Effects of an Internet-based Intervention for Posttraumatic Stress Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Berlin Center for the Treatment of Torture Victims.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Christine Knaevelsrud, Berlin Center for the Treatment of Torture Victims
ClinicalTrials.gov Identifier:
NCT01508377
First received: December 22, 2011
Last updated: January 11, 2012
Last verified: January 2012
  Purpose

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, somatization and quality of life.


Condition Intervention
Posttraumatic Stress Disorder (PTSD)
Behavioral: Exposure for PTSD with cognitive restructuring
Behavioral: Exposure for PTSD without cognitive restructuring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Exposure for Posttraumatic Stress Disorder With and Without Cognitive Restructuring in an Internet-based Intervention

Resource links provided by NLM:


Further study details as provided by Berlin Center for the Treatment of Torture Victims:

Primary Outcome Measures:
  • Change in posttraumatic stress [ Time Frame: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment), 12-months-follow-up (12 months after the treatment) ] [ Designated as safety issue: No ]
    Change in Posttraumatic Stress Diagnostic Scale from baseline to post-treatment, 3-months-follow-up and 12-months-follow-up


Secondary Outcome Measures:
  • Change in anxiety [ Time Frame: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment), 12-months-follow-up (12 months after the treatment) ] [ Designated as safety issue: No ]
    Change in Hopkins Symptom Checklist-25 from baseline to post-treatment, 3-months-follow-up and 12-months-follow-up

  • Change in depression [ Time Frame: baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment), 12-months-follow-up (12 months after the treatment) ] [ Designated as safety issue: No ]
    Change in Hopkins Symptom Checklist-25 from baseline to post-treatment, 3-months-follow-up and 12-months-follow-up


Estimated Enrollment: 120
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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, somatization 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • serious depression with BDI score > 29
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508377

Contacts
Contact: Christine Knaevelsrud, PhD 0049 (0)30 30390623 c.knaevelsrud@bzfo.de
Contact: Birgit Wagner, PhD 0049 (0)341 9718861 birgit.wagner@medizin.uni-leipzig.de

Locations
Germany
Treatment Center for Torture Victims Berlin Recruiting
Berlin, Germany, 10559
Contact: Christine Knaevelsrud, PhD    0049 (0)30 30390623    c.knaevelsrud@bzfo.de   
Contact: Birgit Wagner, PhD    0049 (0)341 9718861    birgit.wagner@medizin.uni-leipzig.de   
Sponsors and Collaborators
Berlin Center for the Treatment of Torture Victims
Investigators
Study Chair: Christine Knaevelsrud, PhD Treatment Center for Torture Victims Berlin
  More Information

Additional Information:
No publications provided

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
Study First Received: December 22, 2011
Last Updated: January 11, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Berlin Center for the Treatment of Torture Victims:
posttraumatic stress disorder
internet-based psychotherapy
cognitive restructuring
exposure

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014