Posttraumatic Stress Disorder (PTSD)NCT01508377
Effects of an Internet-based Intervention for Posttraumatic Stress Disorder
A study testing Exposure for PTSD with cognitive restructuring and Exposure for PTSD without cognitive restructuring in people with Posttraumatic Stress Disorder (PTSD), run by Berlin Center for the Treatment of Torture Victims at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Exposure for PTSD with cognitive restructuring and Exposure for PTSD without cognitive restructuring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- traumatic experience
- must suffer from posttraumatic stress
- must be fluent in written Arabic
- must have access to the Internet during the treatment
Who cannot join
- suicidal intentions
- substance abuse
- psychotic experience
- dissociation
- currently receiving psychotherapy elsewhere
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Treatment Center for Torture Victims Berlin/Freie Universität Berlin
Berlin, 10559
About this study
Official title: 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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- Exposure for PTSD with cognitive restructuring, Exposure for PTSD without cognitive restructuring
- Keywords
- posttraumatic stress disorder, internet-based psychotherapy, cognitive restructuring, exposure
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure for PTSD with cognitive restructuringBehavioural
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 restructuringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment of PTSD with cognitive restructuring | Experimental | 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) Receives: Behavioral: Exposure for PTSD with cognitive restructuring |
| Treatment of PTSD without cognitive restructuring | Experimental | 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) Receives: Behavioral: Exposure for PTSD without cognitive restructuring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in posttraumatic stress
Change in Posttraumatic Stress Diagnostic Scale from baseline to post-treatment and 3-months-follow-up
Measured: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)
Secondary outcomes (3)
Change in anxiety
Change in Hopkins Symptom Checklist-25 from baseline to post-treatment and 3-months-follow-up
Measured: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)
Change in depression
Change in Hopkins Symptom Checklist-25 from baseline to post-treatment and 3-months-follow-up
Measured: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)
Change in quality of life
Change in EUROHIS-QOL from baseline to post-treatment and from post-treatment to 3-months-follow-up
Measured: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berlin Center for the Treatment of Torture Victims
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Knaevelsrud, Berlin Center for the Treatment of Torture Victims
- Investigators
- Christine Knaevelsrud, PhD, Study chair, Freie Universität Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508377
- Sponsor's protocol ID
- CTTV-001
- Status last verified
- Jan 2016
- First submitted
- 22 Dec 2011
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34345377
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Effect of Cognitive Restructuring in a Web-based Treatment for Traumatized Arab People
- ClinicalTrials.gov ID
- NCT01508377
- Acronym / sponsor ID
- CTTV-001
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- posttraumatic stress disorder, internet-based psychotherapy, cognitive restructuring, exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Berlin Center for the Treatment of Torture VictimsUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment of PTSD with cognitive restructuring | Experimental | Behavioral: Exposure for PTSD with cognitive restructuringIn 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) |
| Treatment of PTSD without cognitive restructuring | Experimental | Behavioral: Exposure for PTSD without cognitive restructuringIn 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- traumatic experience
- must suffer from posttraumatic stress
- must be fluent in written Arabic
- must have access to the Internet during the treatment
Key exclusion criteria (6 listed)
- suicidal intentions
- substance abuse
- psychotic experience
- dissociation
- currently receiving psychotherapy elsewhere
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure for PTSD with cognitive restructuringThe 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. | Behavioural | Treatment of PTSD with cognitive restructuring |
| Exposure for PTSD without cognitive restructuringThe 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. | Behavioural | Treatment of PTSD without cognitive restructuring |
Primary outcome
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
3 secondary outcomes
Change in anxiety
Time frame: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)
Change in depression
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Derived from this study: PubMed 34345377Bottche 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.
- Treatment web-pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Knaevelsrud, PhD study chair
Freie Universität Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure for PTSD with cognitive restructuring and Exposure for PTSD without cognitive restructuring in people with Posttraumatic Stress Disorder (PTSD), run by Berlin Center for the Treatment of Torture Victims at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in posttraumatic stress (time frame: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01508377, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.