Trial document




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  DRKS00010245

Trial Description

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Title

Evaluation of web-based cognitive and behavioural therapeutic components and its change mechanisms for Arab people with posttraumatic stress disorder

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Trial Acronym

[---]*

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URL of the Trial

http://ilajnafsy.bzfo.de/portal/

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Brief Summary in Lay Language

For several years, countries located in the Middle East and North Africa have been affected by violent conflicts and war. These ongoing widespread armed conflicts have an enormous impact on the mental health of the general population. High rates of major depression, anxiety disorders and posttraumatic stress disorder (PTSD) are observed. The increase of violence during the past few years has led to an unrivalled demand for mental health services. Nevertheless, the mental health infrastructure has been totally or partly destroyed in some Arabic-speaking regions. In this situation, psychological interventions via the Internet that have been proven to be
effective in the Western world may offer a solution. Combining the advantages
of high availability, cost-effectiveness, anonymity, stigma-reduction and independence
of the therapist´s location Internet-based interventions may provide a
unique opportunity of psychological support in conflict and post-conflict areas.
The aim of the present study is to evaluate cognitive behavioural therapeutic components delivered via the Internet for Arab people suffering from PTSD. For this purpose, two short online-based interventions (one exposure-based and one cognitive intervention) will be developed on the basis of widely used and efficacious online-based cognitive behavioural treatment approach (Interapy). Both interventions will be translated, culturally shaped and implemented online.
In the present study, we would like to investigate whether both treatment forms are equally feasible, accepted by and suitable for all patients. The question of whether both conditions lead to similar treatment outcomes (e.g. concerning posttraumatic stress symptoms, posttraumatic cognitions and emotions, anxiety, depression and quality of life) should be answered. Both interventions will additionally be compared with an untreated control group (waiting list), in particular to control for spontaneous remission. Furthermore, patient characteristics predicting dropout and treatment outcome should be evaluated to gain a better understanding of change mechanisms of online-based interventions for PTSD in Arab countries.
Eligible patients are Arabic-speaking adults over 18 years of age who had a history of trauma and a posttraumatic stress disorder according to DSM-5.
Amendement: Some changes were made prior to recruitment of participants and data collection: Some additional exclusion criteria (ongoing traumatization (e.g. intense contact with perpetrator ), high depression and bipolar disorder and a participation in our online-based intervention less than 3 months ago), an additional waiting list control group and supplementation of questionnaires at different time points for a detailed analysis of outcomes and subgroups (e.g. social support questionnaire). A second follow-up assessment point (6 months after) treatment was included.

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Brief Summary in Scientific Language

Web-delivered cognitive behavioural interventions are demonstrably efficacious treatments for posttraumatic stress disorder (PTSD) in Western countries. First studies conducted in underserved Arab countries also showed promising results. However, the role of single treatment components remains unclear, particularly in areas of conflict in the Middle East. Furthermore, patient characteristics that might be associated with (web-based) treatment success are unknown in Arab countries.
Thus, the aim of this study is to develop, evaluate and compare two online-based interventions for PTSD. Both interventions will be developed on the basis of a widely used and efficacious online-based writing therapy approach (Interapy). One intervention focuses on reflecting guilt feelings, dysfunctional automatic cognitions and adjusting unrealistic assumptions. The other intervention focuses on exposure-based methods. Both interventions should be compared in respect of acceptance, feasibility and their influence on psychopathological symptoms (e.g. posttraumatic cognitions and anxiety) and resources (quality of life, posttraumatic growth) with each other and with a control group (waiting list).
Exploratory, the impact of patient characteristics (e.g. sociodemographic characteristics) on dropout and therapeutic success should further be determined.

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Organizational Data

  •   DRKS00010245
  •   2016/03/30
  •   [---]*
  •   yes
  •   Approved
  •   107 /2016, Ethikkommission der Freien Universität Berlin
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Secondary IDs

  •   U1111-1181-3047 
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Health Condition or Problem studied

  •   F43.1 -  Post-traumatic stress disorder
  •   depression, anxiety, prolonged grief
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Interventions/Observational Groups

  •   Web-delivered exposure-focused therapy:
    The exposure-based intervention is based on a Dutch web-based cognitive behavioural treatment approach for PTSD (Interapy) that is translated into modern standard Arabic (standard for written language in Arab regions) and culturally shaped. The intervention encompass of two weekly 45-min structured writing assignments. It comprise two components with 6 written accounts over a period of three weeks. Each phases is preceded by psycho-educational information. In the first phase of self-confrontation (exposure) participants are instructed to write four essays about the traumatic event and their related thoughts, fears and physiological reactions. The participants are asked to describe sensory perceptions in detail.
    During the second social sharing phase participants are asked to write two assignments to summarize their memories of the trauma and to consider how they are going to deal with the trauma in the future.
    The therapists give individual feedback and further instructions within 48 hours. The feedback and instructions consist of standard examples that are tailored to the participants´ individual needs. Eight native Arabic speaking therapists living in Egypt and Germany conduct the treatment condition. They are trained in a workshop over several days to use writing exercises in the treatment of PTSD. They also attend weekly supervision meetings via Skype.
  •   Web-delivered cognitive therapy:
    The cognitive intervention is based on a Dutch web-based cognitive behavioural treatment approach for PTSD (Interapy) that is translated into modern standard Arabic (standard for written language in Arab regions) and culturally shaped. As the exposure-based intervention, it consists of two phases over a period of three weeks with six 45-min structured writing assignments. Each phase is preceded by psycho-educational information. The cognitive restructuring phase contain four texts to reflect on guilt feelings, dysfunctional automatic cognitions and to adjust unrealistic assumptions. Participants are instructed to write a letter to a hypothetical friend, who has experienced the same traumatic event.
    During the second social sharing phase participants are asked to write two assignments to summarize their memories of the trauma and to consider how they are going to deal with the trauma in the future.
    The therapists give individual feedback and further instructions within 48 hours. The feedback and instructions consist of standard examples that are tailored to the participants´ individual needs. Eight native Arabic speaking therapists living in Egypt and Germany conduct the treatment condition. They are trained in a workshop over several days to use writing exercises in the treatment of PTSD. They also attend weekly supervision meetings via Skype.
  •   Untreated control group (Waiting list): Clients, allocated to this arm, will receive treatment afterwards (due to ethnical reasons).
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group), Control group receives no treatment
  •   Treatment
  •   Parallel
  •   I
  •   N/A
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Primary Outcome

