- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01508377
Effects of an Internet-based Intervention for Posttraumatic Stress Disorder
Additive Effect of Cognitive Restructuring in a Web-based Treatment for Traumatized Arab People
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Berlin, Germany, 10559
- Treatment Center for Torture Victims Berlin/Freie Universität Berlin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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) |
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) |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)
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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
|
baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)
|
Change in quality of life
Time Frame: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)
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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)
|
Collaborators and Investigators
Investigators
- Study Chair: Christine Knaevelsrud, PhD, Freie Universität Berlin
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTTV-001
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