Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000486

Trial Description

start of 1:1-Block title

Title

prevention of depressive episodes on patients with Inflammatory Bowel Diesease

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

Description: This survey will try to analyze how far the incidence of depressive episodes in patients with inflammatory bowel diseases can be reduced by psychological intervention. The aim is to decrease the scale of depression, measured by two standardized questionnaires: ADS (Allgemeine Depressionsskala) and BDI (Beck- Depressions-Inventar). Intervention itself is based on cognitive behavioural therapy (Hautzinger and Welz 2004), done as a group tutorial. The patients shall improve their abilities concerning their self-perception as well as their emotion-regulation skills. This is supposed to lessen depressive decompensations in the future.
Psychological prevention takes its time to show the complete effect in everyday life.Therefore the impact-review will be done 12 months after the intervention.


Background: The origin of inflammatory bowel diseases (M. Crohn and Colitis ulcerosa) is still not without ambiguity. There is genetical predisposition discussed as well as immunological deficiency. Inflammatory bowel deseases are one of the most common gastroenterological diseases in the world (Ohman and Simren 2010).
Interaction with mental factors is also not clearly understood, but it can assured that patients with inflammatory bowel diseases show a significantly higher prevalence for depressive symptoms (Fuller-Thomson & Sulman 2006).
Furthermore depressions can trigger a new episode of inflammation on established inflamatory bowel desease. This was shown in an animal-experiment in which mice were given depression-causing drugs. (Ghia JE, Blennerhassett P, 2009).
Because of this it might be possible to avoid a new imflammational attack by lessening the depressive episodes. Future depressive phases could also be prevented so that quality of life would be perceived as higher even in times of remission .
That prevention of depression is efficient was shown in the past. This study will also refer to the cognitive behavioural therapy, which has proved to be successful (Hautzinger, Welz 2004).

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

Brief Summary in Scientific Language

Description: This survey will try to analyze how far the incidence of depressive episodes in patients with IBD (inflammatorx bowel disease) can be reduced by psychological intervention. The aim is to decrease the scale of depression on ADS (Allgemeine Depressionsskala, Hautzinger, Bailer, 1993) and BDI (Beck- Depressions-Inventar, Schmitt et al. 2006). Intervention itself is based on cognitive behavioural therapy (Hautzinger and Welz 2004), done as a group tutorial. The patients shall improve their abilities concerning their self-perception as well as their emotion-tegulation skills. This is supposed to lessen depressive decompensations in the future.
Psychological prevention takes its time to show the complete effect in everyday life.Therefore the impact-review will be done 12 months after the intervention.


Background: The origin of inflammatory bowel diseases (IBD) is still not without ambiguity. There is genetical predisposition discussed as well as immunological deficiency. IBD is one of the most common gastroenterological diseases in the world (Ohman and Simren 2010).
Interaction of IBD with mental factors is also not clearly understood, but it can assured that patients with IBD show a significantly higher prevalence for depressive symptoms (Fuller-Thomson & Sulman 2006).
Furthermore depressions can trigger a new episode of inflammation on established IBD. This was shown in an animal-experiment in which mice were given depression-causing drugs. (Ghia JE, Blennerhassett P, Deng Y, Verdu EF, Khan WI, Collins SM. 2009).
Because of this it might be possible to avoid a new imflammational attack by lessening the depressive episodes. Future depressive phases could also be prevented so that quality of life would be perceived as higher even in times of remission .
That prevention of depression is efficient was shown in the past. This study will also refer to the cognitive behavioural therapy, which has proved to be successful (Hautzinger, Welz 2004).

Expected effect: According to two similar studies a middle effect of at least 0.5 can be expected.

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

Organizational Data

  •   DRKS00000486
  •   2011/08/26
  •   [---]*
  •   yes
  •   Approved
  •   BB72/10, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
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

  •   F32 -  Depressive episode
  •   K50 -  Crohn's disease [regional enteritis]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Intervention:
    group tutorial based on cognitive behavioural therapy. Aim is to improve self-management-skills in order to prevent and cope with depressive episodes. Efficiant stress management is also part of the tutorial.
  •   controlgroup : same affection, but without intervention

end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prevention
  •   Parallel
  •   [---]*
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

pre: level of depression on questionnaires
BDI (Beck- Depressions-Inventar) and ADS (general dpression scale).

post :right after intervention, again level of depression on BDI (Beck- Depressions-Inventar) and ADS (general depression scale).

to compare both groups: IBDQ-D (Inflammatoy-bowel-disease-questionnaire - german version).
level of diesase-specific quality of life.

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

Secondary Outcome

post:

Follow-up After 12 months again on BDI (Beck- Depressions-Inventar) and ADS (Allgemeine Depressionsskala), to check the longterm-effects.

to compare both groups: IBDQ-D (Inflammatoy-bowel-disease-questionnaire - german version).

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

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

Recruitment

  •   Actual
  •   2010/08/30
  •   70
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

confirmed diagnose of an inflammatory bowel desease

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

Exclusion Criteria

foreign language;
use of antidepressant drugs;
serious psychiatric disease;
acute inflammatory episode

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Medizinische Psychologie Universität Greifswald
    • Walther- Rathenau- Straße 48
    • 17487   Greifswald
    • 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
    • Institut für Medizinische Psychologie
    • Mr.  Dr.  Wolfgang  Hannöver 
    • Walther- Rathenau- Straße 48
    • 17487   Greifswald
    • 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
    • Institut für Medizinische Psychologie
    • Mr.  Dr.  Wolfgang  Hannöver 
    • Walther- Rathenau- Straße 48
    • 17487   Greifswald
    • 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
    • Ernst-Moritz-Arndt-Universität Greifswald, Medizinische Fakultät, Institut für Medizinische Psychologie
    • Walther-Rathenau-Str. 48
    • 17487  Greifswald
    • 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 complete, follow-up complete
  •   2011/12/22
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Buthut, M.; Hannöver, W.; Hannich, H.-J (2013): Evaluation eines Gruppenprogramms zur Prävention depressiver Episoden bei Patienten mit chronisch entzündlichen Darmerkrankungen (CED). In: Ärztliche Psychotherapie (3), S. 175–181.
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.