness Scale, min (0), max (24) higher score indicate more severe symptoms
Measuring sleepiness symptoms from
Measured: Baseline
Epworth Sleepiness Scale, min (0), max (24) higher score indicate more severe symptoms
Measuring sleepiness symptoms from
Measured: Post-intervention (10 weeks from start)
Epworth Sleepiness Scale, min (0), max (24) higher score indicate more severe symptoms
Measuring sleepiness symptoms from
Measured: FU at 4 month
Epworth Sleepiness Scale, min (0), max (24) higher score indicate more severe symptoms
Measuring sleepiness symptoms from
Measured: FU at 12 month
Insomnia Severy Index, min (0), max (21), higher score indicate more severe symptoms
Measuring insomnia symptoms
Measured: Baseline
Insomnia Severy Index, min (0), max (21), higher score indicate more severe symptoms
Measuring insomnia symptoms
Measured: Post-intervention (10 weeks from start)
Insomnia Severy Index, min (0), max (21), higher score indicate more severe symptoms
Measuring insomnia symptoms
Measured: FU at 4 month
Insomnia Severy Index, min (0), max (21), higher score indicate more severe symptoms
Measuring insomnia symptoms
Measured: FU at 12 month
Negative Effects Questionnaire, min (0), max (128), higher score indicate more severe negative effects
Measuring Negative Effects
Measured: Post-intervention (10 weeks from start)
Negative Effects Questionnaire, min (0), max (128), higher score indicate more severe negative effects
Measuring Negative Effects
Measured: FU at 12 months
Level of Emotional Awareness Scale, min (0), max (100), higher score indicate better emotional awareness capacity
Measuring emotional awareness capacity
Measured: Baseline
Level of Emotional Awareness Scale, min (0), max (100), higher score indicate better emotional awareness capacity
Measuring emotional awareness capacity
Measured: FU 4 month
Emotional Processing Scale-25, min (0), max (225), higher score indicates more pronounced difficulties with emotional processing capacity
Measuring emotional processing capacity
Measured: Baseline
Emotional Processing Scale-25, min (0), max (225), higher score indicates more pronounced difficulties with emotional processing capacity
Measuring emotional processing capacity
Measured: Post-intervention (10 weeks from start)
Emotional Processing Scale-25, min (0), max (225), higher score indicates more pronounced difficulties with emotional processing capacity
Measuring emotional processing capacity
Measured: FU 4 month
Emotional Processing Scale-25, min (0), max (225), higher score indicates more pronounced difficulties with emotional processing capacity
Measuring emotional processing capacity
Measured: FU at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start1 Feb 2021
- Primary completion15 Apr 2021
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Somatic Symptom DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT with Wait-List condition
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm University, Wayne State University
- Responsible party
- Principal investigator, Robert Johansson, Karolinska Institutet
- Investigators
- Robert Johansson, PhD, Principal investigator, Karolinska Insitutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751825
- Sponsor's protocol ID
- KIMBS2
- Acronym
- MBS2
- Status last verified
- Jun 2022
- First submitted
- 1 Feb 2021
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26371705den 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.
PubMed 27125311Rask 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.
PubMed 25456975van 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.
PubMed 25362239Beck 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.
PubMed 24307338Farnam 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.
PubMed 24419306Coppens 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.
PubMed 28543929Lumley 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.
PubMed 31123837Yarns 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.
PubMed 32451528Lumley 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.
PubMed 28796118Andersson G. Internet-Delivered Psychological Treatments. Annu Rev Clin Psychol. 2016;12:157-79. doi: 10.1146/annurev-clinpsy-021815-093006. Epub 2015 Dec 11.
PubMed 26652054Johansson 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.
PubMed 23862104Johansson 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.
PubMed 29251954Schubiner H, Betzold M. Unlearn your pain : a 28-day process to reprogram your brain. Pleasant Ridge, MI: Mind Body Publishing; 2012.
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.
PubMed 36327532
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04751825
- Acronym / sponsor ID
- MBS2 / KIMBS2
- Conditions
- Somatic Symptom Disorder
- Keywords
- Emotional Awareness and Expression Therapy, Somatic symptom disorder, Central sensitisation, Fibromyalgia, Pain, Self-help, Emotional processing, Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Stockholm University, Wayne State University
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research background Somatic Symptom Disorder (SSD; DSM-5) is one of the most prevalent disorders encountered in primary care settings (1). Typically in SSD, distressing somatic complaints are accompanied by abnormal thoughts, feelings, and behaviors, emphasizing the role of psychological factors. The experience of somatic symptoms is commonly associated with high levels of impairment in quality of life, psychological distress or increased healthcare utilization (2). In addition, SSD has been associated with an elevated risk for chronic manifestation and comorbid mental disorders, work loss or early retirement (3). Although cognitive behavior therapy (CBT) is the best evidenced psychological treatment for SSD, effect sizes are rather moderate or even small (4). Therefore the question of how to develop more effective treatment protocols for SSD arises.
Difficulties in emotional processing and expression have been demonstrated with patients with SSD in several studies (5). Importantly though, there are indications that an emotion focus in treatment increases the possibility of symptom reduction for patients with SSD (6). In addition, many patients with SSD have experienced stressful/traumatic life events (7). Hence, another potential reason for the limited effect of CBT for SSD may be that these traumas have not been adequately addressed in treatment.
Emotional Awareness and Expression Therapy (EAET) is an affect-focused psychodynamic form of psychotherapy, that has an explicit focus on emotional processing and resolving attachment trauma (8). There is a promising research support for EAET for treating SSD related disorders, where it has been shown to be more effective than CBT in two randomized controlled trials where fibromyalgia and chronic musculoskeletal pain were targeted, respectively (9,10).
Many of today's models of psychotherapy has been tested as guided self-help via the Internet (11). This is a cost-effective, scalable form of psychotherapy delivery. While there exists promising evidence that Internet-based affect-focused psychodynamic therapy is effective in the treatment of depression and anxiety disorders (12,13), there are no published studies on EAET in the format of guided self-help delivered via the Internet.
Preliminary results from a pilot study on Internet-based EAET However, our own group very recently completed a (yet unpublished) pilot trial of Internet based EAET (I-EAET), with an explicit focus on emotional processing using expressive writing. The project was approved by the Swedish Ethical Review Authority (Dnr 2019-03317). We included 52 patients with SSD who took part of a nine-week program based on EAET. Details of the I-EAET intervention are described in the Methods sections below. A large within-group reduction in somatic symptoms (PHQ-15) was observed (Cohen's d = 1.12; 95% CI: 0.77-1.46). Small to moderate magnitude reductions in anxiety (GAD-7), depression (PHQ-9), trauma related symptoms (PCL-5), and dysfunctional emotional processing (EPS25) occurred. Almost one-quarter of the sample (23.1%) achieved a 50% or greater reduction in somatic symptoms. The treatment also significantly increased patient's ability to take part in social and family life (Sheehan Disability Scale). The results were maintained at a four month follow-up. While the results are to be interpreted carefully, the effects seem promising. Further research studies on I-EAET using randomized controlled trials are warranted.
This research proposal is about testing the effects of I-EAET in the treatment of SSD, compared to a waiting-list control condition, using a randomized controlled trial. The long term goal is to develop an intervention that can increase treatment optimization in SSD.
Research questions
- Can Internet-delivered EAET with an explicit focus on expressive writing decrease bodily symptoms and pain, depression, anxiety and insomnia symptoms, among patients with SSD, as compared to a control condition? b) Is symptom reduction throughout treatment of SSD associated with an increase in emotional processing? c) Are the effects maintained at a 4-month- and 12-month follow-up?
Methods The I-EAET intervention was developed as part of the pilot trial, conducted during late 2019. It is primarily based on Howard Schubiner's book "Unlearn your pain" (14). The I-EAET intervention includes 1) a psychoeducational component on the brain and the nervous system, 2) self-compassion training using meditation techniques, 3) awareness practice on the relationship between trauma, emotions and bodily symptoms, 4) emotional processing using expressive writing exercises, and 5) adaptive interpersonal communication in situations that might trigger pain symptoms. The treatment will last 10 weeks. A secure web-platform (the KI e-Health Core Facility) will be used to provide the treatment via the Internet. Every week the participant in the treatment reads a text consisting of 10-20 pages. The text specifies the theme for the week (i.e. self-compassion) and the home-work assignments to be conducted during the week. Typically, the participants do a daily meditation exercise for 10-15 minutes and an expressive writing assignment for 15-30 minutes. In the daily meditation exercises the participant learn to observe self-critical thoughts and to notice that these thoughts sometimes is anger turned at oneself. Using these meditation exercises, the participants learns to develop a compassionate voice instead of their self-critical one. In the written assignments, usually a stressful or traumatic life event is targeted where emotions are processed in a prespecified order. Emotions tied to these situations are often anger, guilt about anger, sadness and love.