Posttraumatic stress symptoms will be assessed by the PTSD Checklist for DSM-5 (PCL-5; Weathers, Litz, et al., 2013) at T0, T1, T2 and T3.

Additionally, posttraumatic stress symptoms will be evaluated during treatment.

T0 = pre-treatment
T1 = post-treatment
T2 = 3 months after end of treatment
T3 = 6 months after end of treatment

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Secondary Outcome

Psychopathological secondary outcome measures:

Complicated grief will be assessed by the Prolonged Grief Disorder 13 (PG-13; Prigerson & Maciejewski, 2007).

Depression will be assessed by the Patient Health Questionnaire- Depression Module (PHQ-9; Kroenke, Spitzer, & Williams, 2001) at T0, T1, T2 and T3.

Anxiety will be assessed by the Generalized Anxiety Disorder Scale-7 (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006) at T0, T1, T2 and T3.

Somatic symptoms will be assessed by Patient Health Questionnaire- Somatisation Module (PHQ-15; Kroenke, Spitzer, & Williams, 2002) at T0, T1, T2 and T3.

Quality of life will be assessed by the EUROHIS - Quality of Life (Schmidt, Mühlan, & Power, 2006) at T0, T1, T2 and T3.

Trauma-related secondary outcome measures:

Posttraumatic emotions and cognitions will be assessed by the Trauma Appraisal Questionnaire (TAQ; DePrince et al., 2010) at T0, T1, T2 and T3.

Posttraumatic negative beliefs will be assessed with the Posttraumatic Maladaptive Beliefs Scale (PMBS; Vogt et al., 2012) at T0, T1, T2 and T3.

Guilt cognitions will be assessed with items from the Trauma-Related Guilt Inventory (TRGI; Kubany et al., 1996) at T0, T1,T2 and T3.

Patients evaluation of treatment (satisfaction, working alliance, side effects):

Acceptance of and satisfaction with the online- based treatment will be assessed by self-generated questions (e.g., would you recommend the treatment to another person?) and the Working Alliance Inventory - Short Form (Munder et al., 2010) at T1.

Negative effects of the interventions will be assessed by the inventory for the assessment of negative effects of psychotherapy (INEP; Ladwig et al., 2014) at T1, T2 and T3.

Additional measures (e.g. for subgroup analysis):

Social Support will be assessed by the Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al., 1988).

T0 = pre-treatment
T1 = post-treatment
T2 = 3 months after end of treatment
T3 = 6 months after end of treatment

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Countries of Recruitment

  •   Egypt
  •   Algeria
  •   Bahrain
  •   Morocco
  •   Tunisia
  •   Saudi Arabia
  •   Syrian Arab Republic
  •   Iraq
  •   Lebanon
  •   Jordan
  •   Libyan Arab Jamahiriya
  •   Yemen
  •   Oman
  •   Sudan
  •   United Arab Emirates
  •   Mauritania
  •   Western Sahara
  •   Somalia
  •   Palestinian Territory, Occupied
  •   Kuwait
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2019/05/31
  •   225
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

a) Arabic speaking (speak, read and write Arabic fluently)
b) Internet access during the treatment period
c) a personal E-mail account
d) history of trauma and posttraumatic stress symptoms according to DSM-5

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Exclusion Criteria

a) substance abuse or dependency
b) psychotic symptoms
c) acute suicidal tendency
d) current psychotherapeutic treatment
e) changes in psychotropic medication in the last four weeks
f) ongoing traumatization
g) high depression
h) bipolar disorder
i) Participation in the online-based intervention less than 3 months ago

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Addresses

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    • Zentrum Überleben gGmbH
    • Turmstraße 21
    • 10559  Berlin
    • Germany
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    •   +49 (0)30 30390632
    •   [---]*
    •   [---]*
    •   http://bzfo.de
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    • Freie Universität Berlin
    • Ms.  Prof. Dr.  Christine  Knaevelsrud 
    • Habelschwerdter Allee 45
    • 14195  Berlin
    • Germany
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    • Zentrum Überleben
    • Ms.  Dr.  Maria  Böttche 
    • Turmstraße 21
    • 10559  Berlin
    • Germany
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    • Zentrum Überleben gGmbH
    • Ms.  Johanna  Laskawi 
    • Turmstraße 21
    • 10559  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für wirtschaftliche Zusammenarbeit und Entwicklung Dienstsitz Bonn
    • Postfach 12 03 22
    • 53045  Bonn
    • Germany
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    • MISEREOR Geschäftsstelle Aachen
    • Mozartstraße 9
    • 52064  Aachen
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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