ClinicalTrials.gg
CompletedNCT04122846MBS1Updated Apr 16, 2020

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

An interventional study of Emotional Awareness and Expression Therapy in Somatic Symptom Disorder, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-16.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Medically Unexplained Symptoms with a site in Sweden — 1 open to participants now, 1 under way, none of them phase 3. Medically Unexplained Symptoms · Sweden.

Enrollment
8th of 13
50 · median 120
Started
2019
the only one that year
No phase
13 of 13
1 open now
Registered
4th of 13
by date
Lead sponsor
5 of 13
Karolinska Institutet

Among the 13 studies in Medically Unexplained Symptoms with a site in Sweden, this one is the 8th largest by enrollment, is the only one that started in 2019, is one of 13 with no phase, and was the 4th registered.

Medically Unexplained Symptoms

71 studies on the registry are indexed under Medically Unexplained Symptoms; 22 are open to participants now.

This study's enrollment of 50 is below the median of 68 across 53 interventional studies indexed under Medically Unexplained Symptoms.

Browse Medically Unexplained Symptoms studies →

Open to participants now

1 of the 13 studies in Medically Unexplained Symptoms with a site in Sweden is open now, in 1 country. Each count lists the studies.

Where they have run

Who these studies take

Of the 20 Medically Unexplained Symptoms studies recruiting now, 6 (30%) set no upper age limit and 12 (60%) stop at 75 or younger; 6 take children under 18; 9 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Medically Unexplained Symptoms with a site in Sweden, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Somatic Symptom Disorder
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age over 18 years
  • A total score ≥10 on the PHQ-15
  • A diagnosis of SSD according to the , 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Treatment (Emotional Awareness and Expression Therapy)

    Internet-based Emotional Awareness and Expression Therapy

    Behavioral: Emotional Awareness and Expression Therapy

Interventions

  • BehavioralEmotional Awareness and Expression Therapy

    Very much based on "Unlearn your pain" by Howard Schubiner.

06

What researchers measure

Primary outcomes

  1. PHQ-15

    Patient Health Questionnaire Physical Symptoms

    Time frame: Baseline

  2. PHQ-15

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

    Time frame: Weekly during treatment, for 9 weeks

  3. PHQ-15

    Patient Health Questionnaire Physical Symptoms

    Time frame: At study completion, after 9 weeks

  4. PHQ-15

    Patient Health Questionnaire Physical Symptoms

    Time frame: At study completion, after 4 months

Secondary outcomes

  1. PHQ-9

    Patient Health Questionnaire Depression

    Time frame: Baseline

  2. PHQ-9

    Patient Health Questionnaire Depression

    Time frame: At study completion, after 9 weeks

  3. PHQ-9

    Patient Health Questionnaire Depression

    Time frame: At study completion, after 4 months

  4. GAD-7

    Patient Health Questionnaire Anxiety

    Time frame: Baseline

  5. GAD-7

    Patient Health Questionnaire Anxiety

    Time frame: At study completion, after 9 weeks

  6. GAD-7

    Patient Health Questionnaire Anxiety

    Time frame: At study completion, after 4 months

  7. SDS

    Sheehan Disability Scale

    Time frame: Baseline

  8. SDS

    Sheehan Disability Scale

    Time frame: At study completion, after 9 weeks

  9. SDS

    Sheehan Disability Scale

    Time frame: At study completion, after 4 months

Other outcomes

  1. EPS-25

    Emotional Processing Scale (Measure of treatment process)

    Time frame: Baseline

  2. EPS-25

    Emotional Processing Scale (Measure of treatment process)

    Time frame: Weekly during treatment, for 9 weeks

  3. EPS-25

    Emotional Processing Scale (Measure of treatment process)

    Time frame: At study completion, after 9 weeks

  4. EPS-25

    Emotional Processing Scale (Measure of treatment process)

    Time frame: At study completion, after 4 months

07

Study locations

1 site
  • Karolinska Institutet
    Stockholm, Sweden
08

References and documents

Publications

  • Maroti D, Ek J, Widlund RM, Schubiner H, Lumley MA, Lilliengren P, Bileviciute-Ljungar I, Ljotsson B, Johansson R. Internet-Administered Emotional Awareness and Expression Therapy for Somatic Symptom Disorder With Centralized Symptoms: A Preliminary Efficacy Trial. Front Psychiatry. 2021 Feb 12;12:620359. doi: 10.3389/fpsyt.2021.620359. eCollection 2021. PubMed 33679478 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2019 to primary completion in Apr 2020, 6 months.

Of 33 non-industry interventional studies with no phase under Medically Unexplained Symptoms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 6 months is below that.

Counting every sponsor, half of 33 studies reached it within 29 months; a quarter within 10 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2019
First posted
Oct 10, 2019
StartActual
Sep 30, 2019
Primary completionActual
Apr 1, 2020
CompletionActual
Apr 1, 2020
Last update
Apr 16, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04122846
Collaborators
Stockholm University
Responsible party
Robert Johansson (Associate professor, Karolinska Institutet) — Principal investigator
First posted
Oct 10, 2019
Start date
Sep 30, 2019
Primary completion
Apr 1, 2020
Completion
Apr 1, 2020
Last update
Apr 16, 2020

Study contacts

Robert Johansson, PhD
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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