Effects of an Internet-based Intervention for Posttraumatic Stress Disorder

Posttraumatic Stress Disorder (PTSD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508377
• Other study ID #: CTTV-001
• Status: Completed
• Phase: N/A
• First received: December 22, 2011
• Last updated: January 30, 2016
• Start date: December 2011
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Berlin Center for the Treatment of Torture Victims
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Treatment Center for Torture Victims Berlin/Freie Universität Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Berlin Center for the Treatment of Torture Victims

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in posttraumatic stress	Change in Posttraumatic Stress Diagnostic Scale from baseline to post-treatment and 3-months-follow-up	baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)	No
Secondary	Change in anxiety	Change in Hopkins Symptom Checklist-25 from baseline to post-treatment and 3-months-follow-up	baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)	No
Secondary	Change in depression	Change in Hopkins Symptom Checklist-25 from baseline to post-treatment and 3-months-follow-up	baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)	No
Secondary	Change in quality of life	Change in EUROHIS-QOL from baseline to post-treatment and from post-treatment to 3-months-follow-up	baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)	No

External Links

•   Treatment web-page