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

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

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.

Study Overview

• Status: Completed
• Conditions: Treatment Satisfaction
• Intervention / Treatment: Behavioral: self-help program; Behavioral: therapeutic feedback

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.	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	Behavioral: self-help program; Access to the internet-based self-help program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 Outcome Measures

Outcome Measure	Time Frame
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)
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)
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)
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)
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)
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)
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 questionnaire	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	10 weeks after study inclusion (T1)
Utilization of alternative after care measures (psychotherapy and drugs) with a self-devised questionnaire	10 weeks after study inclusion (T1)

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Investigators: Study Director: Manfred E Beutel, Prof. Dr., Department for Psychosomatic Medicine and Psychotherapy at the University Medical Center of the Johannes Gutenberg-University Mainz

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: January 15, 2016
• First Submitted That Met QC Criteria: January 29, 2016
• First Posted (Estimate): February 2, 2016

Study Record Updates

• Last Update Posted (Actual): October 30, 2017
• Last Update Submitted That Met QC Criteria: October 27, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: RK-91809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO