Clinical trial NCT04122846: Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder
Official title: Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Somatic Symptom Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Stockholm University
First posted: 2019-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Emotional Awareness and Expression Therapy
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

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

Primary outcomes:
measure: PHQ-15
timeFrame: Baseline
measure: PHQ-15
timeFrame: Weekly during treatment, for 9 weeks
measure: PHQ-15
timeFrame: At study completion, after 9 weeks
measure: PHQ-15
timeFrame: At study completion, after 4 months
Secondary outcomes:
measure: PHQ-9
timeFrame: Baseline
measure: PHQ-9
timeFrame: At study completion, after 9 weeks
measure: PHQ-9
timeFrame: At study completion, after 4 months
measure: GAD-7
timeFrame: Baseline
measure: GAD-7
timeFrame: At study completion, after 9 weeks
measure: GAD-7
timeFrame: At study completion, after 4 months
measure: SDS
timeFrame: Baseline
measure: SDS
timeFrame: At study completion, after 9 weeks
measure: SDS
timeFrame: At study completion, after 4 months
Other outcomes:
measure: EPS-25
timeFrame: Baseline
measure: EPS-25
timeFrame: Weekly during treatment, for 9 weeks
measure: EPS-25
timeFrame: At study completion, after 9 weeks
measure: EPS-25
timeFrame: At study completion, after 4 months
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Robert Johansson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.