When the participants have done the homework for the week, they send it to their designated psychologist and get written feedback.
Randomized controlled trial of Internet-based EAET for SSD 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.
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.
Time plan January 2021: Recruitment, screening procedure and diagnostic interviews February 2021: Treatment start + Pre-treatment measures conducted April 2021: Treatment ends + Post-treatment measures conducted September 2021: Four-month follow-up + Treatment offered to patients on waiting-list April 2022: Twelve-month follow-up measures
Significance An EAET intervention conducted through the Internet, with a strong focus on emotional processing using expressive writing could potentially increase treatment optimization in SSD and offer a new potential treatment avenue. Furthermore, although several theoretical models of SSD exist, the field lacks solid empirical results from treatment trials, where the analyses of mechanisms of change are conducted using state-of-the-art methods. Such analyses could help to pinpoint the relation between symptom change and emotional processing throughout different phases of treatment.
Ethical considerations Given that the treatment manual in our studies has not been evaluated before, special considerations will be given to adverse effects. As weekly symptom measures will be conducted, we will be able to monitor patients closely for any potential deterioration that will need to be handled. Medical experts will be available for consultation throughout the treatment periods. Adverse events of treatment will also be monitored by using the Negative Effects Questionnaire (NEQ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT with Wait-List condition
| Arm | Type | Receives |
|---|---|---|
| I-EAET | Experimental | Behavioral: I-EAETInternet 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. |
| WL | No intervention | –Wait-list. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-EAETSee information in arm description. | Behavioural | I-EAET |
Primary outcome
Patient Health Questionnaire-15. Min (0), Max (30), higher score indicate more somatic symptoms
Time frame: Baseline
Measuring somatic symptoms
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
Patient Health Questionnaire-15. Min (0), Max (30), higher score indicate more somatic symptoms
Time frame: FU at 4 months
Measuring somatic symptoms
Patient Health Questionnaire-15. Min (0), Max (30), higher score indicate more somatic symptoms
Time frame: FU at 12 months
Measuring somatic symptoms
Brief Pain Inventory -4, min (0), max (40) higher score indicate more severe symptoms
Time frame: Baseline
Measuring pain symptoms
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
Brief Pain Inventory -4, min (0), max (40) higher score indicate more severe symptoms
Time frame: FU at 4 months.
Measuring pain symptoms
Brief Pain Inventory -4, min (0), max (40) higher score indicate more severe symptoms
Time frame: FU at 12 months.
Measuring pain symptoms
32 secondary outcomes
Generalized Anxiety Disorder-7, min (0), max (21), higher score indicate more severe symptoms
Time frame: Baseline
Generalized Anxiety Disorder-7, min (0), max (21), higher score indicate more severe symptoms
Time frame: Post-intervention (10 weeks from start)
Generalized Anxiety Disorder-7, min (0), max (21), higher score indicate more severe symptoms
Time frame: FU at 4 month
Generalized Anxiety Disorder-7, min (0), max (21), higher score indicate more severe symptoms
Time frame: FU at 12 month
Patient Health Questionnaire-9, min (0), max (27), higher score indicate more severe symptoms
Time frame: Baseline
Patient Health Questionnaire-9, min (0), max (27), higher score indicate more severe symptoms
Time frame: Post-intervention (10 weeks from start)
Patient Health Questionnaire-9, min (0), max (27), higher score indicate more severe symptoms
Time frame: FU at 4 month
Patient Health Questionnaire-9, min (0), max (27), higher score indicate more severe symptoms
Time frame: FU at 12 month
Post-traumatic Stress Disorder CheckList-5, min (0), max (80), higher score indicate more severe symptoms
Time frame: Baseline
Post-traumatic Stress Disorder CheckList-5, min (0), max (80), higher score indicate more severe symptoms
Time frame: Post-intervention (10 weeks from start)
Post-traumatic Stress Disorder CheckList-5, min (0), max (80), higher score indicate more severe symptoms
Time frame: FU at 4 month
Post-traumatic Stress Disorder CheckList-5, min (0), max (80), higher score indicate more severe symptoms
Time frame: FU at 12 month
Shehan Disability Scale (SDS), min (0), max (30), higher score indicate more severe disability
Time frame: Baseline
