Somatic Symptom Disorder (DSM-5)
Conditions
Interventions
Group 1: Blended Care, consisting of individual psychotherapy (20 sessions) + online intervention (7 modules), approx. 6 months treatment duration)
Group 2: Standard treatment, consisting of individua
Sponsors
Johannes Gutenberg-Universität Mainz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Main diagnosis of Somatic Symptom Disorder according to DSM-5 via DIPS 2) Sufficient level of symptom severity in the Patient Health Questionnaire, somatic symptom version (PHQ-15 = 5) 3) Disability in an adapted version of the Pain Disability Inventory (PDI = 4) 4) Private internet-access and an internet-capable device 5) Signed "informed consent"
Exclusion criteria
Exclusion criteria: 1) Any acute, severe, or unstable physical condition (e.g., organic brain disorders, severe cognitive deficits) that does not allow for safe participa-tion based on the patient's self-reports, existing medical documentation (including consultation report) 2) Insufficient German reading and/or language skills 3) Substance use disorders 4) Acute psychotic state 5) Acute suicidality 6) Parallel psychological treatment 7) Parallel participation in another intervention study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Somatic symptom severity, assessed via SOMS-7R intensity index, from baseline to post-assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurement points: Baseline, therapy session 1, 5, 10, and 15, Post (end of treatment), Follow-Up (6 months after end of treatment) The following constructs will be assessed in patients using these questionnaires at the specified time points: - Somatic symptom severity, SOMS-7R: Baseline, Sessions 1, 5, 10, 15, Post, Follow-Up. - Self-efficacy, FESS: Baseline, Sessions 1, 5, 10, 15, Post, Follow-Up. - Disability, PDI (modified version): Baseline, Sessions 1, 5, 10, 15, Post, Follow-Up. - Psychological and behavioral aspects of somatic symptom disorder, SSD-12: Baseline, Post, Follow-Up. - Depression, PHQ-9: Baseline, Post, Follow-Up. - Symptom coping, FESV – subscales cognitive and behavioral coping: Baseline, Post, Follow-Up. - Generalized anxiety, GAD-7: Baseline, Post, Follow-Up. - Illness worries, (WI): Baseline, Post, Follow-Up. - Quality of life, WHOQOL-BREF: Baseline, Post, Follow-Up. - Experience in personal social systems, EXIS.pers: Baseline, Post, Follow-Up. - Main diagnosis of Somatic Symptom Disorder, DIPS: Baseline, Post, Follow-Up. Covariates/Moderators/Mediators: - Traumatic experiences, CTS: Baseline. - Treatment agency, TAI – subscale therapeutic-processing: Sessions 1, 5, 10, 15, Post. - Therapeutic alliance, WAI-SR: Session 1, 5, 10, 15. - Previous treatment experiences, treatment expectations & treatment effects, GEEE: Baseline, Session 1, 5, 10, 15, Post, Follow-up. - Warmth & Competence, W&C: Sessions 1, 5, 10, 15. - Health care utilization, HCU-Q: Baseline, Post, Follow-Up. - General treatment satisfaction, ZUF-8: Post. - Demographic and clinical information: Baseline. - Diagnoses of mental disorders/comorbidities, Mini-DIPS: Baseline. - In both study arms, adherence and intervention usage will be continuously assessed throughout the treatment. Safety: - Negative treatment effects, NEQ: Post. - (serious) adverse events, self-developed checklist; to be completed by therapists: Session 1, 5, 10, 15, Post, Fo | — |
Countries
Germany
Contacts
Public ContactSeverin Hennemann
Johannes Gutenberg-Universität Mainz
Outcome results
None listed