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

NCT04122846 | Completed DMC

• 1 other identifier: KIMBS1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Somatic Symptom Disorder

Outcome Measures

Primary Outcomes (4)

• PHQ-15

  Patient Health Questionnaire Physical Symptoms

  Baseline

• PHQ-15

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

  Weekly during treatment, for 9 weeks

• PHQ-15

  Patient Health Questionnaire Physical Symptoms

  At study completion, after 9 weeks

• PHQ-15

  Patient Health Questionnaire Physical Symptoms

  At study completion, after 4 months

Secondary Outcomes (9)

• PHQ-9

  Baseline

• PHQ-9

  At study completion, after 9 weeks

• PHQ-9

  At study completion, after 4 months

• GAD-7

  Baseline

• GAD-7

  At study completion, after 9 weeks

Other Outcomes (4)

• EPS-25

  Baseline

• EPS-25

  Weekly during treatment, for 9 weeks

• EPS-25

  At study completion, after 9 weeks

Study Arms (1)

Treatment (Emotional Awareness and Expression Therapy)

EXPERIMENTAL

Internet-based Emotional Awareness and Expression Therapy

Behavioral: Emotional Awareness and Expression Therapy

Interventions

Emotional Awareness and Expression Therapy BEHAVIORAL

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

Treatment (Emotional Awareness and Expression Therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Stockholm University: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (1)

• 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.

  PMID: 33679478 DERIVED

Study Officials

• Robert Johansson, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Emotional Awareness and Expression Therapy

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 10, 2019
• Study Start: September 30, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)