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Translation and Development of an Online Self-help Intervention With Subsequent Feasibility Study

Translation and Development of an Online Self-help Intervention With Subsequent Feasibility Study as an After Care After Inpatient Psychosomatic Treatment

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02671929
Acronym
KEN
Enrollment
83
Registered
2016-02-02
Start date
2015-09-30
Completion date
2016-07-31
Last updated
2017-10-30

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

Conditions

Treatment Satisfaction

Brief summary

The purpose of this study is to determine the feasibility and effectiveness of an internet-based self help program concerning satisfaction with the treatment and their life, depression and anxiety. Both study groups get access to the internet-based self-help program. The intervention group receives additional feedback to their progress in the program from an online therapist. The investigators hypothesize that (1) at least 75% of the patients in the intervention group are satisfied or very satisfied with the self-help program, (2) 50% of the patients in the intervention group work with all eight units and (3) patients of the intervention group have a higher emotional competence than the patients of the control group at the end of the self-help program.

Interventions

Access to the internet-based self-help program

BEHAVIORALtherapeutic feedback

Therapeutic feedback on the written information sent to the online therapist

Sponsors

Johannes Gutenberg University Mainz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Satisfaction of the intervention group with the internet-based self-help program measured with an reworded version of the patient satisfaction questionnaire (ZUF-8)10 weeks after study inclusion (T1)

Secondary

MeasureTime frame
Subjective prognosis of work ability measured with the SPE (Subjective Prognosis of Work Ability)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)10 weeks after study inclusion (T1)
Anxiety measured with the German version of the GAD-7 (General Anxiety Disorder Screener)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)10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
Emotional competence measured with the SEK-27 (questionnaire for self-assessment of emotional competence)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)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)10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
Depersonalisation measured with the German short version of the CDS-2 (Cambridge Depersonalisation Scale)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 questionnaireEnd 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 questionnaire10 weeks after study inclusion (T1)
Utilization of alternative after care measures (psychotherapy and drugs) with a self-devised questionnaire10 weeks after study inclusion (T1)
Depression measured with the German version of the PHQ-9 (Patient Health Questionnaire)10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026