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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00025555
Enrollment
50
Registered
2021-06-14
Start date
2022-08-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bodily distress (somatoform syndrome)

Interventions

Group 1: The intervention group receives the browser-based modular internet intervention (iSOMA). iSOMA consists of seven consecutive lectures based on a cognitive-behavioral therapy treatment manual

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: Acute suicidality or psychotic states; Severe depressive disorder; Substance dependence

Design outcomes

Secondary

MeasureTime frame
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). In addition, the following outcome measures will only be collected at specific time points: T1: Adherence (number of complete iSOMA lectures), intervention satisfaction (CSQ-I), adverse effects (NEQ). T2: adverse effects (NEQ).

Primary

MeasureTime frame
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).

Countries

Germany

Contacts

Public ContactSeverin Hennemann

Psychologisches Institut der Universität Mainz (Abt. Klinische Psychologie, Psychotherapie und Experimentelle Psychopathologie)

s.hennemann@uni-mainz.de061313939215

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026