Clinical trial NCT02671929: Translation and Development of an Online Self-help Intervention With Subsequent Feasibility Study
Official title: Translation and Development of an Online Self-help Intervention With Subsequent Feasibility Study as an After Care After Inpatient Psychosomatic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Treatment Satisfaction
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Satisfaction of the intervention group with the internet-based self-help program measured with an reworded version of the "patient satisfaction questionnaire" (ZUF-8)
timeFrame: 10 weeks after study inclusion (T1)
Secondary outcomes:
measure: Emotional competence measured with the "SEK-27" (questionnaire for self-assessment of emotional competence)
timeFrame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
measure: Depression measured with the German version of the "PHQ-9" (Patient Health Questionnaire)
timeFrame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
measure: Quality of life measured with the German version of the "EUROHIS-QOL 8" (European Health Interview Survey Quality of Life 8)
timeFrame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
measure: Anxiety measured with the German version of the "GAD-7" (General Anxiety Disorder Screener)
timeFrame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
measure: Self-esteem measured with the German version of the "RSE" (Rosenberg Self-Esteem Scale)
timeFrame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
measure: Somatoform afflictions measured with the German version of the "SSS-8" (Somatic Symptom Scale)
timeFrame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
measure: Subjective prognosis of work ability measured with the "SPE" (Subjective Prognosis of Work Ability)
timeFrame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
measure: Therapeutic alliance measured with the German version of the "WAI-SR" (Working Alliance Inventory - Short Revised)
timeFrame: 10 weeks after study inclusion (T1)
measure: Depersonalisation measured with the German short version of the "CDS-2" (Cambridge Depersonalisation Scale)
timeFrame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2)
measure: Acceptance of the internet-based self-help program measured with an especially for the self-help program devised questionnaire
timeFrame: End of every unit (weekly) and 10 weeks after study inclusion (T1)
measure: Usage of the internet-based self-help program measured with an especially for the self-help program devised questionnaire
timeFrame: 10 weeks after study inclusion (T1)
measure: Utilization of alternative after care measures (psychotherapy and drugs) with a self-devised questionnaire
timeFrame: 10 weeks after study inclusion (T1)
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University
state: Rhineland-Palatinate
Study officials:
affiliation: Department for Psychosomatic Medicine and Psychotherapy at the University Medical Center of the Johannes Gutenberg-University Mainz
name: Manfred E Beutel, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: 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.