Effects of an Internet-based Intervention for Posttraumatic Stress Disorder

January 30, 2016 updated by: Christine Knaevelsrud, Berlin Center for the Treatment of Torture Victims

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

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

Interventional

Enrollment (Actual)

293

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
baseline, post-treatment (1 day after the treatment), 3-months-follow-up (3 months after the treatment)

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
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 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)
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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Christine Knaevelsrud, PhD, Freie Universität Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 22, 2011

First Submitted That Met QC Criteria

January 11, 2012

First Posted (Estimate)

January 12, 2012

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

January 30, 2016

Last Verified

January 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Posttraumatic Stress Disorder (PTSD)

Clinical Trials on Exposure for PTSD with cognitive restructuring

3
Subscribe