Trial document





This trial has been registered retrospectively.
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  DRKS00015325

Trial Description

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Title

Psychometric review of the German Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

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Trial Acronym

CAPS-5

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URL of the Trial

http://www.kli.psy.ruhr-uni-bochum.de/klipsy/projekte/CAPS5.html

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Brief Summary in Lay Language

Central to the adequate treatment of persons with mental disorders is a comprehensive and accurate diagnosis. Structured clinical interviews are the gold standard of clinical-psychological diagnostics.
In 2013, the American Psychiatric Association published the fifth edition of the Diagnostic and Statistical Manual for Mental Disorders (DSM-5), which involved altering a variety of mental health criteria. This now makes it necessary to adapt existing diagnostic instruments to the new criteria and to review their use in routine clinical conditions. The Clinician-Administered PTSD Scale for DSM-5 [CAPS-5] is a structured diagnostic interview for posttraumatic stress disorder that is already established in clinical-psychological everyday life and now adapted to the new disorder criteria. The aim of this study is to assess the applicability and reliability of the CAPS-5 and to check its objectivity, accuracy, and validity.

For this purpose, two measurements will take place at one-week intervals. At each measurement time point, persons who have experienced a traumatic event will be interviewed by an interviewer using the CAPS-5 and asked to complete a questionnaire battery. In addition, a short interview on other potentially relevant, non-trauma-related areas of disturbance will be carried out for one of the two measurement times.

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Brief Summary in Scientific Language

Following the revision of the diagnostic criteria for the Diagnostic and Statistical Manual for Mental Disorders (DSM-5, American Psychiatric Association, 2013), the criteria of the posttraumatic stress disorder (PTSD) have been extensively reviewed. As a result, diagnostic instruments must also be adapted to the new criteria and reviewed with regard to their psychometric quality. One of these instruments is the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), which is recommended by professional societies and the S3 guidelines for PTSD as a diagnostic interview.

The aim of this study is to review the psychometric quality of the German translation of the CAPS-5 (Cwik & Woud, 2015) as comprehensively as possible. For this purpose, a multi-trait-multi-method design should be used to diagnose patients with multiple trauma as well as after mono-traumatic experiences with PTSD and traumatized persons without PTSD using the CAPS-5. The interviews are conducted in routine clinical settings: both civil patients in full inpatient and outpatient settings are interviewed as well as soldiers after stressful operational experience. Therefore, these individuals are first asked to fill out a comprehensive questionnaire battery, which includes both constructual and non-constructional questionnaires, and are then interviewed by trained individuals. At one-week intervals, this procedure is repeated, whereby the interview is carried out by another (blinded) person. All interviews will be recorded on tape. In addition, the short version of the Diagnostic Interview for Mental Disorders - Open Access (Mini-DIPS-OA, Margraf & Cwik, 2017) will be performed at the first measurement point in order to detect comorbid disorders.

This design allows us to check the construct validity (convergent and divergent validity) of the CAPS-5 as well as various facets of reliability. Through the two consecutive interviews, the test-retest reliability can be determined, whereas counter ratings of blinded assessments will be used to determine the inter-rater reliability. In addition, further analysis will examine the psychometric quality of the interview (e.g., confirmatory factor analyses, receiver operating characteristic analyses, and network analyses).

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Organizational Data

  •   DRKS00015325
  •   2019/01/10
  •   [---]*
  •   yes
  •   Approved
  •   331, Bochum - Ethik-Kommission der Psychologischen Fakultät der Ruhr-Universität Bochum Ruhr-Universität Bochum Fakultät für Psychologie - Dekanat - Gebäude GAFO 04/262 D-44780 Bochum Tel. +49 234 32 24606 FAX: +49 234 32 14588 http://www.psy.ruhr-uni-bochum.de/zentralebereiche/ethik.html.de
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F43.1 -  Post-traumatic stress disorder
  •   F43.8 -  Other reactions to severe stress
  •   F43.9 -  Reaction to severe stress, unspecified
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Interventions/Observational Groups

  •   Subjects:
    Multiple traumatized patients with post-traumatic stress disorder

    Study design:
    Using a multi-trait-multi-method design, the study participants will be interviewed by a trained person by using the CAPS-5 interview regarding the presence of a post-traumatic stress disorder. Additionally, all participants are asked to fill out a comprehensive questionnaire battery, which includes both constructual and non-constructional questionnaires. At one-week intervals, this procedure is repeated, whereby the interview is carried out by another (blinded) person. All interviews will be recorded on tape. In addition, the short version of the Diagnostic Interview for Mental Disorders - Open Access (Mini-DIPS-OA, Margraf & Cwik, 2017) will be performed at the first measurement point in order to detect comorbid disorders.
  •   Subjects:
    Mono-traumatized patients with post-traumatic stress disorder

