Trial document




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  DRKS00011001

Trial Description

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Title

Internet-based therapy for bereaved relatives of people who died of cancer

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Trial Acronym

Online grief therapy

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URL of the Trial

https://online-trauertherapie.beranet.info/

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Brief Summary in Lay Language

The loss of a relative due to cancer is a very burdensome experience. Grief is a normal process allowing adjustment to life without the deceased, yet it may be accompanied by feelings of seperation distress, longing for the deceased, or sadness. Most affected people succeed in adapting to their new reality of life. However, some experience intense grief even after months following the loss and suffer from prolonged grief. Psychotherapy can support people in overcoming prolonged grief. Yet, outpatient psychotherapy is often hardly accessible or difficult to incorporate into the everyday life of affected people. Internet-based therapy may be an easily accessible alternative. Previous studies showed a significant decrease of psychological distress after the internet-based therapy in various subgroups of bereaved people. The aim of this study is to evaluate the efficacy of this online therapy tool in the target group of those who lost a significant other to cancer. This study is open to German-speaking adults who lost a significant other to cancer and experience prolonged grief.

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Brief Summary in Scientific Language

The aim of the present study is the evaluation of an internet-based cognitive behavioral therapy program in the group of bereaved who lost a significant other to cancer. Previous studies proved the efficacy of the program in other subgroups of bereaved as well as in the field of psychotraumatology. Furthermore, factors that influence the efficacy of the program are investigated. Aims of the intervention are the reduction of grief intensity and associated psychological symptoms (anxiety, depression, somatization, traumatic experiences), and improvement of quality of life and physical and psychological functioning. The efficacy of the intervention will be examined in a randomized-controlled trial by comparing a waiting control group to an intervention group.

From the start of recruitment 11.01.17 to 25.04.18 the study was limited to relatives of persons who died from haematological cancer. Starting from 26.04.18 the study is open to relatives of persons who died of any cancer.
(Request granted by ethics committee of the medical faculty of the university of Leipzig)

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Organizational Data

  •   DRKS00011001
  •   2016/12/01
  •   [---]*
  •   yes
  •   Approved
  •   450/15-ff, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  •   U1111-1186-6255 
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Health Condition or Problem studied

  •   F43.2 -  Adjustment disorders
  •   Prolonged grief
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Interventions/Observational Groups

  •   Intervention group: The therapy program includes three modules which deal with the domains of self-confrontation, cognitive restructuring and social sharing. The participants receive ten therapeutic writing assignments (45 minutes each), over a span of five weeks. After each assignment patients receive feedback and the next writing instruction.
  •   Control group: this group completes 5 weeks of waiting time before entering the same therapy program.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Prolonged grief measured with the German version of the Inventory of Complicated Grief (ICG-D; Lumbeck, Brandstätter, & Geissner, 2012).
Measured before therapy, immediately after therapy/waiting (after 5 weeks), and 3, 6 and 12 months after therapy.

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Secondary Outcome

Depression (PHQ-9), somatization (PHQ-15), anxiety (GAD-7), posttraumatic distress (IES-R), health related quality of life (SF-12), sleep quality (PSQI), posttraumatic growth (PGI). Measured before therapy, immediately after therapy/waiting (after 5 weeks), and 3, 6 and 12 months after therapy.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2017/01/11
  •   128
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1) 18 years or older
2) loss of a significant other to cancer (11.01.17 to 25.04.18 loss of a significant other to haematological cancer)
3) fluent in German language
4) access to a computer with internet
5) informed consent to participate in the study
6) prolonged grief

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Exclusion Criteria

1) severe depression
2) suicidal ideation
3) psychosis
4) current substance abuse
5) current psychotherpeutic or psychiatric treatment
6) current psychopharmacological treatment if not stable for at least 4 weeks
7) cognitive or physical impairments that would constrain participation in the study
8) tendency to psychological dissociation
9) posttraumatic stress disorder when related to an event other than the loss

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Addresses

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    • Universität Leipzig, Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie
    • Ms.  Prof. Dr. med.  Annette  Kersting 
    • Semmelweisstraße 10
    • 04103  Leipzig
    • Germany
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    • Abteilung für Medizinische Psychologie und Medizinische Soziologie & Sektion Psychosoziale OnkologieDepartment für Psychische GesundheitUniversitätsmedizin Leipzig
    • Ms.  Prof. Dr. phil.  Anja  Mehnert 
    • Philipp-Rosenthal-Straße 55
    • 04103  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig AöRDepartment Innere Medizin, Neurologie und DermatologieAbteilung Hämatologie und Internistische Onkologie
    • Mr.  Prof. Dr. med. Dr. h. c.  Dietger  Niederwieser 
    • Johannisallee 32 A
    • 04103  Leipzig
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Leipzig AöR Department für Psychische Gesundheit Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie
    • Ms.  Prof. Dr. med.  Anette  Kersting 
    • Semmelweisstraße 10
    • 04103  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig AöR Department für Psychische Gesundheit Klinik und Poliklinik für Psychosomatische Medizin und Psychotherapie
    • Ms.  Prof. Dr. med.  Anette  Kersting 
    • Semmelweisstraße 10
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche José Carreras Leukämie-Stiftung e. V. (Förderung der ersten Projektphase vom 01.08.2016 bis 09.03.2018)
    • Elisabethstraße 23
    • 80796  München
    • Germany
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    • Universitätsklinikum Leipzig
    • Liebigstr. 18
    • 04103  Leipzig
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Kurze Vorstellung der Studie in der Zeitschrift FORUM
  •   Hoffmann R, Große J, Nagl M, Niederwieser D, Mehnert A, Kersting A. Internet-based grief therapy for bereaved individuals after loss due to Haematological cancer: Study protocol of a randomized controlled trial. BMC Psychiatry. 2018;18:180. doi:10.1186/s12888-018-1633-y.
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* This entry means the parameter is not applicable or has not been set.