Somatic Symptom DisorderMBS1NCT04122846
Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder
A study testing Emotional Awareness and Expression Therapy in people with Somatic Symptom Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Somatic Symptom Disorder
- What is being tested?
- Emotional Awareness and Expression Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 30 Sep 2019to 1 Apr 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Somatic Symptom Disorder
- Being tested
- Emotional Awareness and Expression Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Awareness and Expression TherapyBehavioural
Very much based on "Unlearn your pain" by Howard Schubiner.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (Emotional Awareness and Expression Therapy) | Experimental | Internet-based Emotional Awareness and Expression Therapy Receives: Behavioral: Emotional Awareness and Expression Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PHQ-15
Patient Health Questionnaire Physical Symptoms
Measured: Baseline
PHQ-15
Change in physical symptoms (as measured by the PHQ-15)
Measured: Weekly during treatment, for 9 weeks
PHQ-15
Patient Health Questionnaire Physical Symptoms
Measured: At study completion, after 9 weeks
PHQ-15
Patient Health Questionnaire Physical Symptoms
Measured: At study completion, after 4 months
Secondary outcomes (9)
PHQ-9
Patient Health Questionnaire Depression
Measured: Baseline
PHQ-9
Patient Health Questionnaire Depression
Measured: At study completion, after 9 weeks
PHQ-9
Patient Health Questionnaire Depression
Measured: At study completion, after 4 months
GAD-7
Patient Health Questionnaire Anxiety
Measured: Baseline
GAD-7
Patient Health Questionnaire Anxiety
Measured: At study completion, after 9 weeks
GAD-7
Patient Health Questionnaire Anxiety
Measured: At study completion, after 4 months
SDS
Sheehan Disability Scale
Measured: Baseline
SDS
Sheehan Disability Scale
Measured: At study completion, after 9 weeks
SDS
Sheehan Disability Scale
Measured: At study completion, after 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start30 Sep 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Model description
- Emotional Awareness and Expression Therapy
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm University
- Responsible party
- Principal investigator, Robert Johansson, Karolinska Institutet
- Investigators
- Robert Johansson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122846
- Sponsor's protocol ID
- KIMBS1
- Acronym
- MBS1
- Status last verified
- Apr 2020
- First submitted
- 4 Oct 2019
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. 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
- ClinicalTrials.gov ID
- NCT04122846
- Acronym / sponsor ID
- MBS1 / KIMBS1
- Conditions
- Somatic Symptom Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Stockholm University
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 10 Oct 2019 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Emotional Awareness and Expression Therapy
| Arm | Type | Receives |
|---|---|---|
| Treatment (Emotional Awareness and Expression Therapy) | Experimental | Behavioral: Emotional Awareness and Expression TherapyInternet-based Emotional Awareness and Expression Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
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 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
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 |
|---|---|---|
| Emotional Awareness and Expression TherapyVery much based on "Unlearn your pain" by Howard Schubiner. | Behavioural | Treatment (Emotional Awareness and Expression Therapy) |
Primary outcome
PHQ-15
Time frame: Baseline
Patient Health Questionnaire Physical Symptoms
PHQ-15
Time frame: Weekly during treatment, for 9 weeks
Change in physical symptoms (as measured by the PHQ-15)
PHQ-15
Time frame: At study completion, after 9 weeks
Patient Health Questionnaire Physical Symptoms
PHQ-15
Time frame: At study completion, after 4 months
Patient Health Questionnaire Physical Symptoms
9 secondary outcomes
PHQ-9
Time frame: Baseline
PHQ-9
Time frame: At study completion, after 9 weeks
PHQ-9
Time frame: At study completion, after 4 months
GAD-7
Time frame: Baseline
GAD-7
Time frame: At study completion, after 9 weeks
GAD-7
Time frame: At study completion, after 4 months
SDS
Time frame: Baseline
SDS
Time frame: At study completion, after 9 weeks
SDS
Time frame: At study completion, after 4 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 16 Apr 2020.
- Derived from this study: PubMed 33679478Maroti 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.
- Individual participant dataSharing planned: No
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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 Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Awareness and Expression Therapy 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 16 Apr 2020. 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?
PHQ-15 (time frame: Baseline). The study lists 4 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 NCT04122846, which also lists 1 linked publication.
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 16 Apr 2020.