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

Phase 2

Completed

• Conditions: Treatment Satisfaction
• Interventions: Behavioral: self-help program; Behavioral: therapeutic feedback

• Registration Number: NCT02671929
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-01-15
• Study First Submitted QC: 2016-01-29
• Study First Posted: 2016-02-02
• Primary Completion: 2016-05
• Study Completion: 2016-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-27
• Last Update Posted: 2017-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
self-help program	self-help program	Patients in this arm receive access to the internet-based self-help program and don't get any therapeutic feedback
self-help program + feedback	self-help program	Patients in this arm receive access to the internet-based self-help program and get feedback on their progress in the program.
self-help program + feedback	therapeutic feedback	Patients in this arm receive access to the internet-based self-help program and get feedback on their progress in the program.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Utilization of alternative after care measures (psychotherapy and drugs) with a self-devised questionnaire	10 weeks after study inclusion (T1)
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)
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)
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)
Therapeutic alliance measured with the German version of the "WAI-SR" (Working Alliance Inventory - Short Revised)	10 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)
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)
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)
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)

Trial Locations

Locations (1)

University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University; 🇩🇪 Mainz, Rhineland-Palatinate, Germany