Shehan Disability Scale (SDS), min (0), max (30), higher score indicate more severe disability
Time frame: Post-intervention (10 weeks from start)
Shehan Disability Scale (SDS), min (0), max (30), higher score indicate more severe disability
Time frame: FU at 4 month
Shehan Disability Scale (SDS), min (0), max (30), higher score indicate more severe disability
Time frame: FU at 12 month
Epworth Sleepiness Scale, min (0), max (24) higher score indicate more severe symptoms
Time frame: Baseline
Epworth Sleepiness Scale, min (0), max (24) higher score indicate more severe symptoms
Time frame: Post-intervention (10 weeks from start)
Epworth Sleepiness Scale, min (0), max (24) higher score indicate more severe symptoms
Time frame: FU at 4 month
Epworth Sleepiness Scale, min (0), max (24) higher score indicate more severe symptoms
Time frame: FU at 12 month
Insomnia Severy Index, min (0), max (21), higher score indicate more severe symptoms
Time frame: Baseline
Insomnia Severy Index, min (0), max (21), higher score indicate more severe symptoms
Time frame: Post-intervention (10 weeks from start)
Insomnia Severy Index, min (0), max (21), higher score indicate more severe symptoms
Time frame: FU at 4 month
Insomnia Severy Index, min (0), max (21), higher score indicate more severe symptoms
Time frame: FU at 12 month
Negative Effects Questionnaire, min (0), max (128), higher score indicate more severe negative effects
Time frame: Post-intervention (10 weeks from start)
Negative Effects Questionnaire, min (0), max (128), higher score indicate more severe negative effects
Time frame: FU at 12 months
Level of Emotional Awareness Scale, min (0), max (100), higher score indicate better emotional awareness capacity
Time frame: Baseline
Level of Emotional Awareness Scale, min (0), max (100), higher score indicate better emotional awareness capacity
Time frame: FU 4 month
Emotional Processing Scale-25, min (0), max (225), higher score indicates more pronounced difficulties with emotional processing capacity
Time frame: Baseline
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)
Emotional Processing Scale-25, min (0), max (225), higher score indicates more pronounced difficulties with emotional processing capacity
Time frame: FU 4 month
Emotional Processing Scale-25, min (0), max (225), higher score indicates more pronounced difficulties with emotional processing capacity
Time frame: FU at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Background: PubMed 26371705Budtz-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.
- Background: PubMed 27125311den 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.
- Background: PubMed 25456975Rask 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.
- Background: PubMed 25362239van 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.
- Background: PubMed 24307338Beck 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.
- Background: PubMed 24419306Farnam 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.
- Background: PubMed 28543929Coppens 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.
- Background: PubMed 31123837Lumley 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.
- Background: PubMed 32451528Yarns 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.
- Background: PubMed 28796118Lumley 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.
- Background: PubMed 26652054Andersson G. Internet-Delivered Psychological Treatments. Annu Rev Clin Psychol. 2016;12:157-79. doi: 10.1146/annurev-clinpsy-021815-093006. Epub 2015 Dec 11.
- Background: PubMed 23862104Johansson 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.
Related trials for Somatic Symptom Disorder
RecruitingObservational study
Precision-Based Genomics in Prostate Cancer
Prostate Cancer
Active, not recruiting
Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms
Safety, Psychological, Acceptability of Health Care
RecruitingPhase 2
A 52-Week Study Evaluating the Efficacy and Safety of Arumakimig (MAS825) in Participants With VEXAS Followed by Open-Label Extension (OLE) Period
VEXAS Syndrome
Recruiting
Stress Management and Meditative Movements for Asian Americans With Depression and Physical Symptoms
Depression / Major Depressive Disorder, Mental Health (Depression)
Recruiting
Ultra-brief Psychological Treatments for Emotional Symptoms and Disorders
Depression - Major Depressive Disorder, Generalized Anxiety Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Johansson, PhD principal investigator
Karolinska Insitutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-EAET in people with Somatic Symptom Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-15. Min (0), Max (30), higher score indicate more somatic symptoms (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04751825, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.