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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00014375
Date of registration:	20/06/2018
Prospective Registration:	Yes
Primary sponsor:	Johannes Gutenberg-Universität Mainz; Psychologisches Institut; Abteilung für Klinische Psychologie, Psychotherapie und Experimentelle Psychopathologie
Public title:	Efficacy of an Internet-based intervention for somatic symptoms in university students (iSOMA): a randomized controlled trial
Scientific title:	Efficacy of an Internet-based intervention for somatic symptoms in university students (iSOMA): a randomized controlled trial - iSOMA - online training
Date of first enrolment:	29/08/2018
Target sample size:	154
Recruitment status:	Complete
URL:	http://drks.de/search/en/trial/DRKS00014375
Study type:	interventional
Study design:	Allocation: Randomized controlled study; Masking: Open (masking not used); Control: No treatment / Standard of care; Assignment: parallel; Study design purpose: prevention
Phase:	N/A

Countries of recruitment
Austria	Germany	Switzerland

Contacts

Name:	Severin Hennemann
Address:	Wallstraße 3 55122 Mainz Germany
Telephone:	061313939215
Email:	s.hennemann@uni-mainz.de
Affiliation:	Johannes Gutenberg-Universität Mainz; Psychologisches Institut; Abteilung für Klinische Psychologie, Psychotherapie und experimentelle Psychopathologie

Name:	Severin Hennemann
Address:	Wallstraße 3 55122 Mainz Germany
Telephone:	06131 39 39 215
Email:	s.hennemann@uni-mainz.de
Affiliation:	Johannes Gutenberg-Universität Mainz; Psychologisches Institut; Abteilung für Klinische Psychologie, Psychotherapie und experimentelle Psychopathologie

Key inclusion & exclusion 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: /

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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, attention shift); 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.

Primary Outcome(s)

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(s)

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).

Secondary ID(s)

Source(s) of Monetary Support

Studicare: Barmer GEK

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

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 08/01/2018
Contact:

ethikkommission-psychologie@uni-mainz.de

Ethikkommission des Psychologischen Instituts; Universität Mainz

ethikkommission-psychologie@uni-mainz.de

Results

Results available:
Date Posted:
Date Completed:	14/08/2020
URL:	http://drks.de/search/en/trial/DRKS00014375#studyResults

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