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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671929
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Rüdiger Zwerenz, 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.

Condition or disease Intervention/treatment Phase
Treatment Satisfaction Behavioral: self-help program Behavioral: therapeutic feedback Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Translation and Development of an Online Self-help Intervention With Subsequent Feasibility Study as an After Care After Inpatient Psychosomatic Treatment
Study Start Date : September 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : July 2016

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




Primary Outcome Measures :
  1. Satisfaction of the intervention group with the internet-based self-help program measured with an reworded version of the "patient satisfaction questionnaire" (ZUF-8) [ Time Frame: 10 weeks after study inclusion (T1) ]

Secondary Outcome Measures :
  1. Emotional competence measured with the "SEK-27" (questionnaire for self-assessment of emotional competence) [ Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2) ]
  2. Depression measured with the German version of the "PHQ-9" (Patient Health Questionnaire) [ Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2) ]
  3. Quality of life measured with the German version of the "EUROHIS-QOL 8" (European Health Interview Survey Quality of Life 8) [ Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2) ]
  4. Anxiety measured with the German version of the "GAD-7" (General Anxiety Disorder Screener) [ Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2) ]
  5. Self-esteem measured with the German version of the "RSE" (Rosenberg Self-Esteem Scale) [ Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2) ]
  6. Somatoform afflictions measured with the German version of the "SSS-8" (Somatic Symptom Scale) [ Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2) ]
  7. Subjective prognosis of work ability measured with the "SPE" (Subjective Prognosis of Work Ability) [ Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2) ]
  8. Therapeutic alliance measured with the German version of the "WAI-SR" (Working Alliance Inventory - Short Revised) [ Time Frame: 10 weeks after study inclusion (T1) ]
  9. Depersonalisation measured with the German short version of the "CDS-2" (Cambridge Depersonalisation Scale) [ Time Frame: 10 weeks after study inclusion (T1) and 19 weeks after study inclusion (T2) ]
  10. Acceptance of the internet-based self-help program measured with an especially for the self-help program devised questionnaire [ Time Frame: End of every unit (weekly) and 10 weeks after study inclusion (T1) ]
  11. Usage of the internet-based self-help program measured with an especially for the self-help program devised questionnaire [ Time Frame: 10 weeks after study inclusion (T1) ]
  12. Utilization of alternative after care measures (psychotherapy and drugs) with a self-devised questionnaire [ Time Frame: 10 weeks after study inclusion (T1) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671929


Locations
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Germany
University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University
Mainz, Rhineland-Palatinate, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
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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:
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Responsible Party: Dr. Rüdiger Zwerenz, Principle Investigator, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT02671929    
Other Study ID Numbers: RK-91809
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No