Efficacy of an Internet-based intervention for somatic symptoms in university students (iSOMA): a randomized controlled trial

Efficacy of an Internet-based intervention for somatic symptoms in university students (iSOMA): a randomized controlled trial - iSOMA - online training

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00014375

Enrollment

154

Registered

2018-06-20

Start date

2018-08-29

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

somatic symptoms and related distress (measured dimensionally with self-report)

Interventions

Group 1: Intervention group with immediate access after randomization to an e-coach guided internet-based intervention based on principles of Cognitive Behavioral therapy (e. g. coping with stress, at

consisting of seven weekly modules. Group 2: Waitlist control group

access to same internet-based training as intervention group (guidance on demand) after waiting period of 8 weeks post-randomization.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: /

Design outcomes

Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Primary

Measure	Time frame
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.	—

Countries

Austria, Germany, Switzerland

Contacts

Public ContactSeverin Hennemann

Johannes Gutenberg-Universität Mainz; Psychologisches Institut; Abteilung für Klinische Psychologie, Psychotherapie und experimentelle Psychopathologie

s.hennemann@uni-mainz.de061313939215

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 22, 2026