Trial document




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  DRKS00016154

Trial Description

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Title

Culturally adapted CBT plus Problem-solving therapy with Afghan Refugees: a pilot study

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Trial Acronym

CACBT+

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URL of the Trial

http://www.psychologie.uni-frankfurt.de/65588084/40_CA-CBT

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Brief Summary in Lay Language

In many countries of the Middle East there is a low mental health literacy. This can result in a higher skepticism towards psychotherapy. The culturally adapted cognitive psychotherapy tries to take these barriers into consideration through multiple interventions. In this study the effect of the therapy will be evaluated by comparing with a control group.

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Brief Summary in Scientific Language

Approximately half of all asylum seekers suffer from trauma-related disorders requiring treatment, among them Posttraumatic Stress Disorder (PTSD), depression, anxiety, and somatic symptoms. There is a lack of easily accessible, low-threshold treatments taking the cultural background into account. Culturally Adapted CBT (CA CBT) is a well evaluated, transdiagnostic group intervention for refugees, using psychoeducation, meditation, and Yoga-like exercises. The objective of this study is to evaluate this group program in a randomized controlled trial with male Farsi-speaking refugees from Afghanistan and Iran and to investigate feasibility with this ethnic group; a group for which
few CBT trials have been reported. The group program was extended by a new, central intervention, the problem solving. Based on an initially calculated power analysis the number of participants was set to 24.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00016154
  •   2018/12/19
  •   [---]*
  •   yes
  •   Approved
  •   288/16, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

  •   U1111-1225-7965 
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Health Condition or Problem studied

  •   F43.1 -  Post-traumatic stress disorder
  •   F32.1 -  Moderate depressive episode
  •   F41.0 -  Panic disorder [episodic paroxysmal anxiety]
  •   F41.1 -  Generalized anxiety disorder
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Interventions/Observational Groups

  •   Arm 1: CACBT is evaluated through a randomized controlled design. The control group is a waitlist group (Care-as-usual). After recruitment patients undergo T1. After patients are randomly assigned to the intervention or waitlist group. The intervention consists of twelve sessions CACBT which are carried out at the Goethe University within six weeks. After treatment another assessment follows. The follow up is implemented one year after.


  •   Arm 2: Care-as-usual, until the waitlist group gains CACBT
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   III
  •   N/A
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Primary Outcome

Within the assessment only validated, clinically and transculturally established instruments will be used. The primary outcome of CACBT is a clinically significant reduction of the GHQ-28 (-5). The GHQ-28 assesses general psychopathological symptoms within the areas of anxiety/insomnia, social functioning, severe depression, somatic complaints. The GHQ-28 will be assessed three times, T1, T2 and Follow up.

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Secondary Outcome

The following areas were defined as secondary outcomes (these will equally be assessed at three times, t1, t2 and follow up): Specific depression symptoms according to the DSM-V, process variables as emotional distancing, trauma specific symptoms, quality of life, social relationships. For assessing the quality of life and social relationships the WHO quality of life brief version (WHOQOL bref) will be used. Depression will be assessed by the PHQ9. The PCL5 assesses trauma symptoms. Emotion Regulation Questionnaire assesses the ability of emotional distancing.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/12/20
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

- Age above 18 years
- Country of origin Iran or Afghanistan
- Diagnosis of a psychic disorder according to the DSM-5

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Exclusion Criteria

- Severe suicidality
- acute psychosis
- current psychotherapy
- addiction

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Addresses

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    • Goethe-Universität FrankfurtKlinische Psychologie
    • Mr.  Prof.  Ulrich  Stangier 
    • Varrentrapptraße 40-42
    • 60486  Frankfurt
    • Germany
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    • Goethe-Universität Frankfurt
    • Mr.  Schahryar  Kananian 
    • Varrentrapstraße 40 - 42
    • 60486  Frankfurt
    • Germany
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    • Goethe-Universität Frankfurt
    • Mr.  Schahryar  Kananian 
    • Varrentrapstraße 40 - 42
    • 60486  Frankfurt
    • Germany
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Sources of Monetary or Material Support

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    • Förderung durch die Stiftung Polytechnische Gesellschaft
    • Untermainanlage 5
    • 60329  Frankfurt am Main
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2020/02/02
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Trial Publications, Results and other Documents

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