Internet-based Emotional Awareness and Expression Therapy for Somatic Symptom Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- PHQ-15
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Treatment (Emotional Awareness and Expression Therapy)
Internet-based Emotional Awareness and Expression Therapy
Intervention: Emotional Awareness and Expression Therapy (Behavioral)
Outcomes
Primary Outcomes
PHQ-15
Time Frame: At study completion, after 4 months
Patient Health Questionnaire Physical Symptoms
PHQ-15
Time Frame: Baseline
Patient Health Questionnaire Physical Symptoms
PHQ-15
Time Frame: Weekly during treatment, for 9 weeks
Change in physical symptoms (as measured by the PHQ-15)
PHQ-15
Time Frame: At study completion, after 9 weeks
Patient Health Questionnaire Physical Symptoms
Secondary Outcomes
- PHQ-9(At study completion, after 4 months)
- GAD-7(At study completion, after 4 months)
- SDS(At study completion, after 4 months)
- PHQ-9(Baseline)
- PHQ-9(At study completion, after 9 weeks)
- GAD-7(Baseline)
- GAD-7(At study completion, after 9 weeks)
- SDS(Baseline)
- SDS(At study completion, after 9 weeks)
Investigators
Robert Johansson
Associate professor
Karolinska Institutet