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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

Tracking Information
First Submitted Date  ICMJE January 15, 2016
First Posted Date  ICMJE February 2, 2016
Last Update Posted Date October 30, 2017
Study Start Date  ICMJE September 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • Therapeutic alliance measured with the German version of the "WAI-SR" (Working Alliance Inventory - Short Revised) [ Time Frame: 10 weeks after study inclusion (T1) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • Utilization of alternative after care measures (psychotherapy and drugs) with a self-devised questionnaire [ Time Frame: 10 weeks after study inclusion (T1) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Translation and Development of an Online Self-help Intervention With Subsequent Feasibility Study
Official Title  ICMJE Translation and Development of an Online Self-help Intervention With Subsequent Feasibility Study as an After Care After Inpatient Psychosomatic 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Treatment Satisfaction
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: self-help program
    • Behavioral: therapeutic feedback
  • 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
    Intervention: Behavioral: self-help program
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2016)
83
Original Estimated Enrollment  ICMJE
 (submitted: January 29, 2016)
60
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02671929
Other Study ID Numbers  ICMJE RK-91809
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Rüdiger Zwerenz, Johannes Gutenberg University Mainz
Study Sponsor  ICMJE Johannes Gutenberg University Mainz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Manfred E Beutel, Prof. Dr. Department for Psychosomatic Medicine and Psychotherapy at the University Medical Center of the Johannes Gutenberg-University Mainz
PRS Account Johannes Gutenberg University Mainz
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP