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Completed

NCT Number: NCT01508377

Effects of an Internet-based Intervention for Posttraumatic Stress Disorder

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, depression and quality of life.

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Key information

Conditions

Posttraumatic Stress Disorder (PTSD) Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Treatment Center for Torture Victims Berlin/Freie Universität Berlin

Berlin, 10559, Germany

About this study

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, depression 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • pregnancy

Treatment and study plan

Exposure for PTSD with cognitive restructuring

Behavioral

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.

Exposure for PTSD without cognitive restructuring

Behavioral

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.

Primary outcomes

  1. Change in posttraumatic stress

    Time frame: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)

    Change in Posttraumatic Stress Diagnostic Scale from baseline to post-treatment and 3-months-follow-up

Secondary outcomes

  1. Change in anxiety

    Time frame: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)

    Change in Hopkins Symptom Checklist-25 from baseline to post-treatment and 3-months-follow-up

  2. Change in depression

    Time frame: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)

    Change in Hopkins Symptom Checklist-25 from baseline to post-treatment and 3-months-follow-up

  3. Change in quality of life

    Time frame: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)

    Change in EUROHIS-QOL from baseline to post-treatment and from post-treatment to 3-months-follow-up

Sponsors and collaborators

Lead sponsor

Berlin Center for the Treatment of Torture Victims

Other

Registry information

Official study title

Additive Effect of Cognitive Restructuring in a Web-based Treatment for Traumatized Arab People

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 12, 2012
Registry last updated
Feb 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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