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

Study Overview
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Brief Summary
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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.

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

Conditions
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Treatment Satisfaction

Intervention / Treatment
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* Behavioral: self-help program
* Behavioral: therapeutic feedback


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: self-help program + feedback<br>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<br>* Access to the internet-based self-help program<br>Behavioral: therapeutic feedback<br>* Therapeutic feedback on the written information sent to the online therapist<br>|
| Active Comparator: self-help program<br>Patients in this arm receive access to the internet-based self-help program and don't get any therapeutic feedback | Behavioral: self-help program<br>* Access to the internet-based self-help program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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) |