NCT04751825: MBS2

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

Completed NA Last updated 10 June 2022

What this trial tests

NA trial testing I-EAET in Somatic Symptom Disorder in 74 participants. Completed in 15 April 2022.

Timeline

1 February 2021

Primary endpoint
15 April 2021

15 April 2022

Quick facts

Lead sponsor	Karolinska Institutet
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	74
Start date	1 February 2021
Primary completion	15 April 2021
Estimated completion	15 April 2022
Sites	1 location across Sweden

Drugs / interventions tested

• I-EAET

Conditions studied

• Somatic Symptom Disorder — all drugs for Somatic Symptom Disorder →

Sponsor

Karolinska Institutet

Who can join

18 and older, any sex, with Somatic Symptom Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Internet-based emotional awareness and expression therapy for somatic symptom disorder: A randomized controlled trial.
   Maroti D, Lumley MA, Schubiner H, Lilliengren P, et al · · 2022 · cited 20× · PMID 36327532 · DOI 10.1016/j.jpsychores.2022.111068
2. Psychological therapies delivered remotely for the management of chronic pain (excluding headache) in adults.
   Rosser BA, Fisher E, Janjua S, Eccleston C, et al · · 2023 · cited 13× · PMID 37643992 · DOI 10.1002/14651858.cd013863.pub2
3. Internet-delivered emotional awareness and expression therapy for somatic symptom disorder: one year follow-up.
   Hallberg H, Maroti D, Lumley MA, Johansson R. · · 2024 · cited 2× · PMID 39831062 · DOI 10.3389/fpsyt.2024.1505318
4. Psychometric properties of the emotional processing scale in individuals with psychiatric symptoms and the development of a brief 15-item version.
   Maroti D, Axelsson E, Ljótsson B, Andersson G, et al · · 2022 · cited 1× · PMID 35729355 · DOI 10.1038/s41598-022-14712-x