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NCT Number: NCT02671929

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

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.

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Key information

Conditions

Treatment Satisfaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Medical Center, Department of Psychosomatic Medicine and Psychotherapy, Johannes Gutenberg University

Mainz, Rhineland-Palatinate, 55131, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

self-help program

Behavioral

Access to the internet-based self-help program

therapeutic feedback

Behavioral

Therapeutic feedback on the written information sent to the online therapist

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

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

Acronym: KEN

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 2, 2016
Registry last updated
Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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