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

NCT ID: NCT04122846

Last Updated: 2020-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2020-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Somatic Symptom Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Emotional Awareness and Expression Therapy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (Emotional Awareness and Expression Therapy)

Internet-based Emotional Awareness and Expression Therapy

Group Type EXPERIMENTAL

Emotional Awareness and Expression Therapy

Intervention Type BEHAVIORAL

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

Interventions

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Emotional Awareness and Expression Therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stockholm University

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Robert Johansson

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Johansson, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institutet

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 33679478 (View on PubMed)

Other Identifiers

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KIMBS1

Identifier Type: -

Identifier Source: org_study_id

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