    Study design:
    Using a multi-trait-multi-method design, the study participants will be interviewed by a trained person by using the CAPS-5 interview regarding the presence of a post-traumatic stress disorder. Additionally, all participants are asked to fill out a comprehensive questionnaire battery, which includes both constructual and non-constructional questionnaires. At one-week intervals, this procedure is repeated, whereby the interview is carried out by another (blinded) person. All interviews will be recorded on tape. In addition, the short version of the Diagnostic Interview for Mental Disorders - Open Access (Mini-DIPS-OA, Margraf & Cwik, 2017) will be performed at the first measurement point in order to detect comorbid disorders.
  •   Subjects:
    Traumatized control subjects without post-traumatic stress disorder

    Study design:
    Using a multi-trait-multi-method design, the study participants will be interviewed by a trained person by using the CAPS-5 interview regarding the presence of a post-traumatic stress disorder. Additionally, all participants are asked to fill out a comprehensive questionnaire battery, which includes both constructual and non-constructional questionnaires. At one-week intervals, this procedure is repeated, whereby the interview is carried out by another (blinded) person. All interviews will be recorded on tape. In addition, the short version of the Diagnostic Interview for Mental Disorders - Open Access (Mini-DIPS-OA, Margraf & Cwik, 2017) will be performed at the first measurement point in order to detect comorbid disorders.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Blinded
  •   assessor
  •   Other
  •   Diagnostic
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

The primary endpoint will be PTSD symptoms, as measured by the self-rating questionnaires. Therefore, the following two questionnaires will be used:

1. PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5)

2. Impact of Event Scale – Revision (IES-R)

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Secondary Outcome

Secondary endpoints are subdivided into endpoints to measure convergent and divergent validity.

Secondary endpoints for determining convergent validity are:

1. Beck Depression Inventory - Revision (BDI-II)

2. State-Trait Anxiety Inventory (STAI)

3. Dissociative Experiences Scale (DES).

4. Questionnaire of Thoughts and Feelings (QTF).

5. Screening for Complex Post-traumatic Stress Disorder (SCPTSD)

6. Symptom-Checklist-90-Revised (SCL-90-R) – Global Severity Index (GSI).




Secondary endpoints for determining divergent validity are:

1. Symptom-Checklist-90-Revised (SCL-90-R) – six subscales: (1) somatization, (2) obsession-compulsion, (3) interpersonal sensitivity, (4) phobic anxiety, (5) paranoid ideation, and (6) psychoticism

2. Concerning the Patient Acceptance Questionnaire (CPAQ)

3. Balanced Inventory of Desirable Responding (BIDR)

In addition to construct validity, the secondary endpoints to be assessed are the inter-rater reliability and test-retest reliability of the CAPS-5, as well as the stability of the factor structure of CAPS-5-related PTSD symptoms. To determine the inter-rater reliability, all interviews are recorded on tape and then countered by blinded interviewers. On the other hand, the test-retest reliability is determined by carrying out a second interview with another blinded interviewer one week later. Finally, the stability of the factor structure will be evaluated using convergent factor analyses.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • other 
  • Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2016/12/15
  •   219
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Experiencing an event that is classified as a traumatic event according to DSM-5

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Exclusion Criteria

Inadequate knowledge of German language

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Addresses

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    • Lehrstuhl für Klinische Psychologie und Psychotherapie, Humanwissenschaftliche Fakultät, Universität zu Köln
    • Mr.  Dr.  Jan Christopher  Cwik 
    • Pohligstr. 1
    • 50969  Köln
    • Germany
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    • LWL-Universitätsklinikum Bochum, Ruhr-Universität Bochum
    • Mr.  Prof. Dr.  Henrik  Kessler 
    • Alexandrinenstraße 1-3
    • 44791  Bochum
    • Germany
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    • Lehrstuhl für Klinische Psychologie und Psychotherapie, Humanwissenschaftliche Fakultät, Universität zu Köln
    • Mr.  Dr.  Jan Christopher  Cwik 
    • Pohligstr. 1
    • 50969  Köln
    • Germany
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    • Lehrstuhl für Klinische Psychologie und Psychotherapie, Humanwissenschaftliche Fakultät, Universität zu Köln
    • Mr.  Dr.  Jan Christopher  Cwik 
    • Pohligstr. 1
    • 50969  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Lehrstuhl für Klinische Psychologie und Psychotherapie, Humanwissenschaftliche Fakultät, Universität zu Köln
    • Mr.  Dr.  Jan Christopher  Cwik 
    • Pohligstr. 1
    • 50969  Köln
    • Germany
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Status

  •   Recruiting ongoing
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* This entry means the parameter is not applicable or has not been set.