Translation and Development of an Online Self-help Intervention With Subsequent Feasibility Study (KEN)
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ClinicalTrials.gov Identifier: NCT02671929 |
Recruitment Status :
Completed
First Posted : February 2, 2016
Last Update Posted : October 30, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Treatment Satisfaction | Behavioral: self-help program Behavioral: therapeutic feedback | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 83 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Translation and Development of an Online Self-help Intervention With Subsequent Feasibility Study as an After Care After Inpatient Psychosomatic Treatment |
Study Start Date : | September 2015 |
Actual Primary Completion Date : | May 2016 |
Actual Study Completion Date : | July 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: self-help program + feedback
Patients in this arm receive access to the internet-based self-help program and get feedback on their progress in the program.
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Behavioral: self-help program
Access to the internet-based self-help program Behavioral: therapeutic feedback Therapeutic feedback on the written information sent to the online therapist |
Active Comparator: self-help program
Patients in this arm receive access to the internet-based self-help program and don't get any therapeutic feedback
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Behavioral: self-help program
Access to the internet-based self-help program |
- Satisfaction of the intervention group with the internet-based self-help program measured with an reworded version of the "patient satisfaction questionnaire" (ZUF-8) [ Time Frame: 10 weeks after study inclusion (T1) ]
- Emotional competence measured with the "SEK-27" (questionnaire for self-assessment of emotional competence) [ Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2) ]
- Depression measured with the German version of the "PHQ-9" (Patient Health Questionnaire) [ Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2) ]
- Quality of life measured with the German version of the "EUROHIS-QOL 8" (European Health Interview Survey Quality of Life 8) [ Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2) ]
- Anxiety measured with the German version of the "GAD-7" (General Anxiety Disorder Screener) [ Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2) ]
- Self-esteem measured with the German version of the "RSE" (Rosenberg Self-Esteem Scale) [ Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2) ]
- Somatoform afflictions measured with the German version of the "SSS-8" (Somatic Symptom Scale) [ Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2) ]
- Subjective prognosis of work ability measured with the "SPE" (Subjective Prognosis of Work Ability) [ Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2) ]
- Therapeutic alliance measured with the German version of the "WAI-SR" (Working Alliance Inventory - Short Revised) [ Time Frame: 10 weeks after study inclusion (T1) ]
- Depersonalisation measured with the German short version of the "CDS-2" (Cambridge Depersonalisation Scale) [ Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2) ]
- Acceptance of the internet-based self-help program measured with an especially for the self-help program devised questionnaire [ Time Frame: End of every unit (weekly) and 10 weeks after study inclusion (T1) ]
- Usage of the internet-based self-help program measured with an especially for the self-help program devised questionnaire [ Time Frame: 10 weeks after study inclusion (T1) ]
- Utilization of alternative after care measures (psychotherapy and drugs) with a self-devised questionnaire [ Time Frame: 10 weeks after study inclusion (T1) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- day care/ inpatient treatment in the Department of Psychosomatic Medicine and Psychotherapy at the University Medical Center of the Johannes Gutenberg-University Mainz
- minimum age of 18 years
- private internet access
- e-mail address
Exclusion Criteria:
- acute suicidality
- psychosis
- current alcohol or drug addiction
- life time diagnosis of a schizophrenic, schizoaffective, bipolar or organic psychic disorder

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671929
Germany | |
University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University | |
Mainz, Rhineland-Palatinate, Germany, 55131 |
Study Director: | Manfred E Beutel, Prof. Dr. | Department for Psychosomatic Medicine and Psychotherapy at the University Medical Center of the Johannes Gutenberg-University Mainz |
Responsible Party: | Dr. Rüdiger Zwerenz, Principle Investigator, Johannes Gutenberg University Mainz |
ClinicalTrials.gov Identifier: | NCT02671929 |
Other Study ID Numbers: |
RK-91809 |
First Posted: | February 2, 2016 Key Record Dates |
Last Update Posted: | October 30, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |