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

Treatment Satisfaction Clinical Trial

— KEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02671929
• Other study ID #: RK-91809
• Status: Completed
• Phase: Phase 2
• First received: January 15, 2016
• Last updated: October 27, 2017
• Start date: September 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2017
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Treatment Satisfaction

Intervention

Behavioral:
• self-help program
Access to the internet-based self-help program
• therapeutic feedback
Therapeutic feedback on the written information sent to the online therapist

Locations

Country	Name	City	State
Germany	University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University	Mainz	Rhineland-Palatinate

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Zwerenz R, Becker J, Johansson R, Frederick RJ, Andersson G, Beutel ME. Transdiagnostic, Psychodynamic Web-Based Self-Help Intervention Following Inpatient Psychotherapy: Results of a Feasibility Study and Randomized Controlled Trial. JMIR Ment Health. 2017 Oct 16;4(4):e41. doi: 10.2196/mental.7889. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Therapeutic alliance measured with the German version of the "WAI-SR" (Working Alliance Inventory - Short Revised)		10 weeks after study inclusion (T1)
Secondary	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)
Secondary	Acceptance of the internet-based self-help program measured with an especially for the self-help program devised questionnaire		End of every unit (weekly) and 10 weeks after study inclusion (T1)
Secondary	Usage of the internet-based self-help program measured with an especially for the self-help program devised questionnaire		10 weeks after study inclusion (T1)
Secondary	Utilization of alternative after care measures (psychotherapy and drugs) with a self-devised questionnaire		10 weeks after study inclusion (T1)