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NCT Number: NCT02196896

Enhancing Inpatient Psychotherapeutic Treatment With Online Self-help : Acceptance and Efficacy

The purpose of this study is to determine the acceptance and efficacy of the online self-help program deprexis® for depressed patients in reducing the clinical symptoms of their depression. The patients of the experimental group use deprexis® for 90 days, the patients of the placebo group receive weekly online information about depression for 90 days as well. Both groups receive their treatment in addition to their regular inpatient psychosomatic treatment and as an aftercare intervention.The investigators hypothesize that the online self-help group achieves a greater reduction of depression compared to the control group.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychosomatic Clinic Bad Neustadt, Bad Neustadt an der Saale, Bavaria, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Inpatient treatment
  • Private internet access
  • Informed consent
  • Age between 18 and 65 years
  • Knowledge of the German language
  • Score in the BDI-II > 13 and clinical diagnosis of a depression (ICD-10: F32.x, F33.x, F34.1, F43.2) verified by the inpatient therapist

Exclusion criteria

  • Psychosis
  • Current alcohol or drug dependency
  • Borderline, antisocial, schizoid or schizotypal personality disorder
  • Anorexia nervosa
  • Life time diagnosis of a schizophrenia, schizoaffective , bipolar oder organic psychic disorder

Treatment and study plan

deprexis®

Other

Online self-help program in addition to inpatient psychosomatic treatment for 90 days.

Information

Other

The patients receive online information about depression once a week for 90 days.

Primary outcomes

  1. Reduction of depression measured with the "Beck's Depression Inventory" (BDI-II)

    Time frame: Three months after randomization

Secondary outcomes

  1. Reduction of depression measured with the depression scale of the "Patient Health Questionnaire" (PHQ-9)

    Time frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization

  2. Reduction of depression measured with the "Beck's Depression Inventory" (BDI-II)

    Time frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization

  3. Reduction of anxiety measured with the "Generalized Anxiety Disorder Scale" (GAD-7)

    Time frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization

  4. Reduction of dysfunctional depression related cognitions measured with the "Dysfunctional Attitude Scale" (DAS)

    Time frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization

  5. Improved self-esteem measured with the "Rosenberg Self-Esteem Scale" (RSE)

    Time frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization

  6. Improved quality of life measured with the "European Health Interview Survey Quality of Life-8" (EUROHIS-QOL 8)

    Time frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization

  7. Improved working ability measured with the short form of the "Work Ability Index" (WAI)

    Time frame: Randomization, end of inpatient treatment (average 6 weeks), six months after randomization

  8. Acceptance and utilization of deprexis® measured with a self devised questionnaire

    Time frame: End of inpatient treatment (average 6 weeks), three months after randomization

  9. Acceptance and utilization of the information used in the placebo condition measured with a self devised questionnaire

    Time frame: End of inpatient treatment (average 6 weeks), three months after randomization

  10. Degree of childhood traumas measured with the "Childhood Trauma Questionnaire" (CTQ)

    Time frame: Randomization

    Assumption that childhood traumas, assessed at the beginning of treatment, have a moderating effect on the reduction in the primary outcome measure.

  11. Degree of structural deficits measured with the short form of the OPD-Structure Questionnaire (OPD-SFK)

    Time frame: Randomization

    Assumption that structural deficits, as assessed with the OPD-SFK questionnaire at the beginning of treatment have a moderating effect on the reduction in the primary outcome measure.

  12. Therapeutic alliance between participant and inpatient psychotherapist measured with the "Helping Alliance Questionnaire" (HAQ).

    Time frame: Randomization, end of inpatient treatment (average 6 weeks)

  13. Course of mood, depressiveness and utilization of units

    Time frame: During inpatient treatment (average 6 weeks)

  14. Utilization of other treatments after the end of inpatient treatment

    Time frame: Six months after randomization

  15. Satisfaction with inpatient treatment

    Time frame: End of inpatient treatment (average 6 weeks)

  16. Willingness to pay

    Time frame: Three months after randomization

  17. Remission from depression

    Time frame: End of inpatient treatment (average 6 weeks), three months after randomization, six months after randomization

    BDI score below the cutoff of 13 and a reliable change regarding Reliable Change Index (RCI)

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Collaborators

  • Rhön-Klinikum AG

Registry information

Official study title

Enhancing Inpatient Psychotherapeutic Treatment With Online Self Help in a Randomised Controlled Trial: Acceptance and Efficacy

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2014
Registry last updated
Mar 17, 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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