Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00009007

Trial Description

start of 1:1-Block title

Title

Treatment of posttramaumatic stress disorders in patients in in-patient addiction rehabilitation with the EMDR-method - a randomized controlled trial

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

Trial Acronym

[---]*

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

URL of the Trial

[---]*

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

Brief Summary in Lay Language

In patients with addiction, other additional mental disorders contribute significantly to a difficult course of the disease and worse treatment outcomes. Patients with addiction offen additionally suffer from post-traumatic stress disorder (PTSD): 15-40% of addicted patients are affected by PTSD. Most institutions that consider PTSD in the treatment of addicted patients use a stabilizing approach, such as enhancing competencies to cope with burdening symptoms or to develop individual resources. However, the guidelines for the treatmnet of PTSD recommend a trauma-focused PTSD treatment. 'Eye Movement Desensitization and Reprocessing (EMDR)' is a trauma-focused treatment approach, which has been shown to yield better treatment outcomes than stabilizing procedures. Although the effectiveness of EMDR is well documented for patients with PTSD only, there is rare evidence of the efficacy of EMDR in addicted patients with PTSD. The objective of this randomized controlled trial is to compare the effectiveness of EMDR with the effects of a stabilizing therapy. Both groups will receive addtional stabilizing group-therapy. 158 patients with addiction and PTSD admitted to a rehabilitation clinic will be randomized to either EMDR or the stabilizing treatment. Patients in the EMDR group are expected to show less PTSD symptoms six months after treatment, compared with the control group.

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

Brief Summary in Scientific Language

Patients with substance use disorders, comorbid psychiatric disorders contribute to a worse course of the diseases and a worse treatment outcomes. One of the most common comorbidities is post-traumatic stress disorder (PTSD) which affects 15-40% of the addicted patients. In the stationary addiction rehabilitation, a comorbid PTSD is most often treated by a stabilizing therapy, such as enhancing competencies to cope with burdening symptoms or to develop individual resources. However, guidelines for the treatment of PTSD recommend a trauma-focused treatment approach, such as "Eye Movement Desensitization and Reprocessing (EMDR)", which has shown higher effect sizes compared with stabilizing therapies. Although the effectiveness of EMDR is well documented for patients with PTSD only, there is rare evidence of the efficacy of EMDR in addicted patients with PTSD. The objective of this randomized controlled trial is to compare the effectiveness of EMDR with the effects of a stabilizing therapy. Both groups will receive addtional stabilizing group-therapy. 158 patients with addiction and PTSD admitted to a rehabilitation clinic will be randomized to either EMDR or the stabilizing treatment. Patients in the EMDR group are expected to show less PTSD symptoms 6 months after treatment, compared with the control group.

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

Organizational Data

  •   DRKS00009007
  •   2016/06/01
  •   [---]*
  •   yes
  •   Approved
  •   PV4853, Ethik-Kommission der Ärztekammer Hamburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1172-9213 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F43.1 -  Post-traumatic stress disorder
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Stabilizing PTBS treatment (Treatment as usual)
  •   Stabilizing PTBS treatment (Treatment as usual) and EMDR
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

Primary Outcome

PTBS-symptoms, measured by the Clinician Administered PTSD Scale at 6-month-follow-up

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

Secondary Outcome

Secondary outcomes 6 months after treatment:
PTBS-Symptoms (PTSD Checklist for DSM-5); Alcohol use (mean amount of alcohol per day, number of abstinent days in the last month; Timeline Follow Back); Alcohol /substance use (Alcohol Use Disorders Identification Test; Drug Use Disorders Identification Test); Addiction-related problems (Addiction Severity Index)
Depressive symptoms (Beck Depression Inventory II); Dissociative symptoms (Dissociative Experiences Scale); Emotion regulation (Difficulties in Emotion Regulation Scale); Health-related quality of life (Short-Form 12-Item Health Survey)

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

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

Recruitment

  •   Actual
  •   2015/09/09
  •   158
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

Substance use disorder according to DSM5 (305.00, 303.90, 291.9); at least subsyndromal PTSD according to DSM5, 309.81 (criteria A and B and at least one more criterion of C to E), assessed with the Clinician Administered PTSD-Scale; patient provided informed consent

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

Exclusion Criteria

Severe dissociative symptomatology (Dissociative Experiences Scale > 40); acute suicidality; acute psychotic symptomatology; severe cognitive impairments

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Gesellschaft für Rehabilitationswissenschaften Nordrhein-Westfalen e.V. (GfR)
    • Gartenstraße 194
    • 48147  Münster
    • 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 scientific-contact
    • Zentrum für Interdisziplinäre Suchtforschung (ZIS), c/o Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf
    • Mr.  PD Dr. med.  Ingo  Schäfer 
    • Martinistr. 52
    • 20246  Hamburg
    • 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
    • Zentrum für Interdisziplinäre Suchtforschung (ZIS), c/o Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf
    • Ms.  Dr.  Annett  Lotzin 
    • Martinistr. 52
    • 20246  Hamburg
    • 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
    • Gesellschaft für Rehabilitationswissenschaften Nordrhein-Westfalen e.V. (GfR)
    • Gartenstraße 194
    • 48147  Münster
    • 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.