Clinical trial NCT01508377: Effects of an Internet-based Intervention for Posttraumatic Stress Disorder
Official title: Additive Effect of Cognitive Restructuring in a Web-based Treatment for Traumatized Arab People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD)
Keywords: posttraumatic stress disorder
internet-based psychotherapy
cognitive restructuring
exposure
Lead sponsor: Berlin Center for the Treatment of Torture Victims
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in posttraumatic stress
timeFrame: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)
Secondary outcomes:
measure: Change in anxiety
timeFrame: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)
measure: Change in depression
timeFrame: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)
measure: Change in quality of life
timeFrame: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Treatment Center for Torture Victims Berlin/Freie Universität Berlin
Study officials:
affiliation: Freie Universität Berlin
name: Christine Knaevelsrud, PhD
role: STUDY_CHAIR
References:
citation: Bottche M, Wagner B, Vohringer M, Heinrich M, Stein J, Selmo P, Stammel N, Knaevelsrud C. Is only one cognitive technique also effective? Results from a randomized controlled trial of two different versions of an internet-based cognitive behavioural intervention for post-traumatic stress disorder in Arabic-speaking countries. Eur J Psychotraumatol. 2021 Jul 15;12(1):1943870. doi: 10.1080/20008198.2021.1943870. eCollection 2021.