Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of an Internet-based Intervention for Posttraumatic Stress Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Berlin Center for the Treatment of Torture Victims.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Christine Knaevelsrud, Berlin Center for the Treatment of Torture Victims
ClinicalTrials.gov Identifier:
NCT01508377
First received: December 22, 2011
Last updated: January 11, 2012
Last verified: January 2012

December 22, 2011
January 11, 2012
December 2011
June 2013   (final data collection date for primary outcome measure)
Change in posttraumatic stress [ Time Frame: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment), 12-months-follow-up (12 months after the treatment) ] [ Designated as safety issue: No ]
Change in Posttraumatic Stress Diagnostic Scale from baseline to post-treatment, 3-months-follow-up and 12-months-follow-up
Same as current
Complete list of historical versions of study NCT01508377 on ClinicalTrials.gov Archive Site
  • Change in anxiety [ Time Frame: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment), 12-months-follow-up (12 months after the treatment) ] [ Designated as safety issue: No ]
    Change in Hopkins Symptom Checklist-25 from baseline to post-treatment, 3-months-follow-up and 12-months-follow-up
  • Change in depression [ Time Frame: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment), 12-months-follow-up (12 months after the treatment) ] [ Designated as safety issue: No ]
    Change in Hopkins Symptom Checklist-25 from baseline to post-treatment, 3-months-follow-up and 12-months-follow-up
Same as current
Not Provided
Not Provided
 
Effects of an Internet-based Intervention for Posttraumatic Stress Disorder
Effects of Exposure for Posttraumatic Stress Disorder With and Without Cognitive Restructuring in an Internet-based Intervention

For several years now, a very successful treatment of posttraumatic stress disorders has been offered in the Netherlands and in Germany. The contact between clients and therapists takes place exclusively via Internet. The therapists follow a scientifically tested treatment protocol, that defines fixed treatment elements that are adapted to the specific situation of the client. The participants can write at home, in their familiar environment which makes it easier to work on trauma related issues with their therapist. In the last years the treatment was offered in Arabic as well indicating to be an effective treatment for Posttraumatic Stress Disorder (PTSD) in Arabic-speaking countries.

The treatment lasts five weeks. During that time-frame, participants write several texts. The participants decide when they want to write. Each time after having received two texts, the therapists provide feedback and further instructions. The therapists are all trained psychologists, who have received additional training in the interpretation of texts and for the application of the treatment protocol.

The investigators hypothesize that both interventions will significantly improve clinical symptoms of PTSD. Furthermore, the investigators expect improvements in secondary outcomes such as anxiety, somatization and quality of life.

Background:

For several years now, a very successful treatment of posttraumatic stress disorders has been offered in the Netherlands and in Germany. The contact between clients and therapists takes place exclusively via Internet. The therapists follow a scientifically tested treatment protocol, that defines fixed treatment elements that are adapted to the specific situation of the client. The participants can write at home, in their familiar environment which makes it easier to work on trauma related issues with their therapist. In the last years the treatment was offered in Arabic as well indicating to be an effective treatment for PTSD in Arabic-speaking countries.

Method:

Traumatized Arabic-speaking participants are allocated at random to a long version (10 sessions) of a manualized writing approach over 6 weeks or to a short version, where the part concerning the cognitive restructuring is excluded. The investigators expect the treatment to be useful for traumatized clients, especially for those who have no access to psychological help otherwise and they hypothesize that both interventions will significantly improve clinical symptoms of PTSD. Furthermore, the investigators expect improvements in secondary outcomes such as anxiety, somatization and quality of life. Additionally the investigators are interested, if the short form where the cognitive part is excluded and the focus will be more on confrontation is effective similarly.

Conclusion:

If the interventions prove to be an effective treatment for PTSD in Arabic-speaking countries, the results will lend to support to the establishment of internet-based approaches, especially in countries, where face-to-face therapy cannot be provided. Furthermore a shorter treatment could improve the compliance of the participants, particularly in post-conflict regions where people cannot attend long therapeutic interventions.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Posttraumatic Stress Disorder (PTSD)
  • Behavioral: Exposure for PTSD with cognitive restructuring

    The treatment lasts five weeks. During that time-frame, participants write ten texts for 45 minutes, twice a week. Each time after having received two texts, the therapists provide feedback and further instructions, which are based upon the manual (Lange et al., 2003)

    The long version of the PTSD treatment (including cognitive restructuring) can be divided into three phases.

    First phase - self-confrontation (4 essays) At the beginning the participants receive psychoeducation about the mechanisms of exposure before writing four essays about their emotionally most painful memories.

    Second phase - cognitive restructuring (4 essays) Again the participants write four texts, however, this time they go beyond mere descriptions and use their experiences to write a supportive letter to an imaginary friend who had been through the same experience.

    Third phase - parting (2 essays) In the third phase, two texts are written in the form of a letter to document the past in a worthy document.

  • Behavioral: Exposure for PTSD without cognitive restructuring

    The treatment lasts five weeks. During that time-frame, participants write ten texts for approximately 45 minutes, twice a week. Each time after having received two texts, the therapists provide feedback and further instructions, which are based upon the manual (Lange et al., 2003).

    The short version of the PTSD treatment can be divided into only two phases. Compared to the long version the phase dealing with cognitive restructuring is excluded.

    First phase - self-confrontation (4 essays) At the beginning the participants receive psychoeducation about the mechanisms of exposure before writing four essays about their emotionally most painful memories.

    Third phase - parting (2 essays) In the third phase, two texts are written in the form of a letter to document the past in a worthy document.

  • Experimental: Treatment of PTSD with cognitive restructuring

    In this arm the PTSD treatment can be divided into three phases.

    First phase: self-confrontation (4 essays)

    Second phase: cognitive restructuring (4 essays)

    Third phase: parting (2 essays)

    Intervention: Behavioral: Exposure for PTSD with cognitive restructuring
  • Experimental: Treatment of PTSD without cognitive restructuring

    In this arm the PTSD treatment can be divided into only two phases. Compared to the other arm the phase dealing with cognitive restructuring is excluded.

    First phase: self-confrontation (4 essays)

    Second phase: parting (2 essays)

    Intervention: Behavioral: Exposure for PTSD without cognitive restructuring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • traumatic experience
  • must suffer from posttraumatic stress
  • must be fluent in written Arabic
  • must have access to the Internet during the treatment

Exclusion Criteria:

  • suicidal intentions
  • substance abuse
  • psychotic experience
  • dissociation
  • currently receiving psychotherapy elsewhere
  • serious depression with BDI score > 29
Both
18 Years and older
No
Contact: Christine Knaevelsrud, PhD 0049 (0)30 30390623 c.knaevelsrud@bzfo.de
Contact: Birgit Wagner, PhD 0049 (0)341 9718861 birgit.wagner@medizin.uni-leipzig.de
Germany
 
NCT01508377
CTTV-001
No
Christine Knaevelsrud, Berlin Center for the Treatment of Torture Victims
Berlin Center for the Treatment of Torture Victims
Not Provided
Study Chair: Christine Knaevelsrud, PhD Treatment Center for Torture Victims Berlin
Berlin Center for the Treatment of Torture Victims
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP