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Completed

NCT Number: NCT04122846

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

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.

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Key information

Conditions

Somatic Symptom Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emotional Awareness and Expression Therapy

Behavioral

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

Primary outcomes

  1. PHQ-15

    Time frame: Baseline

    Patient Health Questionnaire Physical Symptoms

  2. PHQ-15

    Time frame: Weekly during treatment, for 9 weeks

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

  3. PHQ-15

    Time frame: At study completion, after 9 weeks

    Patient Health Questionnaire Physical Symptoms

  4. PHQ-15

    Time frame: At study completion, after 4 months

    Patient Health Questionnaire Physical Symptoms

Secondary outcomes

  1. PHQ-9

    Time frame: Baseline

    Patient Health Questionnaire Depression

  2. PHQ-9

    Time frame: At study completion, after 9 weeks

    Patient Health Questionnaire Depression

  3. PHQ-9

    Time frame: At study completion, after 4 months

    Patient Health Questionnaire Depression

  4. GAD-7

    Time frame: Baseline

    Patient Health Questionnaire Anxiety

  5. GAD-7

    Time frame: At study completion, after 9 weeks

    Patient Health Questionnaire Anxiety

  6. GAD-7

    Time frame: At study completion, after 4 months

    Patient Health Questionnaire Anxiety

  7. SDS

    Time frame: Baseline

    Sheehan Disability Scale

  8. SDS

    Time frame: At study completion, after 9 weeks

    Sheehan Disability Scale

  9. SDS

    Time frame: At study completion, after 4 months

    Sheehan Disability Scale

Other outcomes

  1. EPS-25

    Time frame: Baseline

    Emotional Processing Scale (Measure of treatment process)

  2. EPS-25

    Time frame: Weekly during treatment, for 9 weeks

    Emotional Processing Scale (Measure of treatment process)

  3. EPS-25

    Time frame: At study completion, after 9 weeks

    Emotional Processing Scale (Measure of treatment process)

  4. EPS-25

    Time frame: At study completion, after 4 months

    Emotional Processing Scale (Measure of treatment process)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Stockholm University

Registry information

Acronym: MBS1

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 10, 2019
Registry last updated
Apr 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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