Efficacy of an Internet-based intervention for somatic symptoms in university students (iSOMA): a randomized controlled trial
Not Applicable
- Conditions
- somatic symptoms and related distress (measured dimensionally with self-report)
- Registration Number
- DRKS00014375
- Lead Sponsor
- Johannes Gutenberg-Universität Mainz; Psychologisches Institut; Abteilung für Klinische Psychologie, Psychotherapie und Experimentelle Psychopathologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 156
Inclusion Criteria
At least moderate somatic symtpoms (PHQ-15 = 4); minimum age 18 years; enrolled as a university student; sufficient knowledge of the German language; Internet access; informed consent
Exclusion Criteria
/
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Somatic symptom and associated distress measured with the Patient Health Questionnaire (PHQ-15) and the Somatic Symptom Disorder - B Criteria Scale (SSD-12). Measurement before and 8/16 weeks afer randomization.
- Secondary Outcome Measures
Name Time Method Depression (PHQ-9); anxiety (GAD-7); health anxiety (mSHAI); level of functioning (PDI); attitudes towards (face-to-face) psychotherapy (ATSPPH); intervention satisfaction (CSQ-I); adherence (number of completed modules). Measurement before randomisation and 8/16 weeks thereafter. Covariates: demographics; medical variables; somatosensory amplification (SSAS); expectancy (CEQ); emotional reactivity (ERS); therapeutic alliance (WAI-SR); subjective side effects (INEP).