Effects of an Internet-based Intervention for Posttraumatic Stress Disorder

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Posttraumatic Stress Disorder (PTSD)	Behavioral: Exposure for PTSD with cognitive restructuring; Behavioral: Exposure for PTSD without cognitive restructuring	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	293 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Additive Effect of Cognitive Restructuring in a Web-based Treatment for Traumatized Arab People
Study Start Date :	December 2011
Actual Primary Completion Date :	December 2015
Actual Study Completion Date :	December 2015

Arms and Interventions

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Arm	Intervention/treatment
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)	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.
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)	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.

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

Germany
Treatment Center for Torture Victims Berlin/Freie Universität Berlin
Berlin, Germany, 10559

Sponsors and Collaborators

Berlin Center for the Treatment of Torture Victims

Investigators

Study Chair:	Christine Knaevelsrud, PhD	Freie Universität Berlin

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Treatment web-page 

Responsible Party:	Christine Knaevelsrud, Clinical Professor, Berlin Center for the Treatment of Torture Victims
ClinicalTrials.gov Identifier:	NCT01508377 History of Changes
Other Study ID Numbers:	CTTV-001
First Posted:	January 12, 2012
Last Update Posted:	February 2, 2016
Last Verified:	January 2016

Keywords provided by Christine Knaevelsrud, Berlin Center for the Treatment of Torture Victims:

posttraumatic stress disorder; internet-based psychotherapy; cognitive restructuring; exposure

Additional relevant MeSH terms:

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders