Trial document




drksid header

  DRKS00012317

Trial Description

start of 1:1-Block title

Title

Treating Prolonged Grief Disorder with Prolonged Grief-Specific Cognitive Behavioral Therapy: A Multicenter Parallel Group Randomized Controlled Trial

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

PROGRID

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.trauer-therapie.de

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Even though grief is experienced on a very individual level, reactions to loss are mostly similar in people with the same cultural background, for example regarding course and length. After a certain amount of time, getting back to everyday life becomes less difficult.
When grief persists longer and is more intense than in most other people, clinicians refer to it as “prolonged grief disorder” (PGD). Even months after the loss there is no noticeable improvement and managing everyday life remains hard.
There are various approaches for the treatment of PGD. The overall aim of the PROGRID study is to compare the effectiveness of two different therapy protocols: One focusses more on grief itself, the other focusses more on problems in day-to-day life. Both approaches have already been proven to be effective for other mental health problems – new is the adaption for grieving patients.
The study takes place at four different sites: Frankfurt, Ingolstadt, Leipzig and Marburg. Participation is possible for people aged 18 to 75 years, who lost a significant other more than six months ago.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Prolonged grief disorder (PGD) has emerged as a well-defined mental disorder, distinguishable from major depression and posttraumatic stress disorder or other stress-related disorders (Jordan & Litz, 2014). However, there are still not enough interventional studies and some of the already published trials have small sample sizes or did not require PGD diagnosis as inclusion criterion but included subthreshold cases as well.
The overall aim of PROGRID is to compare the effectiveness of an integrative cognitive behavioral therapy for prolonged grief (PG-CBT; Pfoh, Kotoucová & Rosner, 2015) and a grief-adapted present-centered therapy (PCT; Schnurr, Friedman, Foy et al., 2003; Shea, Bernardy, Howard, Key, & Lambert, 2003) in a randomized controlled trial. Altogether 204 patients with a primary diagnoses of PGD will be included, recruited at four study sites.
Primary endpoint is grief symptom severity assessed in interview by trained raters blinded to treatment condition 12 months after randomization. Secondary outcomes are PGD grief symptom severity at post-treatment, in addition to self-reported overall mental health symptoms, depressive and somatoform symptoms, at post-treatment and 12 months post-randomization.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00012317
  •   2017/09/06
  •   [---]*
  •   yes
  •   Approved
  •   2016/21, Ethikkommission der Philosophisch-Pädagogischen Fakultät der Katholischen Universität Eichstätt-Ingolstadt
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Prolonged grief disorder (PGD) – expected to be included in ICD-11 (see beta version: http://bit.ly/1GoZamZ)
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   20 to 24 individual sessions of integrative cognitive behavioral therapy for prolonged grief (PG-CBT; Pfoh, Kotoucová & Rosner, 2015). Sessions are scheduled weekly whenever possible, a session lasting 50 minutes, although some sessions can be combined (100 min). The overall length of treatment is about 6 months.
  •   20 to 24 individual sessions of present-centered therapy (PCT; Schnurr, Friedman, Foy et al., 2003; Shea, Bernardy, Howard, Key, & Lambert, 2003). Sessions are scheduled weekly whenever possible, a session lasting 50 minutes, although some sessions can be combined (100 min). The overall length of treatment is about 6 months.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Severity of prolonged grief symptoms 12 months after randomization, measured with the German version (Rosner, Pfoh & Kotoucová, 2015) of the Interview for Prolonged Grief-13 (PG-13; Prigerson, Horowitz, Jacobs et al., 2009)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Post-treatment:
Prolonged grief symptom severity, measured with the German version (Rosner, Pfoh & Kotoucová, 2015) of the Interview for Prolonged Grief-13 (PG-13; Prigerson, Horowitz, Jacobs et al., 2009)

12 months after randomization and post-treatment:
• overall mental health, measured with the Global Severity Index (GSI) of the German version of the Brief Symptom Inventory (BSI; Franke, 2000)
• depressive symptoms, measured with the German revised version of the Beck Depression Inventory (BDI-II; Hautzinger, Keller, & Kühner, 2009)
• severity of somatoform symptoms according to the SOMS-7 (Rief & Hiller, 2008)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
  • University Medical Center 
  • other 
  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/10/26
  •   204
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- primary diagnosis of prolonged grief disorder (PGD) as assessed in the PG-13 interview (Prigerson, Horowitz, Jacobs et al., 2009; German version: Rosner, Pfoh & Kotoucová, 2015)
- sufficient cognitive skills
- sufficient German language skills
- informed consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- current psychotic disorder
- severe substance use disorder
- acute suicidality
- ongoing psychotherapy
- treatment regime for antidepressant medication not yet stable for four weeks
- continuous treatment with benzodiazepines, antipsychotics, or opioids
- participation in another treatment trial

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Katholische Universität Eichstätt-Ingolstadt
    • Ms.  Prof. Dr.  Gabriele  Gien 
    • Ostenstraße 26
    • 85072  Eichstätt
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Universitätsklinikum Leipzig
    • Ms.  Prof. Dr.  Anette  Kersting 
    • Semmelweisstraße 10
    • 04103  Leipzig
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Philipps-Universität Marburg
    • Mr.  Prof. Dr.  Winfried  Rief 
    • Gutenbergstraße 18
    • 35032  Marburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Goethe-Universität Frankfurt am Main
    • Ms.  PD Dr.  Regina  Steil 
    • Varrentrappstr. 40-42
    • 60486  Frankfurt am Main
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Philipps-Universität Marburg; Koordinierungszentrum für Klinische Studien Marburg (KKS Marburg)
    • Karl-von-Frisch-Straße 4
    • 35043  Marburg
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Katholische Universität Eichstätt-Ingolstadt; Lehrstuhl Klinische und Biologische Psychologie
    • Ms.  Prof. Dr.  Rita  Rosner 
    • Ostenstr. 25
    • 85072  Eichstätt
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Katholische Universität Eichstätt-Ingolstadt; Lehrstuhl Klinische und Biologische Psychologie
    • Ms.  Dipl.-Psych.  Eline  Rimane 
    • Levelingstr. 7
    • 85049  Ingolstadt
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.