Effectiveness of a cognitive-behavioral Internet intervention for bodily distress (iSOMA) in university students

Phase 4

Recruiting

Conditions: Bodily distress (somatoform syndrome)

Registration Number: DRKS00025555

Lead Sponsor: Johannes Gutenberg-Universität MainzPsychologisches Institut Abteilung für Klinische Psychologie, Psychotherapie und Experimentelle Psychopathologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Minimum age 18 years; Presence of a somatic syndrome as defined by a sum score = 6 on the PHQ-15; Student status at the University of Mainz;
Sufficient knowledge of German; Full informed consent.

Exclusion Criteria

Acute suicidality or psychotic states; Severe depressive disorder; Substance dependence

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in somatic symptom severity as measured by the Patient Health Questionnaire (PHQ-15) from baseline (T0) to post-treatment (T1) and 6 months follow-up (T2).

Secondary Outcome Measures

Name	Time	Method
The following secondary outcome measures will be assessed at all 3 time points (baseline (T0), post-intervention (T1), 6-month follow-up (T2)) using self-reports via online questionnaires: psychobehavioral features of somatic symptom distress (SSD-12); depression (ADS); anxiety (BSCL), functioning (PDI), pain coping (FESV), health care utilization (self-constructed). <br>In addition, the following outcome measures will only be collected at specific time points: <br>T1: Adherence (number of complete iSOMA lectures), intervention satisfaction (CSQ-I), adverse effects (NEQ).<br>T2: adverse effects (NEQ).